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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG060499-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| Washington University School of Medicine | OTHER |
| University of Pittsburgh | OTHER |
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Modified Application of Cardiac Rehabilitation for Older Adults (MACRO) responds to a critical underuse of cardiac rehabilitation in older adults with a coaching model that addresses issues related to aging as a means to better facilitate cardiac rehabilitation (CR). MACRO is a randomized controlled trial (RCT) in which older adults with a CVD event are randomized between a MACRO intervention (MACRO-I) versus usual care. The MACRO-I is designed to facilitate CR as a means to augment functional recovery.
This is a pragmatic RCT of 350 older adults eligible for CR: hospitalized adults aged ≥70 years with a primary diagnosis of acute myocardial infarction/ acute coronary syndrome, stable ischemic heart disease, revascularization (coronary artery bypass graft surgery, percutaneous coronary intervention), valvular heart disease (surgical or transcatheter valve replacement or repair), heart failure (with reduced or preserved ejection fraction) or peripheral arterial disease. Participants who consent to participate will be randomly assigned to a MACRO-intervention (MACRO-I) versus usual care. In the MACRO-I arm, participants receive coaching that incorporates innovative features designed to address needs of older adults. These include holistic risk assessment (medical, functional, psychosocial), guidance to facilitate CR in a format that aligns with each patient's own risks as well as their preferences (i.e., CR formatted as either site-based, home-based, or in a hybrid format [site transitioning to home]), behavioral reinforcements to promote CR based on their goals of care, and deprescribing of sedating medications. While usual care may include CR, it provides no coaching, and none of the innovations associated with MACRO-I coaching. Endpoints focus particularly on functional capacity achieved by improved implementation of CR.
Aim 1: To establish efficacy, safety, and acceptability of the MACRO-I via a RCT.
We hypothesize that after 3 months, compared to usual care, participants randomized into MACRO-I will have:
H1.1: Greater improvements in function as measured by Activity Measure for Post-Acute Care Computer Adaptive Test (AM-PAC-CAT) Basic Mobility Domain (3 month changes; primary outcome).
H1.2: Greater improvements in function as measured by AM-PAC CAT daily activity domain; accelerometry; depression; frailty; self-efficacy; quality of life.
H1.3: Greater CR participation and adherence. H1.4: Greater impact on readmissions and hospitalization.
Aim 2: To examine the durability of benefit of MACRO-I compared to usual care.
We hypothesize that after 6 and 12 months (12 months will be captured as timing allows), compared to usual care, participants randomized into MACRO-I will have:
H2.1: Greater improvement in AM-PAC-CAT basic mobility and daily activity domains; accelerometry; depression; frailty; self-efficacy; quality of life.
H2.2: Greater impact in readmissions and hospitalization at 6 and 12 months (12 months will be captured as timing allows).
Aim 3: To explore characteristics of patients who benefit the most from the MACRO-I as compared to usual care.
H3.1: We anticipate functional capacity and other baseline characteristics will identify those who benefit from the MACRO-I (exploratory).
The MACRO study originally began recruitment with a target sample size of N=480 in November 2019. The primary outcome measure at this time was the Short Physical Performance Battery (SPPB), and a battery of secondary outcome measures included assessments of hand grip strength, accelerometry, cognition, depression, health literacy, frailty, physical activity, nutrition, readiness for change, self efficacy, and quality of life. However, the COVID-19 pandemic disrupted the original MACRO protocol. In March 2020 per Data Safety and Monitoring Board (DSMB) decision, all study participants who were enrolled at that time were withdrawn and the study was suspended to address safety concerns of face-to-face assessments during the height of the pandemic. It was necessary to modify the protocol so it could administered fully remotely, without changing the original aims and innovation of the intervention.
The SPPB was no longer feasible or safe as a primary outcome measure, so the study team selected the Activity Measure for Post-Acute Care with Computerized Adaptive Testing (AM-PAC CAT). The AM-PAC CAT is used to measure self-reported daily activity, can reliably be used to detect change over time, and can be administered over the phone. It was determined that with this new outcome measure, a target sample size of N=374 would be sufficient to retain the same statistical power for the new primary outcome as the original protocol, assuming 80% retention. The secondary outcome assessments were also revised, changing to measures that could be administered remotely when needed and leaving in-person assessments optional contingent on COVID risk.
Following all regulatory approvals of the revised protocol and outcome measures, the study restarted recruitment in September 2020. Enrollment concluded in August 2023 after 416 participants had been consented and 350 randomized. The retention rate was higher than anticipated at 87.7% completion of the primary outcome measure at 3 months, which allowed for the same amount of power with a smaller sample size.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Active Comparator | Care after an acute heart event will be at the discretion of the participants' clinical providers. |
|
| MACRO-I | Experimental | A coaching intervention that supplements usual care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MACRO-I | Behavioral | MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format [site transitioning to home]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications. |
| Measure | Description | Time Frame |
|---|---|---|
| AM-PAC-CAT - Basic Mobility Domain | AM-PAC-CAT is a self-reported activity limitations measure that assesses perceived difficulty and level of assistance/limitations (Basic Mobility Domain). The Basic Mobility domain characterizes basic movement and physical functioning activities, such as bending, walking, carrying, and climbing stairs. Scaled scores range from 0-104.9 with higher scores indicating greater activity levels/fewer limitations. | 3 months, i.e., Baseline to 3-month change |
| Measure | Description | Time Frame |
|---|---|---|
| AM-PAC-CAT - Basic Mobility Domain | AM-PAC-CAT is a self-reported activity limitations measure that assesses perceived difficulty and level of assistance/limitations (Basic Mobility Domain). The Basic Mobility domain characterizes basic movement and physical functioning activities, such as bending, walking, carrying, and climbing stairs. Scaled scores range from 0-104.9 with higher scores indicating greater activity levels/fewer limitations. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel E Forman | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University in St. Louis | St Louis | Missouri | 63130 | United States | ||
| VA Pittsburgh Healthcare system |
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After informed consent, subjects completed a set of baseline questionnaires. Participants who did not meet the score requirements on the Short Blessed cognitive assessment at baseline were disqualified before randomization. Other reasons for withdrawal prior to randomization assignment included subject-initiated withdrawal, adverse event, death, or loss to follow-up after discharge from inpatient hospital admission. Participants must have completed baseline assessments in order to be randomized.
The original recruitment target was 480 beginning in November 2019. Due to the COVID-19 pandemic, the DSMB recommended suspension and withdrawal of all enrolled subjects in March 2020. The protocol was revised to be fully remote, and recruitment was reinitiated with a smaller target sample in September 2020. Enrollment ended in August 2023. 416 subjects consented to the study (total enrolled), and 350 completed the required baseline assessments to be randomized to an intervention group.
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| ID | Title | Description |
|---|---|---|
| FG000 | MACRO-I | A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format [site transitioning to home]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications. |
| FG001 | Usual Care | Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The baseline analysis population includes all participants who completed the required baseline measures to be randomized to an intervention group. Participants who consented but were withdrawn or disqualified prior to randomization are not included.
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| ID | Title | Description |
|---|---|---|
| BG000 | MACRO-I | A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format [site transitioning to home]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age in years was collected at baseline as part of a demographic questionnaire. The mean age per intervention group is reported. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | AM-PAC-CAT - Basic Mobility Domain | AM-PAC-CAT is a self-reported activity limitations measure that assesses perceived difficulty and level of assistance/limitations (Basic Mobility Domain). The Basic Mobility domain characterizes basic movement and physical functioning activities, such as bending, walking, carrying, and climbing stairs. Scaled scores range from 0-104.9 with higher scores indicating greater activity levels/fewer limitations. | All 350 randomized participants were analyzed with multiple imputation (Markov Chain Monte Carlo or MCMC method) for any missing or incomplete outcomes data. | Posted | Mean | Standard Deviation | score on a scale | 3 months, i.e., Baseline to 3-month change |
|
Adverse event data were collected for all randomized participants over a 1 year follow-up period.
For any fatal SAEs, if a specific cause of death was not available in the medical chart (e.g. due to subject dying outside of the study site hospital system) the CTCAE term was entered as non-specific "death NOS".
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MACRO-I | A coaching intervention that supplements usual care. MACRO-I: MACRO-I coaches engage with patients regularly while they are still inpatients, and then by telephone once they are discharged. Coaching incorporates innovative techniques for holistic risk assessment (medical, functional, psychosocial), guidance to initiate CR in a format aligned with each patient's risks and preferences (i.e., CR as either site-based, home-based, or in a hybrid format [site transitioning to home]), behavioral prompts based on their personal goals of care, and de-prescribing of sedating medications. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANEMIA | Blood and lymphatic system disorders | CTCAE (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANEMIA | Blood and lymphatic system disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Forman, MD | University of Pittsburgh | 412-360-2411 | formand@pitt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 7, 2021 | Jul 25, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 10, 2024 | Aug 7, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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There will be two intervention groups 1) MACRO-I in which the research team will work with the participant and providers to facilitate CR; 2) Usual care as determined by their clinical providers.
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Key investigators and well as the outcomes assessor at each site will remain blinded to participant group placement.
|
| Usual Care | Other | Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm. |
|
| Baseline to 6-month change |
| AM-PAC-CAT - Basic Mobility Domain | AM-PAC-CAT is a self-reported activity limitations measure that assesses perceived difficulty and level of assistance/limitations (Basic Mobility Domain). The Basic Mobility domain characterizes basic movement and physical functioning activities, such as bending, walking, carrying, and climbing stairs. Scaled scores range from 0-104.9 with higher scores indicating greater activity levels/fewer limitations. | Baseline to 12-month change |
| AM-PAC-CAT - Daily Activity Domain | AM-PAC-CAT is a self-reported activity limitations measure that assesses perceived difficulty and level of assistance/limitations (Basic Mobility Domain). The Daily Activity domain characterizes difficulty of daily activities. Scaled scores range from 0-115.4 with higher scores indicating greater activity levels/fewer limitations. | Baseline to 3-month change |
| AM-PAC-CAT - Daily Activity Domain | AM-PAC-CAT is a self-reported activity limitations measure that assesses perceived difficulty and level of assistance/limitations (Basic Mobility Domain). The Daily Activity domain characterizes difficulty of daily activities. Scaled scores range from 0-115.4 with higher scores indicating greater activity levels/fewer limitations. | Baseline to 6-month change |
| AM-PAC-CAT - Daily Activity Domain | AM-PAC-CAT is a self-reported activity limitations measure that assesses perceived difficulty and level of assistance/limitations (Basic Mobility Domain). The Daily Activity domain characterizes difficulty of daily activities. Scaled scores range from 0-115.4 with higher scores indicating greater activity levels/fewer limitations. | Baseline to 12-month change |
| Accelerometry | Change in lifestyle physical activity will be measured by wrist worn accelerometry to assess change in movement. An index of average total active minutes (≥18mg) per 24 hour period will be prioritized to quantify physical activity volume. | Baseline to 3-month change |
| Accelerometry | Change in lifestyle physical activity will be measured by wrist worn accelerometry to assess change in movement. An index of average total active minutes (≥18mg) per 24 hour period will be prioritized to quantify physical activity volume. | Baseline to 6-month change |
| Accelerometry | Change in lifestyle physical activity will be measured by wrist worn accelerometry to assess change in movement. An index of average total active minutes (≥18mg) per 24 hour period will be prioritized to quantify physical activity volume. | Baseline to 12-month change |
| PATIENT HEALTH QUESTIONNAIRE (PHQ-9) | The PHQ-9 is a standardized and validated 9 item depression scale. Scores range from 0-27 points on the scale, with the higher score showing a greater possibility of depression. | Baseline to 3-month change |
| PATIENT HEALTH QUESTIONNAIRE (PHQ-9) | The PHQ-9 is a standardized and validated 9 item depression scale. Scores range from 0-27 points on the scale, with the higher score showing a greater possibility of depression. | Baseline to 6-month change |
| PATIENT HEALTH QUESTIONNAIRE (PHQ-9) | The PHQ-9 is a standardized and validated 9 item depression scale. Scores range from 0-27 points on the scale, with the higher score showing a greater possibility of depression. | Baseline to 12-month change |
| Morley Frail Scale | The Frail Scale is a 5-item assessment of fatigue, resistance, ambulation, illnesses, and loss of weight. Scores range from 0-5 with a higher number indicating greater frailty. | Baseline to 3-month change |
| Morley Frail Scale | The Frail Scale is a 5-item assessment of fatigue, resistance, ambulation, illnesses, and loss of weight. Scores range from 0-5 with a higher number indicating greater frailty. | Baseline to 6-month change |
| Morley Frail Scale | The Frail Scale is a 5-item assessment of fatigue, resistance, ambulation, illnesses, and loss of weight. Scores range from 0-5 with a higher number indicating greater frailty. | Baseline to 12-month change |
| Sullivan Cardiac Self-Efficacy | The Sullivan Cardiac Self-Efficacy scale evaluates an individuals confidence to take care of themselves in association to their cardiac disease. It is scored on scale of 0 to 52 points, with a higher score indicating higher confidence. | Baseline to 3-month change |
| Sullivan Cardiac Self-Efficacy | The Sullivan Cardiac Self-Efficacy scale evaluates an individuals confidence to take care of themselves in association to their cardiac disease. It is scored on scale of 0 to 52 points, with a higher score indicating higher confidence. | Baseline to 6-month change |
| Sullivan Cardiac Self-Efficacy | The Sullivan Cardiac Self-Efficacy scale evaluates an individuals confidence to take care of themselves in association to their cardiac disease. It is scored on scale of 0 to 52 points, with a higher score indicating higher confidence. | Baseline to 12-month change |
| THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Physical Component Score | The Veterans RAND-12 is a short standardized and validated questionnaire evaluating quality of life. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". Both scores range from 0 to 100 with a population mean of 50. These provide an important contrast between physical and psychological health status. A higher score indicates better physical or mental health, respectively. | Baseline to 3-month change |
| THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Physical Component Score | The Veterans RAND-12 is a short standardized and validated questionnaire evaluating quality of life. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". Both scores range from 0 to 100 with a population mean of 50. These provide an important contrast between physical and psychological health status. A higher score indicates better physical or mental health, respectively. | Baseline to 6-month change |
| THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Physical Component Score | The Veterans RAND-12 is a short standardized and validated questionnaire evaluating quality of life. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". Both scores range from 0 to 100 with a population mean of 50. These provide an important contrast between physical and psychological health status. A higher score indicates better physical or mental health, respectively. | Baseline to 12-month change |
| THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Mental Component Score | RAND-12 is a short questionnaire evaluating quality of life. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". These provide an important contrast between physical and psychological health status. | Baseline to 3-month change |
| THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Mental Component Score | RAND-12 is a short questionnaire evaluating quality of life. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". These provide an important contrast between physical and psychological health status. | Baseline to 6-month change |
| THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Mental Component Score | RAND-12 is a short questionnaire evaluating quality of life. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". These provide an important contrast between physical and psychological health status. | Baseline to 12-month change |
| Cardiac Rehabilitation Participation | Participants will be asked about participation and adherence in cardiac rehabilitation as well as participants' medical records to evaluate utilization of cardiac rehab. Participation is measured as the number of sessions attended which ranges from 0 to 36. It is assumed that more sessions attended is better. | 3 months |
| Hospitalizations | Participants will be asked about hospitalizations during blinded monthly calls and follow-up assessments. Participants' medical records may also be reviewed to evaluate readmission to the hospital. Rate of hospitalizations per person year will be reported by group. It is assumed that a lower number of hospitalizations is better. | 12 months |
| Duke Activity Status Index (DASI) | The Duke Activity Status Index (DASI) is a self-reported 12-item scale that has been validated in cardiac patients against peak VO2 and has been demonstrated to be a reliable and responsive tool to quantify physical activity in daily living. Scaled scores range from 0 to 58.2 points, with a higher score corresponding to a higher estimated functional capacity. | Baseline to 3-month Change |
| Duke Activity Status Index (DASI) | The Duke Activity Status Index (DASI) is a self-reported 12-item scale that has been validated in cardiac patients against peak VO2 and has been demonstrated to be a reliable and responsive tool to quantify physical activity in daily living. Scaled scores range from 0 to 58.2 points, with a higher score corresponding to a higher estimated functional capacity. | Baseline to 6-month Change |
| Duke Activity Status Index (DASI) | The Duke Activity Status Index (DASI) is a self-reported 12-item scale that has been validated in cardiac patients against peak VO2 and has been demonstrated to be a reliable and responsive tool to quantify physical activity in daily living. Scaled scores range from 0 to 58.2 points, with a higher score corresponding to a higher estimated functional capacity. | Baseline to 12-month Change |
| Rapid Eating Assessment for Participants (Modified REAP-S) | The modified REAP-S is a self-reported 17-item questionnaire used to assess eating habits. The overall summary score ranges from 17 to 53 points, with a higher score representing healthier dietary patterns. A modified version of the questionnaire was used for this project after receiving approval by the developers of the instrument. | Baseline to 3-month Change |
| Rapid Eating Assessment for Participants (Modified REAP-S) | The modified REAP-S is a self-reported 17-item questionnaire used to assess eating habits. The overall summary score ranges from 17 to 53 points, with a higher score representing healthier dietary patterns. A modified version of the questionnaire was used for this project after receiving approval by the developers of the instrument. | Baseline to 6-month Change |
| Rapid Eating Assessment for Participants (Modified REAP-S) | The modified REAP-S is a self-reported 17-item questionnaire used to assess eating habits. The overall summary score ranges from 17 to 53 points, with a higher score representing healthier dietary patterns. A modified version of the questionnaire was used for this project after receiving approval by the developers of the instrument. | Baseline to 12-month Change |
| Readiness for Change | Interventions like CR that require active engagement by participants are often dependent on the participant's willingness to adopt new activities, habits and routines. The Transtheoretical Model (TTM) is a behavioral framework for understanding readiness for change through 5 change-stages: (1) precontemplation, (2) contemplation, (3) preparation, (4) action, (5) maintenance. Participants in this study are asked at baseline "Are you ready to make some healthy lifestyle changes to help your heart?", and at each follow-up assessment "Since your hospitalization for your heart, have you made or are you making some healthy lifestyle changes to help your heart?" to assess current state of change at each time point. The number of participants in each stage of change will be compared between groups at each timepoint. An increased readiness for change is associated with greater likelihood of goal attainment. | Baseline |
| Readiness for Change | Interventions like CR that require active engagement by participants are often dependent on the participant's willingness to adopt new activities, habits and routines. The Transtheoretical Model (TTM) is a behavioral framework for understanding readiness for change through 5 change-stages: (1) precontemplation, (2) contemplation, (3) preparation, (4) action, (5) maintenance. Participants in this study are asked at baseline "Are you ready to make some healthy lifestyle changes to help your heart?", and at each follow-up assessment "Since your hospitalization for your heart, have you made or are you making some healthy lifestyle changes to help your heart?" to assess current state of change at each time point. The number of participants in each stage of change will be compared between groups at each timepoint. | 3 Months |
| Readiness for Change | Interventions like CR that require active engagement by participants are often dependent on the participant's willingness to adopt new activities, habits and routines. The Transtheoretical Model (TTM) is a behavioral framework for understanding readiness for change through 5 change-stages: (1) precontemplation, (2) contemplation, (3) preparation, (4) action, (5) maintenance. Participants in this study are asked at baseline "Are you ready to make some healthy lifestyle changes to help your heart?", and at each follow-up assessment "Since your hospitalization for your heart, have you made or are you making some healthy lifestyle changes to help your heart?" to assess current state of change at each time point. The number of participants in each stage of change will be compared between groups at each timepoint. | 6 Months |
| Readiness for Change | Interventions like CR that require active engagement by participants are often dependent on the participant's willingness to adopt new activities, habits and routines. The Transtheoretical Model (TTM) is a behavioral framework for understanding readiness for change through 5 change-stages: (1) precontemplation, (2) contemplation, (3) preparation, (4) action, (5) maintenance. Participants in this study are asked at baseline "Are you ready to make some healthy lifestyle changes to help your heart?", and at each follow-up assessment "Since your hospitalization for your heart, have you made or are you making some healthy lifestyle changes to help your heart?" to assess current state of change at each time point. The number of participants in each stage of change will be compared between groups at each timepoint. | 12 Months |
| Fall Assessment | Falls are a common, deleterious, and expensive aspect of aging which may be preventable via the tenets of MACRO such as good transitional care, age-appropriate exercise, and de-prescribing. We will measure falls as follows: at baseline, we will ask, "Have you had any falls in the past 3 months?" In follow-up assessments, we will ask about interim falls, as well as their severity (e.g., if they caused injury). For the outcome assessment, the count of participants in each group who reported having at least one fall over the 12 month period following randomization is reported. | 12 months |
| Pittsburgh |
| Pennsylvania |
| 15240 |
| United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15260 | United States |
| Lost to Follow-up |
|
| Adverse Event |
|
| Death after withdrawal |
|
| Participant was contacted for final visit and declined to complete |
|
| Moved to assisted living and was unreachable for follow-up assessments |
|
| BG001 | Usual Care | Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Sex was collected on the baseline demographics questionnaire. It is reported as the frequency count per group. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Ethnicity was collected on the baseline demographics questionnaire. It is reported as the frequency count of participants per group. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race was collected on the baseline demographics questionnaire (select all that apply). It is reported as the frequency count per group. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Marital Status | Marital status was collected on the baseline demographics questionnaire. It is reported as the frequency count of participants per group. | Count of Participants | Participants |
|
| Social Support | Participants were asked on the baseline demographics survey whether they lived alone or with others. The number of participants in each group who responded that they lived alone, and the number of participants in each group who responded that they lived with others is reported as the count of participants and the percentage of participants out of the total number in each group. | Count of Participants | Participants |
|
| AM-PAC CAT | The AM-PAC-CAT is a self-reported activity limitations measure that assesses perceived difficulty and level of assistance/limitations (Basic Mobility Domain). The Basic Mobility domain characterizes basic movement and physical functioning activities, such as bending, walking, carrying, and climbing stairs. Scaled scores range from 0-104.9 with higher scores indicating greater activity levels/fewer limitations. The Daily Activity domain characterizes difficulty of daily activities. Scaled scores range from 0-115.4 with higher scores indicating greater activity levels/fewer limitations. | Mean | Standard Deviation | score on a scale |
|
| Average total active time/24 hours (minutes) | Change in lifestyle physical activity will be measured by wrist worn accelerometry to assess change in movement. An index of average total active minutes (≥18mg) per 24 hour period will be prioritized to quantify physical activity volume. It is assumed that higher total active time represents a better outcome. | Mean | Standard Deviation | minutes/24 hours |
|
| Patient Health Questionnaire-9 | The PHQ-9 is a standardized and validated 9 item depression scale. Scores range from 0-27 points on the scale, with the higher score showing a greater possibility of depression. | Mean | Standard Deviation | score on a scale |
|
| Morley Frail Scale | The Frail Scale is a 5-item assessment of fatigue, resistance, ambulation, illnesses, and loss of weight. Scores range from 0-5 with a higher number indicating greater frailty. | Mean | Standard Deviation | score on a scale |
|
| Sullivan Cardiac Self Efficacy | The Sullivan Cardiac Self-Efficacy scale evaluates an individuals confidence to take care of themselves in association to their cardiac disease. It is scored on scale of 0 to 52 points, with a higher score indicating higher confidence. | Mean | Standard Deviation | score on a scale |
|
| Veterans RAND-12 | The Veterans RAND-12 is a short standardized and validated questionnaire evaluating quality of life. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". Both scores range from 0 to 100 with a population mean of 50. These provide an important contrast between physical and psychological health status. A higher score indicates better physical or mental health, respectively. | Mean | Standard Deviation | score on a scale |
|
| Modified Rapid Eating Assessment for Participants-Shortened Version | The modified REAP-S is a self-reported 17-item questionnaire used to assess eating habits. The overall summary score ranges from 17 to 53 points, with a higher score representing healthier dietary patterns. A modified version of the questionnaire was used for this project after receiving approval by the developers of the instrument. | Mean | Standard Deviation | score on a scale |
|
| Duke Activity Status Index | The Duke Activity Status Index (DASI) is a self-reported 12-item scale that has been validated in cardiac patients against peak VO2 and has been demonstrated to be a reliable and responsive tool to quantify physical activity in daily living. Scaled scores range from 0 to 58.2 points, with a higher score corresponding to a higher estimated functional capacity. | Mean | Standard Deviation | score on a scale |
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| Fall History | The frequency count of participants who self-reported that they had experienced one or more falls in the past 3 months at the time of the baseline assessment. | Count of Participants | Participants |
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| OG001 | Usual Care | Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm. |
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| Secondary | AM-PAC-CAT - Basic Mobility Domain | AM-PAC-CAT is a self-reported activity limitations measure that assesses perceived difficulty and level of assistance/limitations (Basic Mobility Domain). The Basic Mobility domain characterizes basic movement and physical functioning activities, such as bending, walking, carrying, and climbing stairs. Scaled scores range from 0-104.9 with higher scores indicating greater activity levels/fewer limitations. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 6-month change |
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| Secondary | AM-PAC-CAT - Basic Mobility Domain | AM-PAC-CAT is a self-reported activity limitations measure that assesses perceived difficulty and level of assistance/limitations (Basic Mobility Domain). The Basic Mobility domain characterizes basic movement and physical functioning activities, such as bending, walking, carrying, and climbing stairs. Scaled scores range from 0-104.9 with higher scores indicating greater activity levels/fewer limitations. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12-month change |
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| Secondary | AM-PAC-CAT - Daily Activity Domain | AM-PAC-CAT is a self-reported activity limitations measure that assesses perceived difficulty and level of assistance/limitations (Basic Mobility Domain). The Daily Activity domain characterizes difficulty of daily activities. Scaled scores range from 0-115.4 with higher scores indicating greater activity levels/fewer limitations. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 3-month change |
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| Secondary | AM-PAC-CAT - Daily Activity Domain | AM-PAC-CAT is a self-reported activity limitations measure that assesses perceived difficulty and level of assistance/limitations (Basic Mobility Domain). The Daily Activity domain characterizes difficulty of daily activities. Scaled scores range from 0-115.4 with higher scores indicating greater activity levels/fewer limitations. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 6-month change |
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| Secondary | AM-PAC-CAT - Daily Activity Domain | AM-PAC-CAT is a self-reported activity limitations measure that assesses perceived difficulty and level of assistance/limitations (Basic Mobility Domain). The Daily Activity domain characterizes difficulty of daily activities. Scaled scores range from 0-115.4 with higher scores indicating greater activity levels/fewer limitations. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12-month change |
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| Secondary | Accelerometry | Change in lifestyle physical activity will be measured by wrist worn accelerometry to assess change in movement. An index of average total active minutes (≥18mg) per 24 hour period will be prioritized to quantify physical activity volume. | Posted | Mean | Standard Deviation | minutes/24 hours | Baseline to 3-month change |
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| Secondary | Accelerometry | Change in lifestyle physical activity will be measured by wrist worn accelerometry to assess change in movement. An index of average total active minutes (≥18mg) per 24 hour period will be prioritized to quantify physical activity volume. | Posted | Mean | Standard Deviation | minutes/24 hours | Baseline to 6-month change |
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| Secondary | Accelerometry | Change in lifestyle physical activity will be measured by wrist worn accelerometry to assess change in movement. An index of average total active minutes (≥18mg) per 24 hour period will be prioritized to quantify physical activity volume. | Posted | Mean | Standard Deviation | minutes/24 hours | Baseline to 12-month change |
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| Secondary | PATIENT HEALTH QUESTIONNAIRE (PHQ-9) | The PHQ-9 is a standardized and validated 9 item depression scale. Scores range from 0-27 points on the scale, with the higher score showing a greater possibility of depression. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 3-month change |
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| Secondary | PATIENT HEALTH QUESTIONNAIRE (PHQ-9) | The PHQ-9 is a standardized and validated 9 item depression scale. Scores range from 0-27 points on the scale, with the higher score showing a greater possibility of depression. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 6-month change |
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| Secondary | PATIENT HEALTH QUESTIONNAIRE (PHQ-9) | The PHQ-9 is a standardized and validated 9 item depression scale. Scores range from 0-27 points on the scale, with the higher score showing a greater possibility of depression. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12-month change |
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| Secondary | Morley Frail Scale | The Frail Scale is a 5-item assessment of fatigue, resistance, ambulation, illnesses, and loss of weight. Scores range from 0-5 with a higher number indicating greater frailty. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 3-month change |
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| Secondary | Morley Frail Scale | The Frail Scale is a 5-item assessment of fatigue, resistance, ambulation, illnesses, and loss of weight. Scores range from 0-5 with a higher number indicating greater frailty. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 6-month change |
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| Secondary | Morley Frail Scale | The Frail Scale is a 5-item assessment of fatigue, resistance, ambulation, illnesses, and loss of weight. Scores range from 0-5 with a higher number indicating greater frailty. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12-month change |
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| Secondary | Sullivan Cardiac Self-Efficacy | The Sullivan Cardiac Self-Efficacy scale evaluates an individuals confidence to take care of themselves in association to their cardiac disease. It is scored on scale of 0 to 52 points, with a higher score indicating higher confidence. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 3-month change |
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| Secondary | Sullivan Cardiac Self-Efficacy | The Sullivan Cardiac Self-Efficacy scale evaluates an individuals confidence to take care of themselves in association to their cardiac disease. It is scored on scale of 0 to 52 points, with a higher score indicating higher confidence. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 6-month change |
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| Secondary | Sullivan Cardiac Self-Efficacy | The Sullivan Cardiac Self-Efficacy scale evaluates an individuals confidence to take care of themselves in association to their cardiac disease. It is scored on scale of 0 to 52 points, with a higher score indicating higher confidence. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12-month change |
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| Secondary | THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Physical Component Score | The Veterans RAND-12 is a short standardized and validated questionnaire evaluating quality of life. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". Both scores range from 0 to 100 with a population mean of 50. These provide an important contrast between physical and psychological health status. A higher score indicates better physical or mental health, respectively. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 3-month change |
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| Secondary | THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Physical Component Score | The Veterans RAND-12 is a short standardized and validated questionnaire evaluating quality of life. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". Both scores range from 0 to 100 with a population mean of 50. These provide an important contrast between physical and psychological health status. A higher score indicates better physical or mental health, respectively. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 6-month change |
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| Secondary | THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Physical Component Score | The Veterans RAND-12 is a short standardized and validated questionnaire evaluating quality of life. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". Both scores range from 0 to 100 with a population mean of 50. These provide an important contrast between physical and psychological health status. A higher score indicates better physical or mental health, respectively. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12-month change |
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| Secondary | THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Mental Component Score | RAND-12 is a short questionnaire evaluating quality of life. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". These provide an important contrast between physical and psychological health status. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 3-month change |
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| Secondary | THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Mental Component Score | RAND-12 is a short questionnaire evaluating quality of life. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". These provide an important contrast between physical and psychological health status. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 6-month change |
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| Secondary | THE VETERANS RAND 12-ITEM HEALTH SURVEY (RAND-12) - Mental Component Score | RAND-12 is a short questionnaire evaluating quality of life. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". These provide an important contrast between physical and psychological health status. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12-month change |
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| Secondary | Cardiac Rehabilitation Participation | Participants will be asked about participation and adherence in cardiac rehabilitation as well as participants' medical records to evaluate utilization of cardiac rehab. Participation is measured as the number of sessions attended which ranges from 0 to 36. It is assumed that more sessions attended is better. | Posted | Mean | Standard Deviation | number of sessions attended | 3 months |
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| Secondary | Hospitalizations | Participants will be asked about hospitalizations during blinded monthly calls and follow-up assessments. Participants' medical records may also be reviewed to evaluate readmission to the hospital. Rate of hospitalizations per person year will be reported by group. It is assumed that a lower number of hospitalizations is better. | Posted | Number | events per person year | 12 months |
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| Secondary | Duke Activity Status Index (DASI) | The Duke Activity Status Index (DASI) is a self-reported 12-item scale that has been validated in cardiac patients against peak VO2 and has been demonstrated to be a reliable and responsive tool to quantify physical activity in daily living. Scaled scores range from 0 to 58.2 points, with a higher score corresponding to a higher estimated functional capacity. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 3-month Change |
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| Secondary | Duke Activity Status Index (DASI) | The Duke Activity Status Index (DASI) is a self-reported 12-item scale that has been validated in cardiac patients against peak VO2 and has been demonstrated to be a reliable and responsive tool to quantify physical activity in daily living. Scaled scores range from 0 to 58.2 points, with a higher score corresponding to a higher estimated functional capacity. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 6-month Change |
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| Secondary | Duke Activity Status Index (DASI) | The Duke Activity Status Index (DASI) is a self-reported 12-item scale that has been validated in cardiac patients against peak VO2 and has been demonstrated to be a reliable and responsive tool to quantify physical activity in daily living. Scaled scores range from 0 to 58.2 points, with a higher score corresponding to a higher estimated functional capacity. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12-month Change |
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| Secondary | Rapid Eating Assessment for Participants (Modified REAP-S) | The modified REAP-S is a self-reported 17-item questionnaire used to assess eating habits. The overall summary score ranges from 17 to 53 points, with a higher score representing healthier dietary patterns. A modified version of the questionnaire was used for this project after receiving approval by the developers of the instrument. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 3-month Change |
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| Secondary | Rapid Eating Assessment for Participants (Modified REAP-S) | The modified REAP-S is a self-reported 17-item questionnaire used to assess eating habits. The overall summary score ranges from 17 to 53 points, with a higher score representing healthier dietary patterns. A modified version of the questionnaire was used for this project after receiving approval by the developers of the instrument. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 6-month Change |
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| Secondary | Rapid Eating Assessment for Participants (Modified REAP-S) | The modified REAP-S is a self-reported 17-item questionnaire used to assess eating habits. The overall summary score ranges from 17 to 53 points, with a higher score representing healthier dietary patterns. A modified version of the questionnaire was used for this project after receiving approval by the developers of the instrument. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12-month Change |
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| Secondary | Readiness for Change | Interventions like CR that require active engagement by participants are often dependent on the participant's willingness to adopt new activities, habits and routines. The Transtheoretical Model (TTM) is a behavioral framework for understanding readiness for change through 5 change-stages: (1) precontemplation, (2) contemplation, (3) preparation, (4) action, (5) maintenance. Participants in this study are asked at baseline "Are you ready to make some healthy lifestyle changes to help your heart?", and at each follow-up assessment "Since your hospitalization for your heart, have you made or are you making some healthy lifestyle changes to help your heart?" to assess current state of change at each time point. The number of participants in each stage of change will be compared between groups at each timepoint. An increased readiness for change is associated with greater likelihood of goal attainment. | Posted | Count of Participants | Participants | Baseline |
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| Secondary | Readiness for Change | Interventions like CR that require active engagement by participants are often dependent on the participant's willingness to adopt new activities, habits and routines. The Transtheoretical Model (TTM) is a behavioral framework for understanding readiness for change through 5 change-stages: (1) precontemplation, (2) contemplation, (3) preparation, (4) action, (5) maintenance. Participants in this study are asked at baseline "Are you ready to make some healthy lifestyle changes to help your heart?", and at each follow-up assessment "Since your hospitalization for your heart, have you made or are you making some healthy lifestyle changes to help your heart?" to assess current state of change at each time point. The number of participants in each stage of change will be compared between groups at each timepoint. | 153 participants in the MACRO-I arm and 150 in the Usual Care arm completed the Readiness for Change at the 3 month time point. | Posted | Count of Participants | Participants | 3 Months |
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| Secondary | Readiness for Change | Interventions like CR that require active engagement by participants are often dependent on the participant's willingness to adopt new activities, habits and routines. The Transtheoretical Model (TTM) is a behavioral framework for understanding readiness for change through 5 change-stages: (1) precontemplation, (2) contemplation, (3) preparation, (4) action, (5) maintenance. Participants in this study are asked at baseline "Are you ready to make some healthy lifestyle changes to help your heart?", and at each follow-up assessment "Since your hospitalization for your heart, have you made or are you making some healthy lifestyle changes to help your heart?" to assess current state of change at each time point. The number of participants in each stage of change will be compared between groups at each timepoint. | 144 participants in the MACRO-I arm and 137 in the Usual Care arm completed the Readiness for Change at the 6 month assessment. | Posted | Count of Participants | Participants | 6 Months |
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| Secondary | Readiness for Change | Interventions like CR that require active engagement by participants are often dependent on the participant's willingness to adopt new activities, habits and routines. The Transtheoretical Model (TTM) is a behavioral framework for understanding readiness for change through 5 change-stages: (1) precontemplation, (2) contemplation, (3) preparation, (4) action, (5) maintenance. Participants in this study are asked at baseline "Are you ready to make some healthy lifestyle changes to help your heart?", and at each follow-up assessment "Since your hospitalization for your heart, have you made or are you making some healthy lifestyle changes to help your heart?" to assess current state of change at each time point. The number of participants in each stage of change will be compared between groups at each timepoint. | 137 participants in the MACRO-I arm and 129 in the Usual Care arm completed the Readiness for Change at the 12 month assessment. | Posted | Count of Participants | Participants | 12 Months |
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| Secondary | Fall Assessment | Falls are a common, deleterious, and expensive aspect of aging which may be preventable via the tenets of MACRO such as good transitional care, age-appropriate exercise, and de-prescribing. We will measure falls as follows: at baseline, we will ask, "Have you had any falls in the past 3 months?" In follow-up assessments, we will ask about interim falls, as well as their severity (e.g., if they caused injury). For the outcome assessment, the count of participants in each group who reported having at least one fall over the 12 month period following randomization is reported. | 158 participants in the MACRO-i arm and 153 in Usual Care completed the fall assessment at follow-up. | Posted | Count of Participants | Participants | 12 months |
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| 8 |
| 176 |
| 74 |
| 176 |
| 103 |
| 176 |
| EG001 | Usual Care | Care after an acute heart event will be at the discretion of the participants' clinical providers. Usual Care: Participants will receive usual care that is recommended by their providers. MACRO study personnel will follow the participant for the course of the study to assess endpoints in comparison to the MACRO-I arm. | 12 | 174 | 70 | 174 | 93 | 174 |
| AORTIC VALVE DISEASE | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
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| ATRIAL FIBRILLATION | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
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| ATRIAL FLUTTER | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
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| CARDIAC ARREST | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
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| CARDIAC DISORDERS - OTHER, SPECIFY | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
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| CHEST PAIN - CARDIAC | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
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| HEART FAILURE | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
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| MITRAL VALVE DISEASE | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
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| MYOCARDIAL INFARCTION | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
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| RESTRICTIVE CARDIOMYOPATHY | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
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| SINUS BRADYCARDIA | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
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| SINUS TACHYCARDIA | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
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| SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
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| VENTRICULAR TACHYCARDIA | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
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| VERTIGO | Ear and labyrinth disorders | CTCAE (Unspecified) | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| CONSTIPATION | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| DIARRHEA | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| DUODENAL HEMORRHAGE | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| GASTROINTESTINAL PAIN | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| LOWER GASTROINTESTINAL HEMORRHAGE | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| PANCREATITIS | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| RECTAL HEMORRHAGE | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| UPPER GASTROINTESTINAL HEMORRHAGE | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| DEATH NOS | General disorders | CTCAE (Unspecified) | Systematic Assessment |
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| EDEMA LIMBS | General disorders | CTCAE (Unspecified) | Systematic Assessment |
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| FLU LIKE SYMPTOMS | General disorders | CTCAE (Unspecified) | Systematic Assessment |
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| MULTI-ORGAN FAILURE | General disorders | CTCAE (Unspecified) | Systematic Assessment |
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| NON-CARDIAC CHEST PAIN | General disorders | CTCAE (Unspecified) | Systematic Assessment |
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| PAIN | General disorders | CTCAE (Unspecified) | Systematic Assessment |
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| SUDDEN DEATH NOS | General disorders | CTCAE (Unspecified) | Systematic Assessment |
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| CHOLECYSTITIS | Hepatobiliary disorders | CTCAE (Unspecified) | Systematic Assessment |
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| HEPATOBILIARY DISORDERS - OTHER, SPECIFY | Hepatobiliary disorders | CTCAE (Unspecified) | Systematic Assessment |
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| ENDOCARDITIS INFECTIVE | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
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| INFECTIONS AND INFESTATIONS - OTHER, SPECIFY | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
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| JOINT INFECTION | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
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| LUNG INFECTION | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
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| SEPSIS | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
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| UPPER RESPIRATORY INFECTION | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
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| WOUND INFECTION | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
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| FALL | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
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| FRACTURE | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
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| HIP FRACTURE | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
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| INJURY, POISONING AND PROCEDURAL COMPLICATIONS - OTHER, SPEC | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
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| SPINAL FRACTURE | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
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| VASCULAR ACCESS COMPLICATION | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
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| WOUND DEHISCENCE | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
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| CARDIAC TROPONIN T INCREASED | Investigations | CTCAE (Unspecified) | Systematic Assessment |
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| HYPERGLYCEMIA | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
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| HYPOGLYCEMIA | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
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| ARTHRITIS | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
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| BUTTOCK PAIN | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
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| CHEST WALL PAIN | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
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| GENERALIZED MUSCLE WEAKNESS | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
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| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
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| SOFT TISSUE NECROSIS LOWER LIMB | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
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| NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (Unspecified) | Systematic Assessment |
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| ENCEPHALOPATHY | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
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| INTRACRANIAL HEMORRHAGE | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
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| ISCHEMIA CEREBROVASCULAR | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
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| PARESTHESIA | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
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| STROKE | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
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| SYNCOPE | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
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| TRANSIENT ISCHEMIC ATTACKS | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
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| HALLUCINATIONS | Psychiatric disorders | CTCAE (Unspecified) | Systematic Assessment |
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| SUICIDAL IDEATION | Psychiatric disorders | CTCAE (Unspecified) | Systematic Assessment |
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| ACUTE KIDNEY INJURY | Renal and urinary disorders | CTCAE (Unspecified) | Systematic Assessment |
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| CHRONIC KIDNEY DISEASE | Renal and urinary disorders | CTCAE (Unspecified) | Systematic Assessment |
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| VAGINAL HEMORRHAGE | Reproductive system and breast disorders | CTCAE (Unspecified) | Systematic Assessment |
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| ASPIRATION | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| DYSPNEA | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| PULMONARY EDEMA | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY | Surgical and medical procedures | CTCAE (Unspecified) | Systematic Assessment |
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| HEMATOMA | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment |
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| HYPOTENSION | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment |
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| LYMPHEDEMA | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment |
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| PERIPHERAL ISCHEMIA | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment |
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| VASCULAR DISORDERS - OTHER, SPECIFY | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment |
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| BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY | Blood and lymphatic system disorders | CTCAE (Unspecified) | Systematic Assessment |
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| AORTIC VALVE DISEASE | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
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| ATRIAL FIBRILLATION | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
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| CARDIAC DISORDERS - OTHER, SPECIFY | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
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| CHEST PAIN - CARDIAC | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
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| LEFT VENTRICULAR SYSTOLIC DYSFUNCTION | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
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| MITRAL VALVE DISEASE | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
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| SICK SINUS SYNDROME | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
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| SINUS BRADYCARDIA | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
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| VENTRICULAR ARRHYTHMIA | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
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| VENTRICULAR TACHYCARDIA | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
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| EAR PAIN | Ear and labyrinth disorders | CTCAE (Unspecified) | Systematic Assessment |
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| MIDDLE EAR INFLAMMATION | Ear and labyrinth disorders | CTCAE (Unspecified) | Systematic Assessment |
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| VERTIGO | Ear and labyrinth disorders | CTCAE (Unspecified) | Systematic Assessment |
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| HYPERTHYROIDISM | Endocrine disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| BLURRED VISION | Eye disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| CATARACT | Eye disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| ABDOMINAL DISTENSION | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| COLITIS | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| CONSTIPATION | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| DENTAL CARIES | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| DIARRHEA | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| ESOPHAGEAL OBSTRUCTION | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| GASTRIC ULCER | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| GASTRITIS | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| GASTROINTESTINAL DISORDERS - OTHER, SPECIFY | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| GASTROESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| GASTROINTESTINAL PAIN | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| HEMORRHOIDS | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| ORAL HEMORRHAGE | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| EDEMA LIMBS | General disorders | CTCAE (Unspecified) | Systematic Assessment |
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| FATIGUE | General disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| FLU LIKE SYMPTOMS | General disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| NON-CARDIAC CHEST PAIN | General disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| PAIN | General disorders | CTCAE (Unspecified) | Systematic Assessment |
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| BRONCHIAL INFECTION | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
|
| CONJUNCTIVITIS | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
|
| INFECTIONS AND INFESTATIONS - OTHER, SPECIFY | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
|
| JOINT INFECTION | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
|
| KIDNEY INFECTION | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
|
| LUNG INFECTION | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
|
| PHARYNGITIS | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
|
| RASH PUSTULAR | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
|
| RHINITIS INFECTIVE | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
|
| SHINGLES | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
|
| SINUSITIS | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
|
| TOOTH INFECTION | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
|
| UPPER RESPIRATORY INFECTION | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
|
| BRUISING | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
|
| BURN | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
|
| FALL | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
|
| FRACTURE | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
|
| INJURY TO CAROTID ARTERY | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
|
| INJURY, POISONING AND PROCEDURAL COMPLICATIONS - OTHER, SPECIFY | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
|
| SPINAL FRACTURE | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
|
| VACCINATION COMPLICATION | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
|
| VASCULAR ACCESS COMPLICATION | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
|
| WOUND DEHISCENCE | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
|
| WRIST FRACTURE | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
|
| INVESTIGATIONS - OTHER, SPECIFY | Investigations | CTCAE (Unspecified) | Systematic Assessment |
|
| HYPERKALEMIA | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| HYPOGLYCEMIA | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| HYPOKALEMIA | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| ARTHRITIS | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| BUTTOCK PAIN | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| FLANK PAIN | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| MUSCLE CRAMP | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) - OTHER, SPECIFY | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (Unspecified) | Systematic Assessment |
|
| SKIN PAPILLOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (Unspecified) | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
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| HEADACHE | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| MUSCLE WEAKNESS LEFT-SIDED | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| PARESTHESIA | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
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| PRESYNCOPE | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| SYNCOPE | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
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| TRANSIENT ISCHEMIC ATTACKS | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
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| CONFUSION | Psychiatric disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| HEMATURIA | Renal and urinary disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| RENAL CALCULI | Renal and urinary disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| URINARY URGENCY | Renal and urinary disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| PROSTATIC OBSTRUCTION | Reproductive system and breast disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| DYSPNEA | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| PULMONARY HYPERTENSION | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPE | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| RHINORRHEA | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| WHEEZING | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| ECZEMA | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| RASH ACNEIFORM | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY | Surgical and medical procedures | CTCAE (Unspecified) | Systematic Assessment |
|
| HEMATOMA | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| HYPOTENSION | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| PERIPHERAL ISCHEMIA | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| THROMBOEMBOLIC EVENT | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment |
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