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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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Participation in outpatient cardiac rehabilitation (CR) decreases morbidity and mortality for patients hospitalized with myocardial infarction, coronary bypass surgery or percutaneous revascularization. Unfortunately, only 10-35% of patients for whom CR is indicated choose to participate. Lower socioeconomic status (SES) is a robust predictor of CR non-participation. There is growing recognition of the need to increase CR among economically disadvantaged patients, but there are almost no evidence-based interventions available for doing so. The present study will examine the efficacy of using early case management and financial incentives for increasing CR participation among lower-SES patients. Case management has been effective at promoting attendance at a variety of health-related programs (e.g. treatment for diabetes, HIV, asthma, cocaine dependence) as well as reducing hospitalizations. Financial incentives are also highly effective in altering health behaviors among disadvantaged populations (e.g., smoking during pregnancy, weight loss) including CR participation in a prior trial. For this study 209 CR-eligible lower-SES patients will be randomized to: a treatment condition where patients are assigned a case manager while in hospital who will facilitate CR attendance and coordinate cardiac care, a treatment condition where patients receive financial incentives contingent on initiation of and continued attendance at CR sessions, a combination of these two interventions, or to a "usual-care" condition. Participants in all conditions will complete pre- and post-treatment assessments. Treatment conditions will be compared on attendance at CR and end-of-intervention improvements in fitness, executive function, and health-related quality of life. Cost effectiveness of the treatment conditions will also be examined by comparing the costs of delivering the interventions and the usual care condition, taking into account increases in CR participation. Furthermore, the value of the interventions will be modeled based on increases in participation rates, intervention costs, long-term medical costs, and health outcomes after a coronary event. This systematic examination of promising interventions will allow testing of the efficacy and cost-effectiveness of approaches that have the potential to substantially increase CR participation and significantly improve health outcomes among lower-SES cardiac patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Incentives | Experimental | Patient earns incentives for completing cardiac rehabilitation sessions. |
|
| Case Management | Experimental | Patient is assigned a case manager while in hospital. |
|
| Incentives and Case Management | Experimental | Patient receives both the Incentives and Case Management interventions. |
|
| Usual care | No Intervention | This control condition does not receive either intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Incentives | Behavioral | Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Rehabilitation Attendance | Number of cardiac rehabilitation sessions completed out of a possible 36 | Within 4 months of the intake assessment |
| Cardiac Rehabilitation Completion | Proportion of patients who complete 30+ sessions of cardiac rehabilitation | Within 4 months of the intake assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fitness (Peak Oxygen Uptake) | Changes in fitness level (peak oxygen uptake) will be measured from intake to completion of the intervention (4 months after intake). | Within 4 months of the intake assessment |
| Change in Fitness (Estimated Metabolic Equivalent of Task) |
| Measure | Description | Time Frame |
|---|---|---|
| Maintenance of Fitness Following Intervention (Peak Oxygen Uptake) | Changes in fitness level (peak oxygen uptake) will be measured from intervention completion until follow-up (8 months after intervention completion). | From completion of intervention (4 months) to follow-up (one-year). |
| Maintenance of Fitness Following Intervention (Estimated Metabolic Equivalent of Task) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Vermont Medical Center | Burlington | Vermont | 05405 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39037811 | Derived | Gaalema DE, Khadanga S, Savage PD, Yant B, Katz BR, DeSarno M, Ades PA. Improving Cardiac Rehabilitation Adherence in Patients With Lower Socioeconomic Status: A Randomized Clinical Trial. JAMA Intern Med. 2024 Sep 1;184(9):1095-1104. doi: 10.1001/jamainternmed.2024.3338. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Incentives | Patient earns incentives for completing cardiac rehabilitation sessions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions. |
| FG001 | Case Management | Patient is assigned a case manager while in hospital. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change. |
| FG002 | Incentives and Case Management | Patient receives both the Incentives and Case Management interventions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change. |
| FG003 | Usual Care | This control condition does not receive either intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Incentives | Patient earns incentives for completing cardiac rehabilitation sessions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions. |
| BG001 | Case Management |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Cardiac Rehabilitation Attendance | Number of cardiac rehabilitation sessions completed out of a possible 36 | Posted | Least Squares Mean | 95% Confidence Interval | sessions of CR | Within 4 months of the intake assessment |
|
1 Year
All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
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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 | Incentives | Patient earns incentives for completing cardiac rehabilitation sessions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (5.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA (5.0) | Systematic Assessment |
Study was powered for attendance rather than clinical outcomes; Study was conducted exclusively within Vermont, which may limit generalizability; Some assessment data are limited due to COVID-19 restrictions
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Diann Gaalema | University of Texas Medical Branch, Division of Cardiovascular Medicine | 409-772-1533 | digaalem@utmb.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 | Feb 10, 2022 | Sep 7, 2022 | Prot_SAP_004.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 16, 2021 | Mar 3, 2021 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D005298 | Fertility |
| D019090 | Case Management |
| ID | Term |
|---|---|
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
| D010347 | Patient Care Planning |
| D003191 | Comprehensive Health Care |
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| Case Management | Behavioral | A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change. |
|
Changes in fitness level (Metabolic Equivalent of Tasks) will be measured from intake to completion of the intervention (4 months after intake). |
| Within 4 months of the intake assessment |
| Change in Body Composition | Changes in waist measurement will be measured from intake to completion of the intervention (4 months after intake). | Within 4 months of the intake assessment |
| Changes in Smoking Status | Changes in smoking status will be measured from intake to completion of the intervention (4 months after intake). | Within 4 months of the intake assessment |
| Changes in Quality of Life - Cardiac Specific | Changes in perceived quality of life (MacNew) questionnaires will be measured from intake to completion of the intervention (4 months after intake). The MacNew Heart Disease Health-Related Quality of Life Questionnaire was used. Scores range from 1 to 7, with higher scores indicating better outcomes. | Within 4 months of the intake assessment |
| Changes in Quality of Life - Non-specific | Changes in perceived quality of life (EuroQoL) questionnaires will be measured from intake to completion of the intervention (4 months after intake). The Visual Analogue Scale of the EuroQol-5D-3L was used. Scores range from 0 to 100, with higher scores indicating better outcomes. | Within 4 months of the intake assessment |
| Changes in Mental Health | Changes in mental health (Adult Self-Report) questionnaires will be measured from intake to completion of the intervention (4 months after intake) using the Achenbach System of Empirically Based Assessment (ASEBA). T-scores are reported. A T-score of 50 indicates the population mean, and 10 is the standard deviation. Higher T-scores indicate worse outcomes. T-scores above 63 indicate clinically significant problems, and those between 60 and 63 fall within the borderline clinical range. | Within 4 months of the intake assessment |
| Changes in Depressive Symptoms | Changes in reported depressive symptoms "The Beck Depression Inventory (BDI)" will be measured from intake to completion of the intervention (4 months after intake). BDI results will be back transformed due to data being square root transformed. Scores range from 0 to 63, with higher scores indicating worse outcomes. | Within 4 months of the intake assessment |
| Changes in Executive Function (Delay Discounting) | Changes in Executive function (delay discounting) will be measured from intake to completion of the intervention (4 months after intake). A 5-trial adjusting delay discounting task was used to calculate k values, numerical representations of the rate of discounting. k values range from 0 to 0.5, with larger values indicating steeper discounting (more impulsivity; greater propensity to devalue delayed rewards in favor of more immediate outcomes). k values were log(10) transformed for analysis. Larger log transformed k values indicate steeper discounting. | Within 4 months of the intake assessment |
| Changes in Executive Function (DS) | Changes in Executive function (digit span) will be measured from intake to completion of the intervention (4 months after intake). The Digit Span subtest of the Wechsler Adult Intelligence Scale-IV (WAIS-IV) was used. Scores range from 1 to 19, with higher scores indicating worse outcomes. | Within 4 months of the intake assessment |
| Changes in Executive Function (Trail) | Changes in Executive function (Trail making task) will be measured from intake to completion of the intervention (4 months after intake). The Trail-Making subtest of the Delis-Kaplan Executive Function System (D-KEFS) was used. Scores range from 1 to 19, with higher scores indicating worse outcomes. | Within 4 months of the intake assessment |
| Changes in Executive Function (BRIEF) | Changes in self-reported Executive function problems (BRIEF) will be measured from intake to completion of the intervention (4 months after intake). The Global Executive Composite (GEC) of the Behavior Rating Inventory of Executive Function (BRIEF) was used. T-scores are reported. A T-score of 50 indicates the population mean, and 10 is the standard deviation. Higher T-scores indicate worse outcomes. T-scores above 65 indicate clinically significant problems. | Within 4 months of the intake assessment |
| Changes in Executive Function (SST) | Changes in Executive function (Stop Signal Task) will be measured from intake to completion of the intervention (4 months after intake). | Within 4 months of the intake assessment |
| Health Care Contacts | Combined measure of number of Emergency Department (ED) visits and overnight hospitalizations. | One year period starting at intake assessment. |
| Health Care Costs | Costs associated with combined Emergency Department (ED) visits and overnight hospitalizations. | One year period starting at intake assessment. |
Changes in fitness level (Estimated Metabolic Equivalent of Task) will be measured from intervention completion until follow-up (8 months after intervention completion). |
| From completion of intervention (4 months) to follow-up (one-year). |
| Maintenance of Waist Circumference Following Intervention. | Changes in waist circumference will be measured from intervention completion until follow-up (8 months after intervention completion). | From completion of intervention (4 months) to follow-up (one-year). |
| Maintenance of Smoking Status Following Intervention. | Changes in smoking status will be measured from intervention completion until follow-up (8 months after intervention completion). | From completion of intervention (4 months) to follow-up (one-year). |
| Maintenance of Quality of Life (Cardiac-specific) Following Intervention. | Changes in perceived quality of life (MacNew) questionnaires will be measured from intervention completion until follow-up (8 months after intervention completion). The MacNew Heart Disease Health-Related Quality of Life Questionnaire was used. Scores range from 1 to 7, with higher scores indicating better outcomes. | From completion of intervention (4 months) to follow-up (one-year). |
| Maintenance of Quality of Life (Noncardiac-specific) Following Intervention. | Changes in perceived quality of life (EuroQoL) questionnaires will be measured from intervention completion until follow-up (8 months after intervention completion). The Visual Analogue Scale of the EuroQol-5D-3L was used. Scores range from 0 to 100, with higher scores indicating better outcomes. | From completion of intervention (4 months) to follow-up (one-year). |
| Maintenance of Mental Health Following Intervention. | Changes in mental health (Adult Self-Report) questionnaires will be measured from intervention completion until follow-up (8 months after intervention completion) using the Achenbach System of Empirically Based Assessment (ASEBA). T-scores are reported. A T-score of 50 indicates the population mean, and 10 is the standard deviation. Higher T-scores indicate worse outcomes. T-scores above 63 indicate clinically significant problems, and those between 60 and 63 fall within the borderline clinical range. | From completion of intervention (4 months) to follow-up (one-year). |
| Maintenance of Depressive Symptoms Following Intervention. | Changes in reported depressive symptoms "The Beck Depression Inventory (BDI)" will be measured from intervention completion until follow-up (8 months after intervention completion). BDI results will be back transformed due to data being square root transformed. Scores range from 0 to 63, with higher scores indicating worse outcomes. | From completion of intervention (4 months) to follow-up (one-year). |
| Maintenance of Executive Function (Delay Discounting) Following Intervention. | Changes in Executive function (delay discounting) will be measured from intervention completion until follow-up (8 months after intervention completion). A 5-trial adjusting delay discounting task will be used to calculate k values, numerical representations of the rate of discounting. k values range from 0 to 0.5, with larger values indicating steeper discounting (more impulsivity; greater propensity to devalue delayed rewards in favor of more immediate outcomes). k values were log(10) transformed for analysis. Larger log transformed k values indicate steeper discounting. | From completion of intervention (4 months) to follow-up (one-year). |
| Maintenance of Executive Function (DS) Following Intervention. | Changes in Executive function (digit span) will be measured from intervention completion until follow-up (8 months after intervention completion). The Digit Span subtest of the Wechsler Adult Intelligence Scale-IV (WAIS-IV) was used. Scores range from 1 to 19, with higher scores indicating worse outcomes. | From completion of intervention (4 months) to follow-up (one-year). |
| Maintenance of Executive Function (BRIEF) Following Intervention. | Changes in self-reported Executive function problems (BRIEF) will be measured from intervention completion until follow-up (8 months after intervention completion). The Global Executive Composite (GEC) of the Behavior Rating Inventory of Executive Function (BRIEF) was used. T-scores are reported. A T-score of 50 indicates the population mean, and 10 is the standard deviation. Higher T-scores indicate worse outcomes. T-scores above 65 indicate clinically significant problems. | From completion of intervention (4 months) to follow-up (one-year). |
| Maintenance of Executive Function (SST) Following Intervention. | Changes in Executive function (stop signal task) will be measured from intervention completion until follow-up (8 months after intervention completion). | From completion of intervention (4 months) to follow-up (one-year). |
| Maintenance of Executive Function (Trail) Following Intervention. | Changes in Executive function (trail making task) will be measured from intervention completion until follow-up (8 months after intervention completion). The Trail-Making subtest of the Delis-Kaplan Executive Function System (D-KEFS) was used. Scores range from 1 to 19, with higher scores indicating worse outcomes. | From completion of intervention (4 months) to follow-up (one-year). |
| Cost-effectiveness | Cost-effectiveness of the intervention will be determined. Cost-effectiveness is a single outcome (cost per per quality-adjusted life year gained) that is calculated by integrating the cost of delivering the intervention, the cost to the patient of receiving the intervention, and the benefits both in quality of life and in reductions in healthcare utilization. | One year period starting at intake assessment. |
| Moved outside eligible area |
|
| Withdrawal by Subject |
|
Patient is assigned a case manager while in hospital. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change. |
| BG002 | Incentives and Case Management | Patient receives both the Incentives and Case Management interventions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change. |
| BG003 | Usual Care | This control condition does not receive either intervention. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Primary Diagnosis | Count of Participants | Participants |
|
| Currently Smoking | Count of Participants | Participants |
|
| Patient Health Questionnaire-2 | Count of Participants | Participants |
|
| Enrolled in Medicaid | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Region | Count of Participants | Participants |
|
| Peak Oxygen Uptake (Peak VO2) | Mean | Standard Deviation | milliliters per kilogram per minute |
|
| Estimated Metabolic Equivalent of Task (METs) | Mean | Standard Deviation | kilocalories per kilogram per hour |
|
| Waist Circumference | Mean | Standard Deviation | inches |
|
| Beck Depression Inventory | Depressive symptoms at baseline will be measured using the "The Beck Depression Inventory (BDI)." Scores range from 0 to 63, with higher scores indicating worse outcomes. | Mean | Standard Deviation | units on a scale |
|
| MacNew Heart Disease Health-related Quality of Life Questionnaire | Perceived quality of life will be measured at intake using the MacNew Heart Disease Health-Related Quality of Life Questionnaire. Scores range from 1 to 7, with higher scores indicating better outcomes. | Least Squares Mean | Standard Deviation | units on a scale |
|
| EuroQol Visual Analogue Scale | Perceived quality of life at intake will be measured using the Visual Analogue Scale of the EuroQol-5D-3L. Scores range from 0 to 100, with higher scores indicating better outcomes. | Mean | Standard Deviation | units on a scale |
|
| OG002 | Incentives and Case Management | Patient receives both the Incentives and Case Management interventions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change. |
| OG003 | Usual Care | This control condition does not receive either intervention. |
|
|
| Primary | Cardiac Rehabilitation Completion | Proportion of patients who complete 30+ sessions of cardiac rehabilitation | Posted | Count of Participants | Participants | Within 4 months of the intake assessment |
|
|
|
| Secondary | Change in Fitness (Peak Oxygen Uptake) | Changes in fitness level (peak oxygen uptake) will be measured from intake to completion of the intervention (4 months after intake). | Posted | Least Squares Mean | 95% Confidence Interval | milliliters per kilogram per minute | Within 4 months of the intake assessment |
|
|
|
| Secondary | Change in Fitness (Estimated Metabolic Equivalent of Task) | Changes in fitness level (Metabolic Equivalent of Tasks) will be measured from intake to completion of the intervention (4 months after intake). | Posted | Least Squares Mean | 95% Confidence Interval | milliliters per kilogram per minute | Within 4 months of the intake assessment |
|
|
|
| Secondary | Change in Body Composition | Changes in waist measurement will be measured from intake to completion of the intervention (4 months after intake). | Posted | Least Squares Mean | 95% Confidence Interval | inches | Within 4 months of the intake assessment |
|
|
|
| Secondary | Changes in Smoking Status | Changes in smoking status will be measured from intake to completion of the intervention (4 months after intake). | Overall number of participants analyzed represents the total number of participants from each arm of the study who completed this measure and for whom data were collected. | Posted | Count of Participants | Participants | Within 4 months of the intake assessment |
|
|
|
| Secondary | Changes in Quality of Life - Cardiac Specific | Changes in perceived quality of life (MacNew) questionnaires will be measured from intake to completion of the intervention (4 months after intake). The MacNew Heart Disease Health-Related Quality of Life Questionnaire was used. Scores range from 1 to 7, with higher scores indicating better outcomes. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Within 4 months of the intake assessment |
|
|
|
| Secondary | Changes in Quality of Life - Non-specific | Changes in perceived quality of life (EuroQoL) questionnaires will be measured from intake to completion of the intervention (4 months after intake). The Visual Analogue Scale of the EuroQol-5D-3L was used. Scores range from 0 to 100, with higher scores indicating better outcomes. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Within 4 months of the intake assessment |
|
|
|
| Secondary | Changes in Mental Health | Changes in mental health (Adult Self-Report) questionnaires will be measured from intake to completion of the intervention (4 months after intake) using the Achenbach System of Empirically Based Assessment (ASEBA). T-scores are reported. A T-score of 50 indicates the population mean, and 10 is the standard deviation. Higher T-scores indicate worse outcomes. T-scores above 63 indicate clinically significant problems, and those between 60 and 63 fall within the borderline clinical range. | Posted | Least Squares Mean | 95% Confidence Interval | T scores | Within 4 months of the intake assessment |
|
|
|
| Secondary | Changes in Depressive Symptoms | Changes in reported depressive symptoms "The Beck Depression Inventory (BDI)" will be measured from intake to completion of the intervention (4 months after intake). BDI results will be back transformed due to data being square root transformed. Scores range from 0 to 63, with higher scores indicating worse outcomes. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Within 4 months of the intake assessment |
|
|
|
| Secondary | Changes in Executive Function (Delay Discounting) | Changes in Executive function (delay discounting) will be measured from intake to completion of the intervention (4 months after intake). A 5-trial adjusting delay discounting task was used to calculate k values, numerical representations of the rate of discounting. k values range from 0 to 0.5, with larger values indicating steeper discounting (more impulsivity; greater propensity to devalue delayed rewards in favor of more immediate outcomes). k values were log(10) transformed for analysis. Larger log transformed k values indicate steeper discounting. | Posted | Least Squares Mean | 95% Confidence Interval | log of k | Within 4 months of the intake assessment |
|
|
|
| Secondary | Changes in Executive Function (DS) | Changes in Executive function (digit span) will be measured from intake to completion of the intervention (4 months after intake). The Digit Span subtest of the Wechsler Adult Intelligence Scale-IV (WAIS-IV) was used. Scores range from 1 to 19, with higher scores indicating worse outcomes. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Within 4 months of the intake assessment |
|
|
|
| Secondary | Changes in Executive Function (Trail) | Changes in Executive function (Trail making task) will be measured from intake to completion of the intervention (4 months after intake). The Trail-Making subtest of the Delis-Kaplan Executive Function System (D-KEFS) was used. Scores range from 1 to 19, with higher scores indicating worse outcomes. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Within 4 months of the intake assessment |
|
|
|
| Secondary | Changes in Executive Function (BRIEF) | Changes in self-reported Executive function problems (BRIEF) will be measured from intake to completion of the intervention (4 months after intake). The Global Executive Composite (GEC) of the Behavior Rating Inventory of Executive Function (BRIEF) was used. T-scores are reported. A T-score of 50 indicates the population mean, and 10 is the standard deviation. Higher T-scores indicate worse outcomes. T-scores above 65 indicate clinically significant problems. | Posted | Least Squares Mean | 95% Confidence Interval | T scores | Within 4 months of the intake assessment |
|
|
|
| Secondary | Changes in Executive Function (SST) | Changes in Executive function (Stop Signal Task) will be measured from intake to completion of the intervention (4 months after intake). | Posted | Least Squares Mean | 95% Confidence Interval | seconds | Within 4 months of the intake assessment |
|
|
|
| Secondary | Health Care Contacts | Combined measure of number of Emergency Department (ED) visits and overnight hospitalizations. | Posted | Number | number of visits | One year period starting at intake assessment. |
|
|
|
| Secondary | Health Care Costs | Costs associated with combined Emergency Department (ED) visits and overnight hospitalizations. | Not Posted | One year period starting at intake assessment. | Participants |
| Other Pre-specified | Maintenance of Fitness Following Intervention (Peak Oxygen Uptake) | Changes in fitness level (peak oxygen uptake) will be measured from intervention completion until follow-up (8 months after intervention completion). | Overall number of participants analyzed represents the total number of participants from each arm of the study who completed this measure and for whom data were collected. | Posted | Mean | Standard Deviation | milliliters per kilogram per minute | From completion of intervention (4 months) to follow-up (one-year). |
|
|
|
| Other Pre-specified | Maintenance of Fitness Following Intervention (Estimated Metabolic Equivalent of Task) | Changes in fitness level (Estimated Metabolic Equivalent of Task) will be measured from intervention completion until follow-up (8 months after intervention completion). | Overall number of participants analyzed represents the total number of participants from each arm of the study who completed this measure and for whom data were collected. | Posted | Mean | Standard Deviation | milliliters per kilogram per minute | From completion of intervention (4 months) to follow-up (one-year). |
|
|
|
| Other Pre-specified | Maintenance of Waist Circumference Following Intervention. | Changes in waist circumference will be measured from intervention completion until follow-up (8 months after intervention completion). | Overall number of participants analyzed represents the total number of participants from each arm of the study who completed this measure and for whom data were collected. | Posted | Mean | Standard Deviation | inches | From completion of intervention (4 months) to follow-up (one-year). |
|
|
|
| Other Pre-specified | Maintenance of Smoking Status Following Intervention. | Changes in smoking status will be measured from intervention completion until follow-up (8 months after intervention completion). | Overall number of participants analyzed represents the total number of participants from each arm of the study who completed this measure and for whom data were collected. | Posted | Count of Participants | Participants | From completion of intervention (4 months) to follow-up (one-year). |
|
|
|
| Other Pre-specified | Maintenance of Quality of Life (Cardiac-specific) Following Intervention. | Changes in perceived quality of life (MacNew) questionnaires will be measured from intervention completion until follow-up (8 months after intervention completion). The MacNew Heart Disease Health-Related Quality of Life Questionnaire was used. Scores range from 1 to 7, with higher scores indicating better outcomes. | Not Posted | From completion of intervention (4 months) to follow-up (one-year). | Participants |
| Other Pre-specified | Maintenance of Quality of Life (Noncardiac-specific) Following Intervention. | Changes in perceived quality of life (EuroQoL) questionnaires will be measured from intervention completion until follow-up (8 months after intervention completion). The Visual Analogue Scale of the EuroQol-5D-3L was used. Scores range from 0 to 100, with higher scores indicating better outcomes. | Not Posted | From completion of intervention (4 months) to follow-up (one-year). | Participants |
| Other Pre-specified | Maintenance of Mental Health Following Intervention. | Changes in mental health (Adult Self-Report) questionnaires will be measured from intervention completion until follow-up (8 months after intervention completion) using the Achenbach System of Empirically Based Assessment (ASEBA). T-scores are reported. A T-score of 50 indicates the population mean, and 10 is the standard deviation. Higher T-scores indicate worse outcomes. T-scores above 63 indicate clinically significant problems, and those between 60 and 63 fall within the borderline clinical range. | Not Posted | From completion of intervention (4 months) to follow-up (one-year). | Participants |
| Other Pre-specified | Maintenance of Depressive Symptoms Following Intervention. | Changes in reported depressive symptoms "The Beck Depression Inventory (BDI)" will be measured from intervention completion until follow-up (8 months after intervention completion). BDI results will be back transformed due to data being square root transformed. Scores range from 0 to 63, with higher scores indicating worse outcomes. | Not Posted | From completion of intervention (4 months) to follow-up (one-year). | Participants |
| Other Pre-specified | Maintenance of Executive Function (Delay Discounting) Following Intervention. | Changes in Executive function (delay discounting) will be measured from intervention completion until follow-up (8 months after intervention completion). A 5-trial adjusting delay discounting task will be used to calculate k values, numerical representations of the rate of discounting. k values range from 0 to 0.5, with larger values indicating steeper discounting (more impulsivity; greater propensity to devalue delayed rewards in favor of more immediate outcomes). k values were log(10) transformed for analysis. Larger log transformed k values indicate steeper discounting. | Not Posted | From completion of intervention (4 months) to follow-up (one-year). | Participants |
| Other Pre-specified | Maintenance of Executive Function (DS) Following Intervention. | Changes in Executive function (digit span) will be measured from intervention completion until follow-up (8 months after intervention completion). The Digit Span subtest of the Wechsler Adult Intelligence Scale-IV (WAIS-IV) was used. Scores range from 1 to 19, with higher scores indicating worse outcomes. | Not Posted | From completion of intervention (4 months) to follow-up (one-year). | Participants |
| Other Pre-specified | Maintenance of Executive Function (BRIEF) Following Intervention. | Changes in self-reported Executive function problems (BRIEF) will be measured from intervention completion until follow-up (8 months after intervention completion). The Global Executive Composite (GEC) of the Behavior Rating Inventory of Executive Function (BRIEF) was used. T-scores are reported. A T-score of 50 indicates the population mean, and 10 is the standard deviation. Higher T-scores indicate worse outcomes. T-scores above 65 indicate clinically significant problems. | Not Posted | From completion of intervention (4 months) to follow-up (one-year). | Participants |
| Other Pre-specified | Maintenance of Executive Function (SST) Following Intervention. | Changes in Executive function (stop signal task) will be measured from intervention completion until follow-up (8 months after intervention completion). | Not Posted | From completion of intervention (4 months) to follow-up (one-year). | Participants |
| Other Pre-specified | Maintenance of Executive Function (Trail) Following Intervention. | Changes in Executive function (trail making task) will be measured from intervention completion until follow-up (8 months after intervention completion). The Trail-Making subtest of the Delis-Kaplan Executive Function System (D-KEFS) was used. Scores range from 1 to 19, with higher scores indicating worse outcomes. | Not Posted | From completion of intervention (4 months) to follow-up (one-year). | Participants |
| Other Pre-specified | Cost-effectiveness | Cost-effectiveness of the intervention will be determined. Cost-effectiveness is a single outcome (cost per per quality-adjusted life year gained) that is calculated by integrating the cost of delivering the intervention, the cost to the patient of receiving the intervention, and the benefits both in quality of life and in reductions in healthcare utilization. | Not Posted | One year period starting at intake assessment. | Participants |
| 3 |
| 53 |
| 15 |
| 53 |
| 39 |
| 53 |
| EG001 | Case Management | Patient is assigned a case manager while in hospital. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change. | 5 | 51 | 25 | 51 | 42 | 51 |
| EG002 | Incentives and Case Management | Patient receives both the Incentives and Case Management interventions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change. | 3 | 52 | 20 | 52 | 42 | 52 |
| EG003 | Usual Care | This control condition does not receive either intervention. | 0 | 36 | 16 | 36 | 27 | 36 |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA (5.0) | Systematic Assessment |
|
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (5.0) | Systematic Assessment |
|
| Alcohol Intoxication | Injury, poisoning and procedural complications | MedDRA (5.0) | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA (5.0) | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (5.0) | Systematic Assessment |
|
| Cardiac Arrest | Cardiac disorders | MedDRA (5.0) | Systematic Assessment |
|
| Cardiac Disorders - Other | Cardiac disorders | MedDRA (5.0) | Systematic Assessment |
|
| Cardiogenic Shock | Cardiac disorders | MedDRA (5.0) | Systematic Assessment |
|
| Chest Pain - Cardiac | Cardiac disorders | MedDRA (5.0) | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA (5.0) | Systematic Assessment |
|
| Colorectal Cancer | Gastrointestinal disorders | MedDRA (5.0) | Systematic Assessment |
|
| Coronary Artery Bypass | Cardiac disorders | MedDRA (5.0) | Systematic Assessment |
|
| Death NOS | General disorders | MedDRA (5.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (5.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (5.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (5.0) | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA (5.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (5.0) | Systematic Assessment |
|
| Edema Limbs | General disorders | MedDRA (5.0) | Systematic Assessment |
|
| Failure to Thrive | General disorders | MedDRA (5.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (5.0) | Systematic Assessment |
|
| Gastric Hemorrhage | Gastrointestinal disorders | MedDRA (5.0) | Systematic Assessment |
|
| Gastrointestinal Disorders - Other | Gastrointestinal disorders | MedDRA (5.0) | Systematic Assessment |
|
| Heart Failure | Cardiac disorders | MedDRA (5.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA (5.0) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (5.0) | Systematic Assessment |
|
| Infections and Infestations - Other | Infections and infestations | MedDRA (5.0) | Systematic Assessment |
|
| Kidney Infection | Infections and infestations | MedDRA (5.0) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA (5.0) | Systematic Assessment |
|
| Mania | Psychiatric disorders | MedDRA (5.0) | Systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | MedDRA (5.0) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (5.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (5.0) | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (5.0) | Systematic Assessment |
|
| Psychosis | Psychiatric disorders | MedDRA (5.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (5.0) | Systematic Assessment |
|
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA (5.0) | Systematic Assessment |
|
| Stroke | Nervous system disorders | MedDRA (5.0) | Systematic Assessment |
|
| Suicidal Ideation | Psychiatric disorders | MedDRA (5.0) | Systematic Assessment |
|
| Surgical and Medical Procedures - Other | Surgical and medical procedures | MedDRA (5.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (5.0) | Systematic Assessment |
|
| Thromboembolic Event | Vascular disorders | MedDRA (5.0) | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA (5.0) | Systematic Assessment |
|
| Vaginal Infection | Infections and infestations | MedDRA (5.0) | Systematic Assessment |
|
| Ventricular Tachycardia | Cardiac disorders | MedDRA (5.0) | Systematic Assessment |
|
| Visceral Arterial Ischemia | Vascular disorders | MedDRA (5.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (5.0) | Systematic Assessment |
|
| Wound Complication | Injury, poisoning and procedural complications | MedDRA (5.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (5.0) | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA (5.0) | Systematic Assessment |
|
| Allergic reaction | Immune system disorders | MedDRA (5.0) | Systematic Assessment |
|
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | MedDRA (5.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | MedDRA (5.0) | Systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA (5.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (5.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (5.0) | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (5.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (5.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (5.0) | Systematic Assessment |
|
| Blood and lymphatic system disorders - Other | Blood and lymphatic system disorders | MedDRA (5.0) | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (5.0) | Systematic Assessment |
|
| Bruising | Injury, poisoning and procedural complications | MedDRA (5.0) | Systematic Assessment |
|
| Cardiac disorders - Other | Cardiac disorders | MedDRA (5.0) | Systematic Assessment |
|
| Chest pain - cardiac | Cardiac disorders | MedDRA (5.0) | Systematic Assessment |
|
| Chest Pressure | Cardiac disorders | MedDRA (5.0) | Systematic Assessment |
|
| Chest wall pain | Musculoskeletal and connective tissue disorders | MedDRA (5.0) | Systematic Assessment |
|
| Cholesterol high | Investigations | MedDRA (5.0) | Systematic Assessment |
|
| Colorectal cancer | Gastrointestinal disorders | MedDRA (5.0) | Systematic Assessment |
|
| Common Cold | Infections and infestations | MedDRA (5.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (5.0) | Systematic Assessment |
|
| COPD | Respiratory, thoracic and mediastinal disorders | MedDRA (5.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (5.0) | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA (5.0) | Systematic Assessment |
|
| Cystitis noninfective | Renal and urinary disorders | MedDRA (5.0) | Systematic Assessment |
|
| Death NOS | General disorders | MedDRA (5.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (5.0) | Systematic Assessment |
|
| Dental abscess | Infections and infestations | MedDRA (5.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (5.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (5.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (5.0) | Systematic Assessment |
|
| Domestic violence assault | Injury, poisoning and procedural complications | MedDRA (5.0) | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA (5.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (5.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (5.0) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (5.0) | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA (5.0) | Systematic Assessment |
|
| Edema | General disorders | MedDRA (5.0) | Systematic Assessment |
|
| Edema face | General disorders | MedDRA (5.0) | Systematic Assessment |
|
| Edema limbs | General disorders | MedDRA (5.0) | Systematic Assessment |
|
| Endocrine disorders - Other | Endocrine disorders | MedDRA (5.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (5.0) | Systematic Assessment |
|
| Eye disorders - Other | Eye disorders | MedDRA (5.0) | Systematic Assessment |
|
| Eye infection | Infections and infestations | MedDRA (5.0) | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA (5.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (5.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (5.0) | Systematic Assessment |
|
| Fever | General disorders | MedDRA (5.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (5.0) | Systematic Assessment |
|
| Flu like symptoms | General disorders | MedDRA (5.0) | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA (5.0) | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA (5.0) | Systematic Assessment |
|
| Gastrointestinal disorders - Other | Gastrointestinal disorders | MedDRA (5.0) | Systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | MedDRA (5.0) | Systematic Assessment |
|
| Gum infection | Infections and infestations | MedDRA (5.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (5.0) | Systematic Assessment |
|
| Hematoma | Vascular disorders | MedDRA (5.0) | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | MedDRA (5.0) | Systematic Assessment |
|
| Herpes Simplex | Reproductive system and breast disorders | MedDRA (5.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA (5.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (5.0) | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA (5.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | MedDRA (5.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (5.0) | Systematic Assessment |
|
| Infections and infestations - Other | Infections and infestations | MedDRA (5.0) | Systematic Assessment |
|
| Infective myositis | Infections and infestations | MedDRA (5.0) | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA (5.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (5.0) | Systematic Assessment |
|
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA (5.0) | Systematic Assessment |
|
| Kidney infection | Infections and infestations | MedDRA (5.0) | Systematic Assessment |
|
| Kidney Stones | Renal and urinary disorders | MedDRA (5.0) | Systematic Assessment |
|
| Left ventricular systolic dysfunction | Cardiac disorders | MedDRA (5.0) | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA (5.0) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA (5.0) | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA (5.0) | Systematic Assessment |
|
| Muscle cramp | Injury, poisoning and procedural complications | MedDRA (5.0) | Systematic Assessment |
|
| Musculoskeletal and connective tissue disord | Musculoskeletal and connective tissue disorders | MedDRA (5.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (5.0) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (5.0) | Systematic Assessment |
|
| Neoplasms benign, malignant and unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (5.0) | Systematic Assessment |
|
| Nightmares | Psychiatric disorders | MedDRA (5.0) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA (5.0) | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | MedDRA (5.0) | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA (5.0) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (5.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (5.0) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (5.0) | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | MedDRA (5.0) | Systematic Assessment |
|
| penile pain | Reproductive system and breast disorders | MedDRA (5.0) | Systematic Assessment |
|
| Peripheral ischemia | Vascular disorders | MedDRA (5.0) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (5.0) | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (5.0) | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA (5.0) | Systematic Assessment |
|
| Psychiatric disorders - Other | Psychiatric disorders | MedDRA (5.0) | Systematic Assessment |
|
| pulmonary edema | Respiratory, thoracic and mediastinal disorders | MedDRA (5.0) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (5.0) | Systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDRA (5.0) | Systematic Assessment |
|
| Rectal hemorrhage | Gastrointestinal disorders | MedDRA (5.0) | Systematic Assessment |
|
| Renal and urinary disorders - Other | Renal and urinary disorders | MedDRA (5.0) | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disord | Respiratory, thoracic and mediastinal disorders | MedDRA (5.0) | Systematic Assessment |
|
| Retinopathy | Eye disorders | MedDRA (5.0) | Systematic Assessment |
|
| Rotator cuff injury | Injury, poisoning and procedural complications | MedDRA (5.0) | Systematic Assessment |
|
| Scrotal pain | Reproductive system and breast disorders | MedDRA (5.0) | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA (5.0) | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA (5.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (5.0) | Systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Oth | Skin and subcutaneous tissue disorders | MedDRA (5.0) | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA (5.0) | Systematic Assessment |
|
| Skin ulceration | Skin and subcutaneous tissue disorders | MedDRA (5.0) | Systematic Assessment |
|
| Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (5.0) | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA (5.0) | Systematic Assessment |
|
| Surgical and medical procedures - Other | Surgical and medical procedures | MedDRA (5.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (5.0) | Systematic Assessment |
|
| Testicular pain | Reproductive system and breast disorders | MedDRA (5.0) | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA (5.0) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (5.0) | Systematic Assessment |
|
| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (5.0) | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | MedDRA (5.0) | Systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | MedDRA (5.0) | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA (5.0) | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA (5.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (5.0) | Systematic Assessment |
|
| Urinary tract pain | Renal and urinary disorders | MedDRA (5.0) | Systematic Assessment |
|
| Urostomy leak | Injury, poisoning and procedural complications | MedDRA (5.0) | Systematic Assessment |
|
| Vascular disorders - Other | Vascular disorders | MedDRA (5.0) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (5.0) | Systematic Assessment |
|
| Viral Upper Respiratory Infection | Infections and infestations | MedDRA (5.0) | Systematic Assessment |
|
| Vision decreased | Eye disorders | MedDRA (5.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (5.0) | Systematic Assessment |
|
| Weight gain | Investigations | MedDRA (5.0) | Systematic Assessment |
|
| Weight loss | Investigations | MedDRA (5.0) | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (5.0) | Systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | MedDRA (5.0) | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA (5.0) | Systematic Assessment |
|
| Wound Treatment | Injury, poisoning and procedural complications | MedDRA (5.0) | Systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA (5.0) | Systematic Assessment |
|
| Wrist Pain | Injury, poisoning and procedural complications | MedDRA (5.0) | Systematic Assessment |
|
Not provided
Not provided
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |