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| Name | Class |
|---|---|
| American Heart Association | OTHER |
| Apple Inc. | INDUSTRY |
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In this randomized clinical trial, the researchers are investigating whether a multi-component virtual/hybrid cardiac rehabilitation program will improve functional status, cholesterol level, overall cardiovascular health, individual risk factors, quality of life and mental health for patients who have recently been diagnosed with myocardial infarction, received a coronary stent, underwent heart surgery or catheter-based valve replacement, as compared to traditional, center-based cardiac rehabilitation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | Experimental | Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation. |
|
| Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) | No Intervention | Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corrie Hybrid Cardiac Rehabilitation Program | Combination Product | The Corrie Hybrid Cardiac Rehabilitation Program is a multi-component intervention. It consists of the Corrie smartphone app for cardiovascular health optimization which is paired with wristband device (Apple Watch or Fitbit), Bluetooth-enabled Omron blood pressure monitor and exercise resistance bands. The program also includes individualized treatment plan development, setting health goals and communication with trained Corrie Health Coach. Furthermore, the intervention includes motivational text messages sent to participants throughout the study to aid with risk factor modification. |
| Measure | Description | Time Frame |
|---|---|---|
| 6-minute Walking Distance (Meters) | Mean difference in 6 minute walk distance, between Intervention and Control groups, as measured at final study visit occurring at 12 weeks after randomization. | 12 weeks after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Cardiovascular Health Metric for Secondary Prevention | The cardiovascular health metric for secondary prevention (adapted from American Heart Association's Life Simple 7). The score ranges from 0 to 14 with higher score indicating better cardiovascular health. | 12 weeks after randomization |
| Blood Pressure (mmHg) |
| Measure | Description | Time Frame |
|---|---|---|
| Depression as Assessed by the Patient Health Questionnaire 8 | The difference in depressive symptoms as measured by Patient Health Questionnaire 8 (PHQ 8): The 8 item questionnaire administered at 12 weeks with the following scoring system: Score range 0-24. A score of 10 or greater is considered major depression, 20 or more is severe major depression. Note, as an exploratory outcome, only a subgroup of participants responded to this survey request. |
Inclusion Criteria:
Exclusion Criteria
Non-English speaking
Symptomatic severe aortic stenosis or other severe valvular disease
Physical disability that would preclude safe and adequate exercise performance
Hypertrophic obstructive cardiomyopathy with peak resting left ventricular outflow gradient of >25 mmHg
Known aortic dissection
Severe resting arterial hypertension (Systolic blood pressure >200 mmHg or diastolic BP >110mmHg) at baseline assessment
Mental impairment leading to inability to cooperate with study procedures
Untreated high degree atrioventricular block
Atrial fibrillation with uncontrolled ventricular rate (Heart rate >110 at rest) at baseline assessment
History of cardiac arrest or sudden death
Myocardial infarction or cardiac surgery complications with cardiogenic shock and/or congestive heart failure and/or signs/symptoms of post-procedure ischemia
Left ventricular ejection fraction <40%
History of Clinically significant depression
Visual or hearing impairment which precludes the use of the intervention
Presence of cardiac defibrillator
Incomplete revascularization procedure
History of one or more episodes of falls in the last year
Pregnancy
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| Name | Affiliation | Role |
|---|---|---|
| Lena Mathews, MD, MHS | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38226511 | Background | Isakadze N, Kim CH, Marvel FA, Ding J, MacFarlane Z, Gao Y, Spaulding EM, Stewart KJ, Nimbalkar M, Bush A, Broderick A, Gallagher J, Molello N, Commodore-Mensah Y, Michos ED, Dunn P, Hanley DF, McBee N, Martin SS, Mathews L. Rationale and Design of the mTECH-Rehab Randomized Controlled Trial: Impact of a Mobile Technology Enabled Corrie Cardiac Rehabilitation Program on Functional Status and Cardiovascular Health. J Am Heart Assoc. 2024 Jan 16;13(2):e030654. doi: 10.1161/JAHA.123.030654. Epub 2024 Jan 16. |
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De-identified, aggregate level results, including primary and secondary outcomes, and the data dictionary will be shared through clinicaltrials.gov. Study documents (study protocol, statistical analysis plan, informed consent form, analytic code) will also be shared upon request.
IPD will be made available upon request for up to 3 years from the study completion date (to 10/14/2027).
Researchers must submit a letter of intention and formal data request to the mTECH-Rehab principal investigator, who will review the request with the core study team and grant approval based on evaluation of merit.
Drop-out (pre-randomization/run-in) - 57. (Lost to follow up - 32. Developed exclusion criteria -10. Withdrew consent - 8. Financial reason - 5. Unable to undergo safety evaluation - 2). 259 Enrolled. 202 participants randomized.
Assessed for eligibility: 6,170; Met eligibility criteria: 1,252; Met exclusion criteria: 4,918; Excluded: 993 (Declined to participate: 710, Unable to be contacted: 283).
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| ID | Title | Description |
|---|---|---|
| FG000 | Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation. |
| FG001 | Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) | Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation. |
| BG001 | Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Composite Cardiovascular Health Metric for Secondary Prevention | The cardiovascular health metric for secondary prevention (adapted from American Heart Association's Life Simple 7). The score ranges from 0 to 14 with higher score indicating better cardiovascular health. | Posted | Mean | Standard Deviation | Score on a scale | 12 weeks after randomization |
|
From enrollment until end of follow-up at 12 weeks after randomization
Reported mortality (by electronic health record review or family report), serious adverse events (by electronic health record review or family report), or minor events (by patient report)
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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 | Corrie Hybrid Cardiac Rehabilitation Program (Intervention Group) | Receives Corrie Virtual Cardiac Rehabilitation Program along with option to continue traditional, center-based cardiac rehabilitation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute decompensated heart failure | Cardiac disorders | Non-systematic Assessment | Acute decompensated heart failure requiring hospitalization |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Symptoms during 6 minute walk test | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Patient reporting significant symptoms during 6 minute walk test requiring early termination or modification of 6MWT protocol |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lena Mathews, MD MHS | Johns Hopkins University | 410-502-0469 | lmathew6@jhmi.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 | Oct 9, 2024 | Oct 14, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 27, 2023 | Oct 14, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D054059 | Coronary Occlusion |
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
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|
Systolic blood pressure and Diastolic blood pressure |
| 12 weeks after randomization |
| Low Density Lipoprotein - Cholesterol (LDL-C) | LDL cholesterol level (in mg/dl) measured through blood sample drawn at 12 week follow up visit | 12 weeks after randomization |
| Glycosylated Hemoglobin (HbA1c) | Glycosylated hemoglobin (HbA1c) level (%) measured through blood sample drawn at 12 week follow up visit | 12 weeks after randomization |
| Body Mass Index (kg/m^2) | BMI = weight (kg) / height in meters squared (m^2). Weight and height measured by study staff at study visit. | 12 weeks after randomization |
| Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10 | Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10: The 10-item patient-reported questionnaire administered at 12 weeks follow up in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient. | 12 weeks after randomization |
| Blood Pressure Control | Blood pressure control (Cardiovascular secondary health metric component). Ideal (SBP <130 mmHg and DBP <90 mmHg). Intermediate (SBP 130-139 mmHg or DBP 80-89 mmHg). Poor (SBP ≥140 mmHg or DBP ≥90 mmHg). | 12 weeks after randomization |
| Cholesterol (LDL-C) Control | Cholesterol (LDL-C) control (Cardiovascular secondary health metric component). Ideal (LDL-C <70mg/dL). Intermediate (LDL-C 70-99 mg/dL). Poor (LDL-C ≥100mg/dL) | 12 weeks after randomization |
| Diabetes Control | Diabetes (HbA1c) control (Cardiovascular secondary health metric component). Ideal (HbA1c <7% for diabetic, <5.7% for non-diabetic). Intermediate (HbA1c 7.0-7.9% for diabetic, 5.0-5.9% for non-diabetic). Poor (HbA1c ≥8% for diabetic, ≥6.5% for non-diabetic). | 12 weeks after randomization |
| Weight (BMI) Categories | Weight (BMI) categories (Cardiovascular secondary health metric component). Ideal (BMI <25 kg/m^2). Intermediate (BMI 25-29 kg/m^2). Poor (BMI ≥ 30 kg/m^2). | 12 weeks after randomization |
| Physical Activity Categories | Physical activity categories (Cardiovascular secondary health metric component). Ideal (≥150 min/wk moderate physical activity, ≥75 min/wk vigorous physical activity). Intermediate (1-149 min/wk moderate physical activity, 1-74 min/wk vigorous physical activity). Poor (No regular exercise). | 12 weeks after randomization |
| Diet Categories | Diet categories (Cardiovascular secondary health metric component). Ideal (Rate Your Plate score 64-81). Intermediate (Rate Your Plate score 46-63). Poor (Rate Your Plate score 27-45). | 12 weeks after randomization |
| Tobacco Use | Tobacco use categories (Cardiovascular secondary health metric component). Ideal (never). Intermediate (Former smoker). Poor (Recent/Current smoker). | 12 weeks after randomization |
| Cardiac Rehabilitation Engagement | Cardiac rehabilitation engagement as measured by number of participants who attended the sessions per category. Grouped by Healthcare Effectiveness Data and Information Set (HEDIS) categories: Initiation (0-12 sessions attended), Engagement 1 (13-24 sessions attended), Engagement 2 (25-36 sessions attended). | 12 weeks after randomization |
| 12 weeks after randomization |
| Anxiety as Assessed by the Generalized Anxiety Disorder 7 | The difference in anxiety level as measured by Generalized Anxiety Disorder 7 (GAD 7): The 7-item questionnaire administered at 12 weeks follow up with the following scoring system. Each item is assigned scores of 0, 1, 2, and 3 to the response categories. GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety. | 12 weeks after randomization |
| Stress as Assessed by the Perceived Stress Scale-10 | The difference in stress level as measured by Perceived Stress Scale (PSS -10): The 10 item questionnaire administered at 12 weeks follow up. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. | 12 weeks after randomization |
| Health Literacy as Assessed by the (e) Health Literacy Scale (eHEALS) | The difference in Health Literacy as measured by The (e) Health Literacy Scale (eHEALS): The 8 item scale administered at 12 weeks follow up. Total scores of the eHEALS range from 8 to 40, with higher scores representing higher self-perceived (e) Health literacy. | 12 weeks after randomization |
| Patient Activation as Assessed by the Patient Activation Measure 10 | The difference in patient activation as measured by Patient Activation Measure 10 (PAM 10): The 10-item five-point Likert scale for assessing patient activation at 12 weeks follow up, indicating whether the patient possesses the necessary knowledge, skills, and confidence needed for self-care. The total score reference range is from 0 to 100, where higher scores indicate greater patient activation and ability for self-care. | 12 weeks after randomization |
| User Engagement as Assessed by the Number of App Interactions (Intervention Group Only) | Number of interactions in the smartphone app per participant, collected via the Corrie Health Platform User Analytics at 12 weeks follow up (only assessed in intervention arm). | 12 weeks after randomization |
Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Cardiac Rehabilitation Indication (Disease Category + Treatment Modality) | AMI: Acute myocardial infarction, CAD: Coronary artery disease, CABG: Coronary artery bypass grafting surgery, PCI: Percutaneous coronary intervention, TAVR: Transcatheter aortic valve replacement, VHD: Valvular heart disease | Count of Participants | Participants |
|
| Clinical History | Participants may fit into more than one category | Count of Participants | Participants | No |
|
| Cardiac Rehabilitation Indication (Disease Category) | AMI: Acute myocardial infarction, CAD: Coronary artery disease, CABG: Coronary artery bypass grafting surgery, PCI: Percutaneous coronary intervention, TAVR: Transcatheter aortic valve replacement, VHD: Valvular heart disease | Count of Participants | Participants |
|
| Blood Pressure (mmHg) | Mean | Standard Deviation | mmHg |
|
| Heart Rate (beats per minute) | Mean | Standard Deviation | beats per minute |
|
| Weight (kilograms) | Mean | Standard Deviation | kilograms |
|
| Body Mass Index (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
|
| Left Ventricular ejection fraction (LVEF) | Mean | Standard Deviation | Percentage of LVEF |
|
|
|
|
| Secondary | Blood Pressure (mmHg) | Systolic blood pressure and Diastolic blood pressure | Posted | Mean | Standard Deviation | mmHg | 12 weeks after randomization |
|
|
|
|
| Secondary | Low Density Lipoprotein - Cholesterol (LDL-C) | LDL cholesterol level (in mg/dl) measured through blood sample drawn at 12 week follow up visit | Posted | Mean | Standard Deviation | mg/dL | 12 weeks after randomization |
|
|
|
|
| Secondary | Glycosylated Hemoglobin (HbA1c) | Glycosylated hemoglobin (HbA1c) level (%) measured through blood sample drawn at 12 week follow up visit | Posted | Mean | Standard Deviation | percentage of glycated hemoglobin | 12 weeks after randomization |
|
|
|
|
| Secondary | Body Mass Index (kg/m^2) | BMI = weight (kg) / height in meters squared (m^2). Weight and height measured by study staff at study visit. | Posted | Mean | Standard Deviation | kg/m^2 | 12 weeks after randomization |
|
|
|
|
| Secondary | Quality of Life as Assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10 | Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10: The 10-item patient-reported questionnaire administered at 12 weeks follow up in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient. | Posted | Mean | Standard Deviation | t-score | 12 weeks after randomization |
|
|
|
|
| Secondary | Blood Pressure Control | Blood pressure control (Cardiovascular secondary health metric component). Ideal (SBP <130 mmHg and DBP <90 mmHg). Intermediate (SBP 130-139 mmHg or DBP 80-89 mmHg). Poor (SBP ≥140 mmHg or DBP ≥90 mmHg). | Posted | Count of Participants | Participants | 12 weeks after randomization |
|
|
|
|
| Secondary | Cholesterol (LDL-C) Control | Cholesterol (LDL-C) control (Cardiovascular secondary health metric component). Ideal (LDL-C <70mg/dL). Intermediate (LDL-C 70-99 mg/dL). Poor (LDL-C ≥100mg/dL) | Posted | Count of Participants | Participants | 12 weeks after randomization |
|
|
|
|
| Secondary | Diabetes Control | Diabetes (HbA1c) control (Cardiovascular secondary health metric component). Ideal (HbA1c <7% for diabetic, <5.7% for non-diabetic). Intermediate (HbA1c 7.0-7.9% for diabetic, 5.0-5.9% for non-diabetic). Poor (HbA1c ≥8% for diabetic, ≥6.5% for non-diabetic). | Posted | Count of Participants | Participants | 12 weeks after randomization |
|
|
|
|
| Secondary | Weight (BMI) Categories | Weight (BMI) categories (Cardiovascular secondary health metric component). Ideal (BMI <25 kg/m^2). Intermediate (BMI 25-29 kg/m^2). Poor (BMI ≥ 30 kg/m^2). | Posted | Count of Participants | Participants | 12 weeks after randomization |
|
|
|
|
| Secondary | Physical Activity Categories | Physical activity categories (Cardiovascular secondary health metric component). Ideal (≥150 min/wk moderate physical activity, ≥75 min/wk vigorous physical activity). Intermediate (1-149 min/wk moderate physical activity, 1-74 min/wk vigorous physical activity). Poor (No regular exercise). | Posted | Count of Participants | Participants | 12 weeks after randomization |
|
|
|
|
| Secondary | Diet Categories | Diet categories (Cardiovascular secondary health metric component). Ideal (Rate Your Plate score 64-81). Intermediate (Rate Your Plate score 46-63). Poor (Rate Your Plate score 27-45). | Posted | Count of Participants | Participants | 12 weeks after randomization |
|
|
|
|
| Secondary | Tobacco Use | Tobacco use categories (Cardiovascular secondary health metric component). Ideal (never). Intermediate (Former smoker). Poor (Recent/Current smoker). | Posted | Count of Participants | Participants | 12 weeks after randomization |
|
|
|
|
| Secondary | Cardiac Rehabilitation Engagement | Cardiac rehabilitation engagement as measured by number of participants who attended the sessions per category. Grouped by Healthcare Effectiveness Data and Information Set (HEDIS) categories: Initiation (0-12 sessions attended), Engagement 1 (13-24 sessions attended), Engagement 2 (25-36 sessions attended). | Posted | Count of Participants | Participants | 12 weeks after randomization |
|
|
|
|
| Other Pre-specified | Depression as Assessed by the Patient Health Questionnaire 8 | The difference in depressive symptoms as measured by Patient Health Questionnaire 8 (PHQ 8): The 8 item questionnaire administered at 12 weeks with the following scoring system: Score range 0-24. A score of 10 or greater is considered major depression, 20 or more is severe major depression. Note, as an exploratory outcome, only a subgroup of participants responded to this survey request. | Note, as an exploratory outcome, only a subgroup of randomized study participants responded to this survey request. | Posted | Median | Inter-Quartile Range | score on a scale | 12 weeks after randomization |
|
|
|
| Other Pre-specified | Anxiety as Assessed by the Generalized Anxiety Disorder 7 | The difference in anxiety level as measured by Generalized Anxiety Disorder 7 (GAD 7): The 7-item questionnaire administered at 12 weeks follow up with the following scoring system. Each item is assigned scores of 0, 1, 2, and 3 to the response categories. GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety. | Note, as an exploratory outcome, only a subgroup of randomized study participants responded to this survey request. | Posted | Median | Inter-Quartile Range | score on a scale | 12 weeks after randomization |
|
|
|
| Other Pre-specified | Stress as Assessed by the Perceived Stress Scale-10 | The difference in stress level as measured by Perceived Stress Scale (PSS -10): The 10 item questionnaire administered at 12 weeks follow up. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. | Note, as an exploratory outcome, only a subgroup of randomized study participants responded to this survey request. | Posted | Mean | Standard Deviation | Score on a scale | 12 weeks after randomization |
|
|
|
| Other Pre-specified | Health Literacy as Assessed by the (e) Health Literacy Scale (eHEALS) | The difference in Health Literacy as measured by The (e) Health Literacy Scale (eHEALS): The 8 item scale administered at 12 weeks follow up. Total scores of the eHEALS range from 8 to 40, with higher scores representing higher self-perceived (e) Health literacy. | Note, as an exploratory outcome, only a subgroup of randomized study participants responded to this survey request. | Posted | Mean | Standard Deviation | Score on a scale | 12 weeks after randomization |
|
|
|
| Other Pre-specified | Patient Activation as Assessed by the Patient Activation Measure 10 | The difference in patient activation as measured by Patient Activation Measure 10 (PAM 10): The 10-item five-point Likert scale for assessing patient activation at 12 weeks follow up, indicating whether the patient possesses the necessary knowledge, skills, and confidence needed for self-care. The total score reference range is from 0 to 100, where higher scores indicate greater patient activation and ability for self-care. | Note, as an exploratory outcome, only a subgroup of randomized study participants responded to this survey request. | Posted | Mean | Standard Deviation | Score on a scale | 12 weeks after randomization |
|
|
|
| Primary | 6-minute Walking Distance (Meters) | Mean difference in 6 minute walk distance, between Intervention and Control groups, as measured at final study visit occurring at 12 weeks after randomization. | Posted | Mean | Standard Deviation | meters | 12 weeks after randomization |
|
|
|
|
| Other Pre-specified | User Engagement as Assessed by the Number of App Interactions (Intervention Group Only) | Number of interactions in the smartphone app per participant, collected via the Corrie Health Platform User Analytics at 12 weeks follow up (only assessed in intervention arm). | Posted | Mean | Standard Deviation | app interactions | 12 weeks after randomization |
|
|
|
| 0 |
| 101 |
| 2 |
| 101 |
| 4 |
| 101 |
| EG001 | Facilitated Center-Based Cardiac Rehabilitation Program (Control Group) | Receives traditional, center-based cardiac rehabilitation. The study team will help facilitate the logistics of receiving center-based cardiac rehabilitation, including proper referrals. | 0 | 101 | 9 | 101 | 2 | 101 |
|
| Atrial fibrillation with rapid ventricular response | Cardiac disorders | Non-systematic Assessment | Atrial fibrillation with rapid ventricular response requiring hospitalization |
|
| ST-elevation myocardial infarction (STEMI) due to bypass graft occlusion | Cardiac disorders | Non-systematic Assessment | ST-elevation myocardial infarction (STEMI) due to bypass graft occlusion requiring hospitalization |
|
| Stress cardiomyopathy | Cardiac disorders | Non-systematic Assessment | Stress cardiomyopathy requiring hospitalization |
|
| Syncope | Nervous system disorders | Non-systematic Assessment | Syncope event requiring hospitalization |
|
| Chest pain (non-cardiac) | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Non-cardiac chest pain requiring hospitalization |
|
| Gastrointestinal disorder | Gastrointestinal disorders | Non-systematic Assessment | Gastrointestinal disorder requiring hospitalization |
|
| Infection | Infections and infestations | Non-systematic Assessment | Infection requiring hospitalization |
|
|
| Chest pain at home (non-cardiac) | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Chest pain at home, deemed non-cardiac etiology and not requiring hospitalization |
|
| Pain from wearable device | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Significant pain from wearable device, precluding meaning use of technology and hybrid CR intervention |
|
| Delayed blood sample processing | Product Issues | Non-systematic Assessment | Delayed blood sample processing for lab sample collected during final study visit |
|
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| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| 0.25 |
| Superiority |
| 0.71 |
| Superiority |
| Poor |
|
| Poor |
|
| Poor |
|
| Poor |
|
| Poor |
|
| Poor |
|
| Engagement 2 (25-36 sessions attended) |
|
|
| App interaction for medication taken event |
|
| App interaction for weight check event |
|
| App interaction for mood check event |
|
| App interaction for step count check event |
|
| App interaction for education event |
|