The Improving ATTENDance to Cardiac Rehabilitation Trial

Study Overview
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Brief Summary
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The benefits of cardiac rehabilitation are well known. However, despite center based cardiac rehabilitation (CBCR) representing guideline-based care for patients with cardiovascular disease, most patients do not complete the maximum number of sessions allowed by third party insurance payers. As such, many patients may not be receiving the full clinical benefit ascribed to CR. This study will assess the efficacy of an innovative approach to CR delivery on attendance by combining both center-based and remote- or home-based CR sessions. The intervention group combines center-based CR and remote-/home-based CR and is tailored to the individual needs of each patient, accomplished with the assistance of an easy-to-access telecommunications methodology (telemedicine)

Official Title
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The Improving ATTENDance to Cardiac Rehabilitation Trial

Conditions
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Myocardial Infarction, Heart Failure, Heart Valve Diseases, Cardiac Event, Angina Pectoris, Coronary Artery Disease

Intervention / Treatment
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* Behavioral: HYCR
* Behavioral: CBCR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has agreed to participate in CR and has experienced a cardiac event (myocardial infraction, coronary revascularization, heart valve surgery, or cardiac transplant in the past 6 months; diagnosed with chronic, stable AHA/ACC stage B or C heart failure or Canadian class 0-2 stable angina pectoris) Lives in or plans to remain in the greater Detroit, MI area for the next year Age 18-85 years of age Agrees to attend at least one CBCR session Agrees to scheduling at least 2, up to 3, CR sessions (either CBCR or HYCR)/wk Has demonstrated to research staff their ability to access and connect to the internet via smart phone or tablet and already has access to satisfactory home- or community-based exercise equipment Exclusion Criteria: Received a left ventricular assist device, receiving continuous inotropic support (e.g., milrinone), or undergoing hemodialysis Angina at rest or with a low functional capacity (< 2 METs) Advanced cancer, advanced risk for falling, limiting cognitive impairment, or other advanced disorder that limits participation in CR Advanced risk for falling will be assessed by 5X sit-to-stand test, with a cut-off score of >15 seconds Cognitive assessment will be completed using the Mini-Cog instrument, with a cut-off score < 3 used to exclude potential subjects. Severe arrhythmia unless adequately treated (e.g., implantable cardiac defibrillator) Pregnant or plan to become pregnant in the next year. Major cardiovascular procedure or hospitalization planned in the next 6 months Less than 12 month life expectancy Participation in another clinical trial that interferes with iATTEND participation, follow-up, data collection, exercise capacity or quality of life.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hybrid Cardiac Rehabilitation (HYCR)<br> | Behavioral: HYCR<br>* This group involves a hybrid design, with the frequency of center based cardiac rehabilitation (CBCR) visits and HYCR visits individualized and modified based on the subject's personal preferences and their family, transportation and work constraints. Patients in HYCR will engage in at least one CBCR visit. Patients will have the video app loaded to their smart phone or tablet (or that of a willing to assist family member or friend). HYCR patients receive a chest strap/wrist heart rate device to document HR before, during, and/or after exercise during the TM session. Program education for patients in HYCR will be delivered using the twenty-eight, 7-15 min audio PDF's that are free to access from the Health System's web site.<br>|
| Active Comparator: Center Based cardiac Rehabilitation (CBCR)<br> | Behavioral: CBCR<br>* This group will attend 2-3 sessions of cardiac rehabilitation per week at the investigator's Detroit location. Program education for patients in CBCR will be delivered during eight. 1 hour education lectures taught by staff (exercise physiologists and registered dieticians).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of CR sessions completed within 6 months will be significantly greater in patients randomized to HYCR vs. patients randomized to traditional CBCR (usual care). |  | Baseline to 6 months | 
| The percentage of patients completing 36 CR sessions within 6 months will be significantly greater among patients randomized to the HYCR program vs. patients randomized to the CBCR program. |  | Baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The improvement in exercise capacity, as measured by distance walked during the six min walk (6MW) test, in patients randomized to HYCR will be equivalent (not inferior) to patients randomized to CBCR. |  | Baseline to 6 months | 
| The improvement in exercise capacity, as measured by peak oxygen uptake (VO2), in patients randomized to HYCR will be equivalent (not inferior) to patients randomized to CBCR. |  | Baseline to 6 months | 
| The improvement in quality of life (QOL), as measured by the Short Form Health Survey-12, in patients randomized to HYCR will be equivalent (not inferior) to patients randomized to CBCR. |  | Baseline to 6 months |