N/A
N=282
The Improving ATTENDance to Cardiac Rehabilitation Trial
Myocardial Infarction · Heart Failure · Heart Valve Diseases · Cardiac Event · Angina Pectoris
Bottom Line
View on ClinicalTrials.gov: NCT03646760 ↗Enrolled (actual)
282
Serious AEs
0.4%
Results posted
Jul 2025
Primary outcome: Primary: Number of CR Sessions Completed Within 6 Months in Patients Randomized to HYCR vs. Patients Randomized to Traditional CBCR (Usual Care). — 28.7; 27.6 Number of cardiac rehab sessions
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HYCR (Behavioral); CBCR (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Henry Ford Health System
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of CR Sessions Completed Within 6 Months in Patients Randomized to HYCR vs. Patients Randomized to Traditional CBCR (Usual Care). |
28.7; 27.6 | — |
| PRIMARY Percentage of Patients Completing 36 CR Sessions Within 6 Months Among Patients Randomized to the HYCR Program vs. Patients Randomized to the CBCR Program. |
58.5; 50.7 | — |
| SECONDARY Improvement in Exercise Capacity, as Measured by Distance Walked During the Six Min Walk (6MW) Test, in Patients Randomized to HYCR vs Patients Randomized to CBCR. |
46; 50 | — |
| SECONDARY Improvement in Exercise Capacity, as Measured by Peak Oxygen Uptake (VO2), in Patients Randomized to HYCR vs Patients Randomized to CBCR. |
2.3; 1.9 | — |
| SECONDARY Improvement in Quality of Life (QOL), as Measured by the Total Score for Dartmouth COOP, in Patients Randomized to HYCR vs Patients Randomized to CBCR. |
-3.9; -3.4 | — |
Summary
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)
Eligibility Criteria
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 ( 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.
Data sourced from ClinicalTrials.gov (NCT03646760). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.