Telehealth-enhanced hybrid cardiac rehabilitation versus clinic-based rehab after an acute coronary syndrome
Comparing a Novel Telehealth-enabled Hybrid Cardiac Rehabilitation Program to Clinic-based Cardiac Rehabilitation for Improving Patient Engagement and Functional Outcomes After ACS
This trial tests whether TeleheartCR, a hybrid program combining telehealth, home, and clinic sessions, helps people who had an acute coronary syndrome complete cardiac rehab and improve their fitness as well as traditional clinic-based rehab.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT07541014 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial compares a TeleheartCR hybrid program (up to 36 sessions delivered via a mix of clinic-based and home/telehealth sessions, typically over about 12 weeks) with traditional clinic-based cardiac rehabilitation in patients who experienced an acute coronary syndrome. The study's primary implementation outcome is program adherence, and the primary effectiveness outcome is non-inferior pre-to-post change in functional capacity; secondary outcomes include quality of life and cardiorespiratory fitness. Participants are adults (≥18) within 12 months of ACS, able to read English or Spanish, and residing in New York State; some clinic visits at Columbia University Irving Medical Center are required. The protocol allows scheduling flexibility with up to 6 months post-enrollment to complete the program to accommodate clinical and personal needs.
Who should consider this trial
Good fit: Adults 18 or older who had an acute coronary syndrome within the past 12 months, are eligible for outpatient cardiac rehabilitation, can read English or Spanish, and live in New York State are ideal candidates.
Not a fit: People with high exercise-related cardiovascular risk, severe medical or psychiatric comorbidities, unsafe home environments, those who already started cardiac rehab, or those living outside New York State are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, TeleheartCR could increase access and adherence to cardiac rehabilitation while preserving the same functional and quality-of-life benefits as clinic-based programs.
How similar studies have performed: Previous studies of home-based or telehealth cardiac rehab have shown promising or non-inferior results for fitness and adherence, though hybrid programs focused on implementation and equity are less extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or older * Diagnosis of acute coronary syndrome within the past 12 months * Eligible for outpatient cardiac rehabilitation * Able to read and speak English or Spanish * Resides in New York State Exclusion Criteria: * Severe medical or psychiatric comorbidities that would prevent safe or adequate participation * High risk for adverse exercise-related cardiovascular events * Initiation of cardiac rehabilitation prior to enrollment (i.e., \>1 session completed) * Conditions that would interfere with safe or consistent participation in study procedures * Home environment or willingness not compatible with safe or adequate participation * Not expected to be available for follow-up during the study period * Current participation in another interventional clinical trial that may affect study outcomes
Where this trial is running
New York, New York
- Columbia University Irving Medical Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Andrea T. Duran, PhD — Columbia University
- Study coordinator: Andrea T Duran, PhD
- Email: atd2127@cumc.columbia.edu
- Phone: 212-342-4491
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.