What this study is
Cardiac rehabilitation (CR) is an effective evidence-based intervention that improves outcomes in patients with acute coronary syndrome (ACS), but many eligible patients do not complete the program. A hybrid CR intervention that combines telehealth, home-based, and clinic-based components (TeleheartCR) may increase participation by addressing barriers to access while maintaining the functional capacity benefits of traditional CR. The purpose of this study is to conduct a randomized controlled trial comparing TeleheartCR with traditional clinic-based CR in patients with ACS to evaluate differences in program adherence and pre-to-post program change in functional capacity.
What's being tested
- Telehealth-enhanced Hybrid CR
Intervention · BEHAVIORAL
The telehealth-enhanced hybrid cardiac rehabilitation program combines in-person, clinic-based sessions with virtual, home-based sessions. Home-based sessions are delivered via synchronous video visits, with supervision by trained staff and real-time monitoring of physiological data (e.g., heart rate and blood pressure). The program delivers standard components of cardiac rehabilitation, including aerobic and resistance exercise training and patient education on heart-healthy lifestyle behaviors and risk factor management. Participants receive structured, program-specific orientation and training early in the program to support safe participation in virtual home-based sessions. The intervention is digitally enabled and incorporates an integrated system designed to guide and structure participation in program activities. The program includes up to 36 sessions, including a combination of clinic-based and home-based sessions.
- Traditional Cardiac Rehabilitation
Intervention · BEHAVIORAL
The traditional cardiac rehabilitation program is delivered in person through clinic-based sessions according to standard-of-care protocols. Sessions are supervised by trained staff and include aerobic and resistance exercise training, as well as patient education and counseling on heart-healthy lifestyle behaviors and risk factor management. The program includes up to 36 clinic-based sessions delivered according to standard-of-care practice.
Study details
- Official title
- Comparing a Novel Telehealth-enabled Hybrid Cardiac Rehabilitation Program to Clinic-based Cardiac Rehabilitation for Improving Patient Engagement and Functional Outcomes After ACS
- Sponsor
- Columbia University
- Conditions
- Acute Coronary Syndrome (ACS) · Myocardial Infarction
- Enrolling
- 250 people
- Starts
- 2026-05-19
- Est. completion
- 2029-05
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openColumbia University Irving Medical Center
New York, New York, United States
- Andrea T Duran, PhD · Contact212-342-4491atd2127@cumc.columbia.edu
- Andrea T Duran, PhD · Principal investigator
Recruiting
Study team
Sponsor
Columbia University
Study ID AAAV3946
Principal investigator
Andrea T. Duran, PhD
Columbia University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.