Recruiting

TeleheartCR vs. Clinic-Based CR

Sponsor:

Columbia University

Code:

NCT07541014

Conditions

Acute Coronary Syndrome (ACS)

Myocardial Infarction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Telehealth-enhanced Hybrid CR

Traditional Cardiac Rehabilitation

Study Details

Brief summary:

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.

Conditions

Acute Coronary Syndrome (ACS)

Myocardial Infarction

Study ID

NCT07541014

Start date

May 19, 2026

Status verified date

May, 2026

Completion date

May, 2029

Anticipated

Primary completion date

May, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TeleheartCR

Participants will receive Telehealth-enhanced Hybrid Cardiac Rehabilitation Program

active comparator: Traditional CR

Participants will receive Traditional Clinic-based Cardiac Rehabilitation Program

Interventions

Telehealth-enhanced Hybrid CR

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

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.

Primary outcome measure

  • Proportion of targeted sessions completed (Program Adherence) [ Time Frame: During the cardiac rehabilitation program (up to 6 months) ]
  • Change in 6-Minute Walk Test Distance [ Time Frame: Baseline and end of program (up to 6 months) ]

Central Contacts and Locations

Central contacts

Andrea T Duran, PhD

212-342-4491atd2127@cumc.columbia.edu

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Andrea T Duran, PhD

212-342-4491atd2127@cumc.columbia.edu

Principal Investigator:

Andrea T Duran, PhD

More Information

Sponsor

Columbia University

Last update posted

Jun 3, 2026

Last verified

May, 2026

Keywords

  • Cardiac Rehabilitation
  • Hybrid Cardiac Rehabilitation
  • Virtual Cardiac Rehabilitation
  • Implementation Science
  • Adherence
  • Functional Capacity
  • Telehealth

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-06-03.