TeleheartCR vs. Clinic-Based Cardiac Rehabilitation After Acute Coronary Syndrome

NCT07541014 | Recruiting DMC

• 2 other identifiers: AAAV39465R01MD019189-02
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Proportion of targeted sessions completed (Program Adherence)

  Defined as the proportion of targeted cardiac rehabilitation (CR) sessions completed in each arm. Adherence will be calculated as the number of completed CR sessions divided by 36 (range: 0 to 1).

  During the cardiac rehabilitation program (up to 6 months)

• Change in 6-Minute Walk Test Distance

  Functional capacity will be assessed using the 6-minute walk test (6MWT), which measures the total distance walked in meters over six minutes. Change in functional capacity will be calculated as the difference between post-program and baseline 6MWT distance.

  Baseline and end of program (up to 6 months)

Secondary Outcomes (4)

• Mean Acceptability of Intervention Measure Score (Program Acceptability)

  End of program (up to 6 months)

• Mean Intervention Appropriateness Measure Score (Program Appropriateness)

  End of program (up to 6 months)

• Change in Health-Related Quality of Life Score

  Baseline and end of program (up to 6 months)

• Change in METs Achieved During Exercise Testing

  Baseline and end of program (up to 6 months)

Study Arms (2)

TeleheartCR

EXPERIMENTAL

Participants will receive Telehealth-enhanced Hybrid Cardiac Rehabilitation Program

Behavioral: Telehealth-enhanced Hybrid CR

Traditional CR

ACTIVE COMPARATOR

Participants will receive Traditional Clinic-based Cardiac Rehabilitation Program

Behavioral: Traditional Cardiac Rehabilitation

Interventions

Telehealth-enhanced Hybrid CR 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.

TeleheartCR

Traditional Cardiac Rehabilitation 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.

Traditional CR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify 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

Sponsors & Collaborators

• Columbia University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome; Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Andrea T. Duran, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea T Duran, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The principal investigator and senior statistician will remain blinded to treatment allocation until the database is locked. Participants, care providers, and outcome assessors will not be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medical Sciences

Model Details: Participants will be randomized in a 1:1 ratio to either a telehealth-enhanced hybrid cardiac rehabilitation program (TeleheartCR) or traditional clinic-based cardiac rehabilitation. This is a single-site, two-arm, parallel-group randomized controlled trial.

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 21, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: Data will be made available after publication of the primary study results and will remain available for at least 10 years thereafter.
• Access Criteria: De-identified data will be made publicly available via an open-access repository. No personally identifiable information will be shared.

Locations

US (1)