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

May 30, 2026 updated by: Andrea Duran, Columbia University

Comparing a Novel Telehealth-enabled Hybrid Cardiac Rehabilitation Program to Clinic-based Cardiac Rehabilitation for Improving Patient Engagement and Functional Outcomes After ACS

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Over 1 million patients are hospitalized annually in the United States for an acute coronary syndrome (ACS; myocardial infarction or unstable angina). Accordingly, CR is recognized as a Class I, Level A recommendation for secondary prevention in ACS survivors. Yet less than a quarter of eligible cardiac patients utilize CR in the US. Even among patients who initiate CR, fewer attend all prescribed CR sessions, with lower rates observed among those with low socioeconomic status (SES), and racial and ethnic minoritized groups. Low and disparate CR adherence harms patients, as evidence suggests a dose-response relationship, such that each additional CR session attended reduces morbidity and mortality. Innovative program designs are needed to deliver sustained, equitable CR participation among ACS patients.

The central hypothesis of this research study is that TeleheartCR will show greater program implementation (better adherence [primary], acceptability, and appropriateness) and will be just as effective (non-inferior pre- to post-intervention change in functional capacity [primary], health-related quality of life, and cardiorespiratory fitness) relative to clinic-based CR. The TeleheartCR program includes up to 36 sessions delivered through a combination of clinic-based and home-based sessions and is typically completed over approximately 12 weeks. To allow for scheduling flexibility and clinical considerations, participants may be allowed up to 6 months post-enrollment to complete the program and outcome assessments. To formally test the hypothesis, the investigator will conduct an adequately powered effectiveness-implementation hybrid type I randomized controlled trial (RCT) comparing the TeleheartCR program vs. clinic-based CR among ACS patients.

Specifically, this study will determine the degree to which the TeleheartCR program improves CR adherence, clinical outcomes (e.g., functional capacity), and equitable cost/access (i.e., across SES, racial, and ethnic groups) relative to clinic-based CR among ACS patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center
        • Contact:
        • Principal Investigator:
          • Andrea T Duran, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TeleheartCR
Participants will receive Telehealth-enhanced Hybrid Cardiac Rehabilitation Program
Behavioral: 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.
Active Comparator: Traditional CR
Participants will receive Traditional Clinic-based Cardiac Rehabilitation Program
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of targeted sessions completed (Program Adherence)
Time Frame: During the cardiac rehabilitation program (up to 6 months)
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
Time Frame: Baseline and end of program (up to 6 months)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Acceptability of Intervention Measure Score (Program Acceptability)
Time Frame: End of program (up to 6 months)
Acceptability will be assessed using the Acceptability of Intervention Measure (AIM), a 4-item measure rated on a 1-5 Likert scale. The mean score will be calculated (range: 1-5), with higher scores indicating greater acceptability.
End of program (up to 6 months)
Mean Intervention Appropriateness Measure Score (Program Appropriateness)
Time Frame: End of program (up to 6 months)
Appropriateness will be assessed using the Intervention Appropriateness Measure (IAM), a 4-item measure rated on a 1-5 Likert scale. The mean score will be calculated (range: 1-5), with higher scores indicating greater appropriateness.
End of program (up to 6 months)
Change in Health-Related Quality of Life Score
Time Frame: Baseline and end of program (up to 6 months)
Health-related quality of life will be assessed using the Duke Health Profile (DUKE), a 17-item self-report measure. Scores are used to calculate a general health composite score (range: 0 to 100), with higher scores indicating better health-related quality of life. Change will be calculated as the difference between post-program and baseline scores.
Baseline and end of program (up to 6 months)
Change in METs Achieved During Exercise Testing
Time Frame: Baseline and end of program (up to 6 months)
Cardiorespiratory fitness will be assessed using a symptom-limited graded exercise treadmill test. Metabolic equivalents (METs) achieved during exercise testing will be derived from test performance. Change will be calculated as the difference between post-program and baseline METs.
Baseline and end of program (up to 6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Columbia University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrea T. Duran, PhD, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 19, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AAAV3946
  • 5R01MD019189-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) will be shared, including demographic, clinical, and outcome data underlying the results reported in publications.

IPD Sharing Time Frame

Data will be made available after publication of the primary study results and will remain available for at least 10 years thereafter.

IPD Sharing Access Criteria

De-identified data will be made publicly available via an open-access repository. No personally identifiable information will be shared.

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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