TeleheartCR vs. Clinic-Based Cardiac Rehabilitation After Acute Coronary Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorColumbia University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Telehealth-enhanced Hybrid CR
BehavioralThe 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
BehavioralThe 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.
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: TeleheartCRExperimental treatment 1 intervention
Group B: Traditional CRActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
During the cardiac rehabilitation program (up to 6 months)2
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.
Time frame
Baseline and end of program (up to 6 months)Secondary outcomes
1
Mean Acceptability of Intervention Measure Score (Program Acceptability)
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.
Time frame
End of program (up to 6 months)2
Mean Intervention Appropriateness Measure Score (Program Appropriateness)
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.
Time frame
End of program (up to 6 months)3
Change in Health-Related Quality of Life Score
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.
Time frame
Baseline and end of program (up to 6 months)4
Change in METs Achieved During Exercise Testing
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.
Time frame
Baseline and end of program (up to 6 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Columbia University
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Source ClinicalTrials.gov