Columbia University Irving Medical Center
New York, 10032, United States
Location status: Recruiting
Location contact
Andrea T Duran, PhD
CONTACT
Andrea T Duran, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07541014
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
New York, 10032, United States
Location status: Recruiting
Andrea T Duran, PhD
CONTACT
Andrea T Duran, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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).
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Columbia University
Other
Comparing a Novel Telehealth-enabled Hybrid Cardiac Rehabilitation Program to Clinic-based Cardiac Rehabilitation for Improving Patient Engagement and Functional Outcomes After ACS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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