Acute Coronary Syndrome (ACS), Myocardial Infarction
Conditions
Keywords
Cardiac Rehabilitation, Hybrid Cardiac Rehabilitation, Virtual Cardiac Rehabilitation, Implementation Science, Adherence, Functional Capacity, Telehealth
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.
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.
Interventions
BEHAVIORALTelehealth-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.
BEHAVIORALTraditional 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.
Sponsors
Columbia University
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of targeted sessions completed (Program Adherence) | 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). |
| Change in 6-Minute Walk Test Distance | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Acceptability of Intervention Measure Score (Program Acceptability) | 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. |
| Mean Intervention Appropriateness Measure Score (Program Appropriateness) | 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. |
| Change in Health-Related Quality of Life Score | 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. |
| Change in METs Achieved During Exercise Testing | 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. |
Countries
United States
Contacts
CONTACTAndrea T Duran, PhD
PRINCIPAL_INVESTIGATORAndrea T. Duran, PhD
Columbia University
Outcome results
None listed