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

Official title

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

Overview

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

• 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
• 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.

Primary outcome measures

• Proportion of targeted sessions completed (Program Adherence) [Time frame: 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)]

Secondary outcome measures (4)

• Mean Acceptability of Intervention Measure Score (Program Acceptability) [Time frame: End of program (up to 6 months)]
• Mean Intervention Appropriateness Measure Score (Program Appropriateness) [Time frame: 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)]
• Change in METs Achieved During Exercise Testing [Time frame: Baseline and end of program (up to 6 months)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Columbia University Irving Medical Center — New York

Identifiers

NCT: NCT07541014 · AAAV3946 · 5R01MD019189-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗