Comparing a Novel Telehealth-enabled Hybrid Cardiac Rehabilitation Program to Clinic-based Cardiac Rehabilitation for Improving Patient Engagement and Functional Outcomes After ACS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Proportion of targeted sessions completed (Program Adherence)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
TeleheartCR
Participants will receive Telehealth-enhanced Hybrid Cardiac Rehabilitation Program
干预措施: Telehealth-enhanced Hybrid CR (Behavioral)
Traditional CR
Participants will receive Traditional Clinic-based Cardiac Rehabilitation Program
干预措施: Traditional Cardiac Rehabilitation (Behavioral)
结局指标
主要结局
Proportion of targeted sessions completed (Program Adherence)
时间窗: 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
时间窗: 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.
次要结局
- Mean Acceptability of Intervention Measure Score (Program Acceptability)(End of program (up to 6 months))
- Mean Intervention Appropriateness Measure Score (Program Appropriateness)(End of program (up to 6 months))
- Change in Health-Related Quality of Life Score(Baseline and end of program (up to 6 months))
- Change in METs Achieved During Exercise Testing(Baseline and end of program (up to 6 months))
研究者
Andrea Duran
Assistant Professor of Medical Sciences
Columbia University