Implementing a Home-based Cardiac Rehabilitation Program Among Rural Patients With Heart Failure
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 332
- 试验地点
- 4
- 主要终点
- Composite Hierarchical Endpoint
研究概览
简要总结
This study evaluates a mobile health (mHealth) home-based cardiac rehabilitation program for patients with heart failure. We will stratify randomization between rural and urban populations, with the goal to assess implementation of cardiac rehabilitation across these two geographic areas. . The study will randomize 332 patients with heart failure (ejection fraction ≥35%) who are not eligible for center-based rehabilitation to either a 12-week mHealth cardiac rehabilitation program or an attention control group, with outcomes measured over 6 months using a composite endpoint of mortality, hospitalizations, and quality of life. We will then assess the implementation of the intervention.
详细描述
Background and Significance:
Rural communities in the United States experience a disproportionate burden of cardiovascular disease and associated adverse outcomes, with recent epidemiological data demonstrating a widening mortality gap compared to urban populations. These disparities are particularly pronounced in cardiovascular care delivery, where rural-residing adults demonstrate significantly lower rates of guideline-directed therapies for coronary heart disease, heart failure, and stroke. Among the most substantial gaps identified is the utilization of cardiac rehabilitation services, with total participation among Medicare beneficiaries reaching only 5% in rural areas. This disparity is compounded by the intersection of multiple risk factors including reduced access to healthcare services, lower socioeconomic status, and geographic barriers to specialized care.
The emergence of telemedicine platforms presents a novel opportunity to address these healthcare access disparities through innovative service delivery models. The COVID-19 pandemic has catalyzed the adoption of digital health technologies, with telemedicine visits among rural Medicare beneficiaries increasing nearly 100-fold between 2019 and 2020. Concurrent improvements in rural broadband access, with over 70% of rural adults reporting home broadband availability in 2021, have created an infrastructure foundation supporting telehealth interventions. Mobile health (mHealth) interventions have demonstrated efficacy in cardiovascular care through patient monitoring, medication adherence support, and risk factor management, with preliminary evidence suggesting effectiveness in reducing rehospitalizations and increasing patient participation in cardiac rehabilitation programs.
Study Design and Methodology:
This investigation employs a randomized, open-label, Type 1 hybrid effectiveness-implementation trial design to evaluate the efficacy and implementation characteristics of an mHealth-enabled home-based cardiac rehabilitation program. The study will enroll 332 adult participants with recent hospitalization for heart failure with ejection fraction ≥35%, stratified with 70% recruitment from rural hospitals and 30% from urban centers to enable comparative analysis of implementation challenges across geographic settings. Participants will be randomized in a 1:1 ratio to receive either the mHealth cardiac rehabilitation intervention or attention control, with outcomes assessed over a 6-month follow-up period.
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
- None
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
- •Adults aged 18 years or older
- •History of hospitalization for acute heart failure within the last 12 months
- •Ability to participate in telemedicine visits
- •Access to smartphone or device capable of running the mHealth application
- •Willingness to participate in home-based cardiac rehabilitation program
排除标准
- •Inability to participate in physical exercise or cardiac rehabilitation due to medical contraindications
- •Inability to provide informed consent
- •Lack of access to required technology (smartphone, internet connectivity)
- •Life expectancy less than 6 months
- •Inability to participate in telemedicine visits or remote monitoring
- •Current participation in another cardiac rehabilitation program
研究组 & 干预措施
Movn cardiac rehabilitation
Cardiac rehabilitation delivered through Movn app through the use of mHealth.
干预措施: Movn app (Device)
Attention Control
This group will receive a wearable device for step count tracking and will get periodic check ins to minimize differential attention between groups. They will not receive an exercise plan.
干预措施: Accelerometer (Device)
结局指标
主要结局
Composite Hierarchical Endpoint
时间窗: 6 months.
A composite outcome incorporating all-cause mortality, time to first heart failure hospitalization, total heart failure hospitalizations, and a 5-point difference in disease-specific quality of life score as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ ranges from 0-100, where 0 indicates worst quality of life and 100 indicates best quality of life.
次要结局
- Physical Activity Level(Continuously measured over 6 months.)
- General Health-Related Quality of Life(Baseline, 3 months, and 6 months)
- Implementation Outcomes(Assessed at 3 and 6 months.)
- Depressive Symptoms(Baseline, 3 months, and 6 months)
- Anxiety Symptoms(Baseline, 3 months, and 6 months)
研究者
Ambarish Pandey
Associate Professor
University of Texas Southwestern Medical Center
