临床试验雷达

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.

Intervention Components:

Participants randomized to the mHealth cardiac rehabilitation group receive a comprehensive remote monitoring kit delivered via overnight shipping, containing a wireless blood pressure monitor, resistance bands, and a wearable monitor. These hardware components integrate with the Movn Health platform, which participants access through a smartphone application offering both synchronous and asynchronous features including real-time video consultations with exercise coaches, exercise videos for self-directed sessions, one-to-one messaging capabilities, and automatic data synchronization from all monitoring devices.

The 12-week cardiac rehabilitation program implements a multi-domain physical rehabilitation approach. The intervention begins with a comprehensive assessment evaluating exercise capacity and safety requirements. Each participant follows a personalized exercise regimen.

Participants in the attention control group receive a FitBit device for activity monitoring and step count tracking, along with bi-weekly telephone calls throughout the 12-week intervention period to minimize contact differential between study arms. These telephone interactions focus on general health discussions without providing specific exercise counseling or rehabilitation guidance.

Outcome Measures and Assessment:

The primary endpoint employs a composite hierarchical outcome structure analyzed using a win-ratio methodology, incorporating all-cause mortality, time to first heart failure hospitalization, total heart failure hospitalizations, and a 5-point difference in quality of life assessed by the Kansas City Cardiomyopathy Questionnaire. This analytical approach provides a comprehensive evaluation of intervention effectiveness across multiple clinically relevant domains while accounting for the relative importance of mortality and morbidity outcomes.

Secondary endpoints include individual components of the primary composite outcome, physical activity levels measured through FitBit-recorded daily step counts, and general health-related quality of life assessed using the EuroQol 5 Dimension 5 Level instrument. Additional secondary measures encompass mental health parameters evaluated through the Patient Health Questionnaire-9, Generalized Anxiety Disorder-7 scale, and the Physical Activity Scale for the Elderly.

The study incorporates comprehensive implementation outcome assessment using the RE-AIM framework, evaluating Reach through the number of eligible participants receiving the intervention, Effectiveness through perceived relative advantage and observed outcomes, Adoption through adherence rates and contextual factors, Implementation through fidelity measures and cost analysis, and Maintenance through persistence and discontinuation rates. A sequential mixed-methods approach will conduct semi-structured interviews with 12 clinicians across all sites and 36 patients across study arms to evaluate acceptability, preferences, and contextual factors influencing implementation effectiveness.