Home-based Cardiac Rehabilitation in Heart Failure (RURAL-HF)

May 29, 2026 updated by: Ambarish Pandey, University of Texas Southwestern Medical Center

Implementing a Home-based Cardiac Rehabilitation Program Among Rural Patients With Heart Failure

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

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.

Study Type

Interventional

Enrollment (Estimated)

332

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75209
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Baylor Scott and White Health System
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Movn cardiac rehabilitation
Cardiac rehabilitation delivered through Movn app through the use of mHealth.
Device: Movn app
Participants will have 12-week home-based exercise program delivered via a commercially available home-based cardiac rehabilitation platform called Movn. The plan includes an accelerometer, blood pressure scale, and mobile application.
Other Names:
  • Cardiac Rehabilitation
Active Comparator: 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.
Device: Accelerometer
Participants will receive a FitBit for monitoring of physical function.
Other Names:
  • FitBit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite Hierarchical Endpoint
Time Frame: 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.
6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Activity Level
Time Frame: Continuously measured over 6 months.
Daily Step Count
Continuously measured over 6 months.
General Health-Related Quality of Life
Time Frame: Baseline, 3 months, and 6 months
Change in general health-related quality of life assessed using the EuroQol 5 Dimension 5 Level (EQ-5D-5L) instrument. The EQ-5D-5L uses a descriptive system to measure health-related quality of life across five key dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on five levels of severity-ranging from no problems (Level 1) to extreme problems or inability to function (Level 5). A respondent's answers generate a five-digit health state profile that reflects their unique combination of responses (e.g., 12345), representing one of 3,125 possible health states. This descriptive system enables consistent and standardized assessment of an individual's health status.
Baseline, 3 months, and 6 months
Implementation Outcomes
Time Frame: Assessed at 3 and 6 months.
Assessment of the implementation of the cardiac rehabilitation program using mixed methods evaluation.
Assessed at 3 and 6 months.
Depressive Symptoms
Time Frame: Baseline, 3 months, and 6 months
Change in mental health parameters assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 ranges from 0 to 27, with higher scores indicating more severe depressive symptoms.
Baseline, 3 months, and 6 months
Anxiety Symptoms
Time Frame: Baseline, 3 months, and 6 months
Change in anxiety symptoms assessed using the Generalized Anxiety Disorder-7 (GAD-7) scale. Total scores range from 0 to 21, with higher scoes indicating more severe anxiety symptoms.
Baseline, 3 months, and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2025

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

March 31, 2024

First Submitted That Met QC Criteria

March 31, 2024

First Posted (Actual)

April 5, 2024

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU-2023-0745

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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