RightFit
RecruitingPhase 3

Home-based Cardiac Rehabilitation in Heart Failure

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Wearing a device, Questionnaires, Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

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 sites (2)

TX