Heart Failure Clinical Trial
— RURAL-HFOfficial title:
Leveraging Telemedicine to Assess Care Quality and Improve Care Utilization Among Rural Patients With Heart Failure: The RURAL-HF Pilot Project
Verified date | March 2024 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
We propose a pilot trial examining the effectiveness of a mHealth-based home cardiac rehabilitation program using a telemedicine platform for the identification, recruitment, and retention of an underserved rural population with heart failure with reduced ejection fraction.(HFrEF). The goal of the pilot trial will be to demonstrate the feasibility of a telemedicine platform for the recruitment and retention of underserved rural patients in clinical trials. Participants will participate in a cardiac rehabilitation program delivered through a smartphone application called Movn. They will be monitored for 14 weeks.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | December 1, 2024 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age more than 18 years - NYHA class II, III symptoms Exclusion Criteria: - Need for inotropes or cardiac index < 2.2 L/min/m2 - planned revascularization within 3o days - planned cardiac transplantation or LVAD implantation - inability to walk or otherwise participate in exercise based cardiac rehabilitation - comorbidities that may be expected to limit lifespan during follow-up period - active cancer diagnosis - inability to provide written consent |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Physical activity levels | Fitbit recorded steps walked | Over 14 weeks | |
Primary | Quality of life using KCCQ score | Reported using the well-established, previously validated Kansas City Cardiomyopathy Questionnaire (KCCQ). | Baseline, 1 month after run-in period and 3 months after 2-weeks run-in | |
Secondary | Enrollment rate | Ratio of enrolled to contacted patients. | At the beginning of study | |
Secondary | Loss to follow up | Proportion of participants adhering to the study protocol and completing the study | Over 14 weeks |
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