Clinical trial NCT06349941: Telemedicine in Rural Patients With Heart Failure
Official title: Leveraging Telemedicine to Assess Care Quality and Improve Care Utilization Among Rural Patients With Heart Failure: The RURAL-HF Pilot Project
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: telehealth
heart failure
rural
cardiac rehabilitaion
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot trial
Primary purpose: OTHER

Brief summary: 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.

Detailed description: We propose a pilot trial examining the effectiveness of a mHealth-based home CR program using a telemedicine platform for the identification, recruitment, and retention of an underserved rural population with HFrEF. This will be a non-randomized pre-post design comparing a mHealth home CR program to usual care in adults with HFrEF (less than 40%). The targeted enrollment is 50 adults hospitalized with HFrEF and receiving care in rural hospitals, with 20 patients enrolled in year 1 and 30 patients enrolled in year 2. The follow-up duration will be 14 weeks. 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.

Study site and participants: We will enroll patients hospitalized in rural hospitals with decompensated HFrEF who receive cardiovascular telemedicine care through the SOC Telemedicine. Outpatient study follow-up will be performed virtually using the telemedicine platform.

The trial aims to enroll adults age ≥18 years with HFrEF (LVEF less than 40%) following the index HF hospitalization. All patients hospitalized with HFrEF, including those with New York Heart Association class II, III, or IV symptoms, will be invited to participate.

Recruitment - Patients deemed eligible for participation will be contacted prior to discharge for their HF hospitalization from participating Access Telecare sites. Patients will be informed about the study, its goals, and the risks and benefits of participating. Patients will be scheduled with an at-home virtual baseline/screening visit post-discharge. Participants will be nonrandomly assigned to the intervention in a pre-post design. Participants will have a 2-week run-in period followed by 12-weeks of cardiac rehabilitation. We conservatively estimate that we will need to contact 100 patients over the 2-year enrollment period to enroll 50 patients in the study. We will record all contact attempts and responses to determine recruitment rates and reasons for opting out of the trial.

Study intervention - mHealth based cardiac rehabilitation and mobile physical activity monitoring. Participants will receive a FitBit accelerometer to monitor physical activity. Participants will have a 2-week run-in period where physical activity levels will be monitored followed by a 12-week home-based exercise program delivered via a previously validated, commercially available smartphone platform called Movn (Moving Analytics, California). The study investigators will not share any research data with Movn. Movn will communicate with the patient to conduct cardiac rehabilitation as per their program. This app includes a patient-facing iOS and Android compatible smartphone app and an integrated hospital-facing online dashboard for remote monitoring and care coordination by a trained coach.

Study endpoints: The primary endpoints of interest will be physical activity levels and quality of life at study end. Physical activity levels will be monitored by Fitbit recorded steps walked. Patient-reported quality of life will be reported using the well-established, previously validated Kansas City Cardiomyopathy Questionnaire (KCCQ). Study-level endpoints to evaluate the feasibility of the telemedicine-based recruitment strategy will include measurement of enrollment rates (ratio of enrolled to contacted patients), loss to follow-up over the 14-week study period, and surveyed responses exploring reasons and barriers for participation or non-participation.

Eligibility criteria: 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

Primary outcomes:
measure: Physical activity levels
timeFrame: Over 14 weeks
measure: Quality of life using KCCQ score
timeFrame: Baseline, 1 month after run-in period and 3 months after 2-weeks run-in
Secondary outcomes:
measure: Enrollment rate
timeFrame: At the beginning of study
measure: Loss to follow up
timeFrame: Over 14 weeks
Other outcomes:
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