Future Patient-Telerehabilitation of Patients With Atrial Fibrillation: Protocol for a Multicenter, Mixed Methods, Randomized Controlled Trial.

Abstract

Background: Atrial fibrillation (AF) is a chronic cardiovascular condition with a lifetime risk of 1 in 3 and a prevalence of 3% among adults. AF's prevalence is predicted to more than double during the next 20 years due to better detection, increasing comorbidities, and an aging population. Due to increased AF prevalence, telerehabilitation has been developed to enhance patient engagement, health care accessibility, and compliance through digital technologies. A telerehabilitation program called "Future Patient-telerehabilitation of patients with AF (FP-AF)" has been developed to enhance rehabilitation for AF. The FP-AF program comprises two modules: (1) an education and monitoring module using telerehabilitation technologies (4 months) and (2) a follow-up module, where patients can measure steps and access a data and knowledge-sharing portal, HeartPortal, using their digital devices. Those patients in the FP-AF program measure their heart rhythm, pulse, blood pressure, weight, steps, and sleep. Patients also complete web-based questionnaires regarding their well-being and coping with AF. All recorded data are transmitted to the HeartPortal, accessible to patients, relatives, and health care professionals.

Objective: This paper aims to describe the research design, outcome measures, and data collection techniques in a clinical trial of the FP-AF program for patients with AF.

Methods: This is a multicenter, mixed methods, randomized controlled trial. Patients are recruited from AF clinics serving the North Jutland region of Denmark. The telerehabilitation group will participate in the FP-AF program, while the control group will follow the conventional care regime based on physical visits to the AF clinic. The primary outcome measure is AF-specific health-related quality of life, to be assessed using the Atrial Fibrillation Effect on Quality-of-Life Questionnaire. Secondary outcomes are knowledge of AF; measurement of vital parameters; level of anxiety and depression; degree of motivation; burden of AF; use of the HeartPortal; qualitative exploration of patients', relatives', and health care professionals' experiences of participating in the FP-AF program; cost-effectiveness evaluation of the program; and analysis of multiparametric monitoring data. Outcomes are assessed through data from digital technologies, interviews, and questionnaires.

Results: Patient enrollment began in January 2023 and will be completed by December 2024, with a total of 208 patients enrolled. Qualitative interviews conducted in spring 2024 will be analyzed and published in peer-reviewed journals in 2025. Data from questionnaires and digital technologies will be analyzed upon study completion and presented at international conferences and published in peer-reviewed journals by the fall of 2025.

Conclusions: Results from the FP-AF study will determine whether the FP-AF program can increase quality of life for patients with AF and increase their knowledge of symptoms and living with AF in everyday life compared to conventional AF care. The cost-effectiveness evaluation will determine whether telerehabilitation can be a viable alternative for rehabilitation of patients with AF.

Trial registration: ClinicalTrials.gov NCT06101485; https://clinicaltrials.gov/study/NCT06101485.

International registered report identifier (irrid): DERR1-10.2196/64259.