Future Patient – Telerehabilitation of Patients with Atrial Fibrillation: Protocol for a Multicenter, Mixed methods, and Randomized Controlled Trial (Preprint)

BACKGROUND Atrial Fibrillation (AF) is a chronic cardiovascular condition with a lifetime risk of one in three, and a prevalence of 3% among adults. The prevalence of AF is predicted to more than double in the next 20 years due to better detection, increasing comorbidities, and an ageing population. Telerehabilitation has been developed to enhance patient’s engagement, healthcare accessibility, and compliance through digital technologies. A telerehabilitation program called ‘Future Patient’ has been developed for rehabilitation of AF patients. Future Patient consists of 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, the HeartPortal, on their digital devices. Patients in the Future Patient Atrial Fibrillation (FP-AF) program measures their heart rhythm, pulse, blood pressure, weight, steps and sleep. They also complete online questionnaires regarding their well-being and coping with AF. All recorded data is transmitted to the HeartPortal, accessible to patients, relatives, and healthcare professionals. OBJECTIVE This paper aims to describe the research design, outcome measures, and data collection techniques in the clinical trial of the FP-AF Program for patients with AF. METHODS This is a multicenter, mixed methods, randomized controlled study. Patients are recruited from AF clinics. 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; anxiety and depression; motivation; burden of AF; use of 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. The outcomes are assessed through data from digital technologies and collected from interviews and questionnaires. RESULTS Enrollment of patients started in January 2023 and will be completed by December 2024, with a total of 208 patients enrolled. Qualitative interviews conducted in the spring of 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 explore whether the FP-AF program can increase quality of life for AF patients and increase their knowledge of symptoms and living with AF in everyday life. The cost-effectiveness evaluation will evaluate whether telerehabilitation can be a viable alternative for rehabilitation of AF patients. CLINICALTRIAL Clinicaltrials.gov NCT06101485, registered on June 26th, 2023. Approved by The North Denmark Region Committee on Health Research Ethics N-20220056.