Elisabet Dortea Ragnvaldsdóttir Joensen

Background: Atrial fibrillation (AF) is a prevalent chronic condition with increasing incidence worldwide. AF increases the risks of stroke, heart failure, and myocardial infarction and imposes a substantial burden on the health care system. Cardiac rehabilitation programs, while effective, often have low patient adherence. Recent evidence suggests that cardiac telerehabilitation, where patients are given home monitoring devices, could enhance adherence and outcomes. The program “Future Patient—Telerehabilitation of Patients with AF” (FP-AF) was created to assess the effects and potential benefits of cardiac telerehabilitation on patients with AF. Objective: The objective of this study is to explore the experiences of patients participating in the FP-AF program. Methods: This qualitative sub-study is part of the multicenter, randomized controlled FP-AF trial, which included 208 patients. Semi-structured interviews were conducted on 14 patients, randomly selected from participants in the intervention arm of the FP-AF program. The patient interviews, guided by self-determination theory, focused on patients’ experiences with the FP-AF program, including the use of telerehabilitation technologies and a web-based portal called the “HeartPortal.” Interview responses were analyzed using NVivo software (version 14.0; QSR International), with thematic coding based on interview guides and methodological guidance elaborated by Brinkmann & Kvale. The study adhered to ethical guidelines, with informed consent obtained from all participants. Results: Based on the interviews, the following themes were identified: the home monitoring devices are viewed positively by the patients; the HeartPortal is a useful digital toolbox; patients develop new coping strategies for living with AF; the measured values are useful for the patients; the community of practice is beneficial; and the FP-AF program creates a sense of security. Conclusions: Participation in the FP-AF program enhanced patients’ sense of security, empowerment, and knowledge about AF. This improvement was due largely to a combination of patients’ use of the HeartPortal and the educational sessions at health care centers. Telerehabilitation for patients with AF may be a useful way of researching this group of patients with a focus on rehabilitation and may be an effective means of offering rehabilitation to this group in the future.

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

BACKGROUND Atrial fibrillation (AF) is a prevalent chronic condition with increasing incidence worldwide. AF increases the risks of stroke, heart failure, and myocardial infarction and imposes a substantial burden on the healthcare system. Cardiac rehabilitation programs, while effective, often suffer from low patient adherence. Recent evidence suggests that cardiac telerehabilitation, where patients are given home monitoring devices, could enhance adherence and outcomes. The program ‘Future Patient – Telerehabilitation of patients with AF’ (FP-AF) was created to assess the effects and potential benefits of cardiac telerehabilitation on AF patients. This study explores patient experiences with the FP-AF program. OBJECTIVE To explore the experiences of patients participating in the FP-AF program. METHODS This qualitative sub-study is part of the multicenter, randomized controlled FP-AF trial, which included 208 patients. Semi-structured interviews were conducted on 14 patients, randomly selected from participants in the intervention arm of the FP-AF program. The patient interviews, guided by self-determination theory, focused on patients' experiences with the FP-AF program, including the use of telerehabilitation technologies and an interactive web portal called the ‘HeartPortal’. Interview responses were analyzed using NVivo software, with thematic coding based on interview guides and methodological guidance elaborated by Brinkmann & Kvale. The study adhered to ethical guidelines, with informed consent obtained from all participants. RESULTS Based on the interviews, the following themes were identified: The home monitoring devices are viewed positively by the patients, the HeartPortal is a useful digital toolbox, patients develop new coping strategies for living with AF, the measured values are useful for the patients, the community of practice is beneficial, the FP-AF program creates a sense of security. CONCLUSIONS Patients’ participation in the FP-AF program enhanced their sense of security, empowerment, and knowledge about AF. This improvement was largely due to a combination of patients’ use of the HeartPortal and the educational sessions held at the healthcare centers. Telerehabilitation for patients with AF has the potential to be an effective means of offering rehabilitation to this group in the future. CLINICALTRIAL The FP-AF study is listed in ClinicalTrials.gov (NCT06101485) INTERNATIONAL REGISTERED REPORT RR2-10.2196/64259

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. CLINICALTRIAL ClinicalTrials.gov NCT06101485; https://clinicaltrials.gov/study/NCT06101485 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/64259