“Future Patient” Telerehabilitation for Patients With Heart Failure: Protocol for a Randomized Controlled Trial

Abstract

BackgroundCardiovascular disease is the leading cause of mortality worldwide, accounting for 13%-15% of all deaths. Cardiac rehabilitation has poor compliance and adherence. Telerehabilitation has been introduced to increase patients’ participation, access, and adherence with the help of digital technologies. The target group is patients with heart failure. A telerehabilitation program called “Future Patient” has been developed and consists of three phases: (1) titration of medicine (0-3 months), (2) implementation of the telerehabilitation protocols (3 months), and (3) follow-up with rehabilitation in everyday life (6 months). Patients in the Future Patient program measure their blood pressure, pulse, weight, number of steps taken, sleep, and respiration and answer questions online regarding their well-being. All data are transmitted and accessed in the HeartPortal by patients and health care professionals.ObjectiveThe aim of this paper is to describe the research design, outcome measures, and data collection techniques in the clinical test of the Future Patient Telerehabilitation Program for patients with heart failure.MethodsA randomized controlled study will be performed. The intervention group will follow the Future Patient Telerehabilitation program, and the control group will follow the traditional cardiac rehabilitation program. The primary outcome is quality of life measured by the Kansas City Cardiomyopathy Questionnaire. Secondary outcomes are development of clinical data; illness perception; motivation; anxiety and depression; health and electronic health literacy; qualitative exploration of patients’, spouses’, and health care professionals’ experiences of participating in the telerehabilitation program; and a health economy evaluation of the program. Outcomes were assessed using questionnaires and through the data generated by digital technologies.ResultsData collection began in December 2016 and will be completed in October 2019. The study results will be published in peer-reviewed journals and presented at international conferences. Results from the Future Patient Telerehabilitation program are expected to be published by the spring of 2020.ConclusionsThe expected outcomes are increased quality of life, increased motivation and illness perception, reduced anxiety and depressions, improved electronic health literacy, and health economics benefits. We expect the study to have a clinical impact for future telerehabilitation of patients with heart failure.Trial RegistrationClinicalTrials.gov NCT03388918; https://clinicaltrials.gov/ct2/show/NCT03388918International Registered Report Identifier (IRRID)DERR1-10.2196/14517

The Danish Future Patient Telerehabilitation Program for Patients With Atrial Fibrillation: Design and Pilot Study in Collaboration With Patients and Their Spouses

“…Through interviews, patients articulated the following themes (Textbox 2) about their participation in a TR program: the HeartPortal is a useful tool, increased feeling of security while living with AF, being part of a community of practice living with AF, and measuring one's heart rhythm makes good sense in AF disease management. The findings from the FP-AF study are in line with the findings from a qualitative study by Dinesen et al [22] on TR in patients with HF. These patients stated that TR technologies and access to their own data provided a relevant overview for the patients in relation to their rehabilitation…”

“…The module consists of an interactive information site for patient education, a communication platform enabling patients to communicate directly with health care professionals through chat or video consultations with health care professionals, a self-tracking module with visualization of measured data, and questionnaires. These devices were chosen based on the FP-TR program for patients with HF [22]. • At enrollment, the project nurse orients the patients and spouses briefly on the following topics knowledge of atrial fibrillation (AF), AF medication, AF attacks, mental health, lifestyle changes, and body awareness.…”

“…The spouses (Textbox 2) also expressed that they felt more like part of a community of practice with the other spouses participating in education at the health care center. The qualitative study by Dinesen et al [22] on TR in patients with HF also explored how their spouses participated in a TR program. They found that the spouses had an increased sense of security, they took too much responsibility on behalf of their partner, and that they tended to push their partner too hard at times.…”

Motivating Patients in Cardiac Rehabilitation Programs: A Multicenter Randomized Controlled Trial

“…As such, our non-significant results are therefore not negative per se, but they cannot readily be assumed to infer non-inferiority, as our study was not powered sufficiently to support such an analysis (Schumi & Witter, 2011). Although a power analysis had been carried out for the main study, this was aimed at identifying significant changes on the KCCQ aiming for superiority testing (see Dinesen et al, 2019), rather than non-inferiority testing. In sum, future studies are needed to address the issue of non-inferiority between telerehabilitation and conventional rehabilitation.…”

Application of the eHealth Literacy Model in Digital Health Interventions: Scoping Review

“…Mobile-based interventions included health apps [55][56][57], SMS text messaging or WhatsApp [58], games [59,60], and interactive voice response [61,62]. Telehealth interventions included rehabilitation programs [63,64] or remote counseling [65]. Hybrid interventions included combinations of mobile apps and EHRs [55][56][57], SMS text messaging and EHRs [66], or a mix of web-and mobile-based technologies [67].…”