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

Birthe Dinesen, Lars Dittmann, Josefine Dam Gade, Cecilia Klitgaard Jørgensen, Malene Hollingdal, Soeren Leth, Camilla Melholt, Helle Spindler, Jens Refsgaard, Birthe Dinesen, Lars Dittmann, Josefine Dam Gade, Cecilia Klitgaard Jørgensen, Malene Hollingdal, Soeren Leth, Camilla Melholt, Helle Spindler, Jens Refsgaard

Abstract

Background: Cardiovascular 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.

Objective: The 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.

Methods: A 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.

Results: Data 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.

Conclusions: The 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 registration: ClinicalTrials.gov NCT03388918; https://ichgcp.net/clinical-trials-registry/NCT03388918.

International registered report identifier (irrid): DERR1-10.2196/14517.

Keywords: heart failure; patient education; quality of life; research design; telerehabilitation; user-driven innovation.

Conflict of interest statement

Conflicts of Interest: None declared.

©Birthe Irene Dinesen, Lars Dittmann, Josefine Dam Gade, Cecilia Klitgaard Jørgensen, Malene Hollingdal, Soeren Leth, Camilla Melholt, Helle Spindler, Jens Refsgaard. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 19.09.2019.

Figures

https://www.ncbi.nlm.nih.gov/pmc/articles/instance/6754679/bin/resprot_v8i9e14517_fig1.jpg
Telerehabilitation program in three steps.
https://www.ncbi.nlm.nih.gov/pmc/articles/instance/6754679/bin/resprot_v8i9e14517_fig3.jpg
Screen captures from the HeartPortal. (A) Front page for the patients. (B) Measurement from the pedometer. (C) The information platform. (D) An illustration of the patient-reported outcome.
https://www.ncbi.nlm.nih.gov/pmc/articles/instance/6754679/bin/resprot_v8i9e14517_fig2.jpg
The context of the Future Patient study with the HeartPortal at the center.

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