Abstract
BackgroundHeart failure (HF) is a highly prevalent chronic disease, for which there is no cure available. Therefore, improving disease management is crucial, with mobile health (mHealth) being a promising technology. The aim of the HeartMan study is to evaluate the effect of a personal mHealth system on top of standard care on disease management and health-related quality of life (HRQoL) in HF.MethodsHeartMan is a randomized controlled 1:2 (control:intervention) proof-of-concept trial, which will enrol 120 stable ambulatory HF patients with reduced ejection fraction across two European countries. Participants in the intervention group are equipped with a multi-monitoring health platform with the HeartMan wristband sensor as the main component. HeartMan provides guidance through a decision support system on four domains of disease management (exercise, nutrition, medication adherence and mental support), adapted to the patient’s medical and psychological profile. The primary endpoint of the study is improvement in self-care and HRQoL after a six-months intervention. Secondary endpoints are the effects of HeartMan on: behavioural outcomes, illness perception, clinical outcomes and mental state.DiscussionHeartMan is technologically the most innovative HF self-management support system to date. This trial will provide evidence whether modern mHealth technology, when used to its full extent, can improve HRQoL in HF.Trial registrationThis trial has been registered on https://clinicaltrials.gov/ct2/show/NCT03497871, on April 13 2018 with registration number NCT03497871.
Highlights
Heart failure (HF) is a highly prevalent chronic disease, for which there is no cure available
Some studies report that health-related quality of life (HRQoL) and health status may be predictive of clinical events in HF [15, 16], suggesting a relation between both types of outcome. These findings indicate that patients’ perceptions of worsening symptoms might carry vital prognostic information, and should be implemented in trials evaluating disease management
This paper presents the study protocol of HeartMan (Personal Decision Support System For Heart Failure Management) which aims to develop a personal health system to improve disease management and HRQoL in HF
Summary
Heart failure (HF) is a highly prevalent chronic disease, for which there is no cure available. Improving disease management is crucial, with mobile health (mHealth) being a promising technology. The aim of the HeartMan study is to evaluate the effect of a personal mHealth system on top of standard care on disease management and health-related quality of life (HRQoL) in HF. Treatment improvements have decreased the number of hospitalizations and deaths due to HF, the burden remains high with half of the HF patients being expected to die within five years after diagnosis, and HF being the most frequent cause of hospitalization in people aged over 65 [2]. Proper disease management may relieve symptoms, prevent hospitalization or improve survival, but may affect the patient’s health-related quality of life (HRQoL). Of particular concern is the poor implementation of exercise guidelines [5]: participation rates of HF patients in cardiac rehabilitation are generally below
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