A Personal Decision Support System for Heart Failure Management (HeartMan): study protocol of the HeartMan randomized controlled trial

BMC Cardiovascular Disorders

on behalf of the HeartMan consortium¹  Paolo Emilio Puddu²  Michele Schiariti²  Maria Costanza Ciancarelli²  Mitja Lustrek³  Aljoša Vodopija³  Marko Bohanec⁴  Sofie Pardaens⁵  Els Clays⁵  Larissa Bolliger⁵  Delphine De Smedt⁵  Anneleen Baert⁵  Gennaro Tartarisco⁶  Jan Derboven⁷ 

[1] ;Department of Cardiovascular Sciences, Sapienza University of Rome;Department of Intelligent Systems, Jožef Stefan Institute;Department of Knowledge Technologies, Jožef Stefan Institute;Department of Public Health, Ghent University, University Hospital Ghent;Italian National Research Council (CNR) – Institute of Applied Science and Intelligent System (IASI), Messina Unit;Mintlab, KU Leuven;

关键词: mHealth;    Disease management;    Heart failure;    Health-related quality of life;    Decision support system;   

DOI  :  10.1186/s12872-018-0921-2

来源: DOAJ

【 摘 要 】

Abstract Background Heart 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. Methods HeartMan 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. Discussion HeartMan 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 registration This trial has been registered on https://clinicaltrials.gov/ct2/show/NCT03497871, on April 13 2018 with registration number NCT03497871.

【 授权许可】

Unknown