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A personal decision support system for heart failure management (HeartMan) : study protocol of the HeartMan randomized controlled trial

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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.
Keywords
mHealth, Disease management, Heart failure, Health-related quality of life, Decision support system, EUROPEAN-SOCIETY, CONSENSUS DOCUMENT, ASSOCIATION, REHABILITATION, EPIDEMIOLOGY, INFORMATION, PREVENTION, MORTALITY, CARE

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MLA
Baert, Anneleen, Els Clays, Larissa Bolliger, et al. “A Personal Decision Support System for Heart Failure Management (HeartMan) : Study Protocol of the HeartMan Randomized Controlled Trial.” BMC CARDIOVASCULAR DISORDERS 18 (2018): n. pag. Print.
APA
Baert, Anneleen, Clays, E., Bolliger, L., De Smedt, D., Lustrek, M., Vodopija, A., Bohanec, M., et al. (2018). A personal decision support system for heart failure management (HeartMan) : study protocol of the HeartMan randomized controlled trial. BMC CARDIOVASCULAR DISORDERS, 18.
Chicago author-date
Baert, Anneleen, Els Clays, Larissa Bolliger, Delphine De Smedt, Mitja Lustrek, Aljoša Vodopija, Marko Bohanec, et al. 2018. “A Personal Decision Support System for Heart Failure Management (HeartMan) : Study Protocol of the HeartMan Randomized Controlled Trial.” Bmc Cardiovascular Disorders 18.
Chicago author-date (all authors)
Baert, Anneleen, Els Clays, Larissa Bolliger, Delphine De Smedt, Mitja Lustrek, Aljoša Vodopija, Marko Bohanec, Paolo Emilio Puddu, Maria Costanza Ciancarelli, Michele Schiariti, Jan Derboven, Gennaro Tartarisco, and Sofie Pardaens. 2018. “A Personal Decision Support System for Heart Failure Management (HeartMan) : Study Protocol of the HeartMan Randomized Controlled Trial.” Bmc Cardiovascular Disorders 18.
Vancouver
1.
Baert A, Clays E, Bolliger L, De Smedt D, Lustrek M, Vodopija A, et al. A personal decision support system for heart failure management (HeartMan) : study protocol of the HeartMan randomized controlled trial. BMC CARDIOVASCULAR DISORDERS. 2018;18.
IEEE
[1]
A. Baert et al., “A personal decision support system for heart failure management (HeartMan) : study protocol of the HeartMan randomized controlled trial,” BMC CARDIOVASCULAR DISORDERS, vol. 18, 2018.
@article{8586509,
  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.},
  articleno    = {186},
  author       = {Baert, Anneleen and Clays, Els and Bolliger, Larissa and De Smedt, Delphine and Lustrek, Mitja and Vodopija, Aljoša and Bohanec, Marko and Puddu, Paolo Emilio and Ciancarelli, Maria Costanza and Schiariti, Michele and Derboven, Jan and Tartarisco, Gennaro and Pardaens, Sofie},
  issn         = {1471-2261},
  journal      = {BMC CARDIOVASCULAR DISORDERS},
  keywords     = {mHealth,Disease management,Heart failure,Health-related quality of life,Decision support system,EUROPEAN-SOCIETY,CONSENSUS DOCUMENT,ASSOCIATION,REHABILITATION,EPIDEMIOLOGY,INFORMATION,PREVENTION,MORTALITY,CARE},
  language     = {eng},
  pages        = {9},
  title        = {A personal decision support system for heart failure management (HeartMan) : study protocol of the HeartMan randomized controlled trial},
  url          = {http://dx.doi.org/10.1186/s12872-018-0921-2},
  volume       = {18},
  year         = {2018},
}

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