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A Personal Decision Support System for Heart Failure Management (HeartMan): study protocol of the HeartMan randomized
Anneleen Baert1, Els Clays1, Larissa Bolliger1
1Department of Public Health, Ghent University, University Hospital Ghent, entrance 42 (4K3) Corneel Heymanslaan 10, 9000, Ghent, Belgium.
This study investigated the HeartMan mobile health system for heart failure (HF) patients. The system aims to improve self-care and quality of life through personalized guidance on exercise, nutrition, medication, and mental support.
Area of Science:
- Cardiology
- Digital Health
- Health Services Research
Background:
- Heart failure (HF) is a widespread chronic condition lacking a cure, necessitating improved disease management strategies.
- Mobile health (mHealth) presents a promising technological avenue for enhancing HF patient care.
- The HeartMan study focuses on leveraging mHealth for better self-management in heart failure patients.
Purpose of the Study:
- To assess the impact of a personalized mHealth system, HeartMan, on disease management and health-related quality of life (HRQoL) in heart failure patients.
- To evaluate the efficacy of the HeartMan system as an adjunct to standard care for stable ambulatory HF patients.
Main Methods:
- A randomized controlled trial (1:2 ratio) involving 120 stable ambulatory HF patients with reduced ejection fraction across two European countries.
- The intervention group utilized the HeartMan platform, featuring a wristband sensor and decision support system for exercise, nutrition, medication adherence, and mental support.
- Primary endpoint: improvement in self-care and HRQoL after a six-month intervention. Secondary endpoints included behavioral, illness perception, clinical, and mental state outcomes.
Main Results:
- The study is designed to provide evidence on the effectiveness of the HeartMan system.
- Results will indicate whether advanced mHealth technology can enhance HRQoL in HF patients.
Conclusions:
- The HeartMan system represents a cutting-edge approach to HF self-management support.
- This trial will determine the potential of comprehensive mHealth solutions to improve the quality of life for individuals with heart failure.
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