A Personal Health System for Self-Management of Congestive Heart Failure (HeartMan): Development, Technical Evaluation, and Proof-of-Concept Randomized Controlled Trial.

BACKGROUND: Congestive heart failure (CHF) is a disease that requires complex management involving multiple medications, exercise, and lifestyle changes. It mainly affects older patients with depression and anxiety, who commonly find management difficult. Existing mobile apps supporting the self-management of CHF have limited features and are inadequately validated. OBJECTIVE: The HeartMan project aims to develop a personal health system that would comprehensively address CHF self-management by using sensing devices and artificial intelligence methods. This paper presents the design of the system and reports on the accuracy of its patient-monitoring methods, overall effectiveness, and patient perceptions. METHODS: A mobile app was developed as the core of the HeartMan system, and the app was connected to a custom wristband and cloud services. The system features machine learning methods for patient monitoring: continuous blood pressure (BP) estimation, physical activity monitoring, and psychological profile recognition. These methods feed a decision support system that provides recommendations on physical health and psychological support. The system was designed using a human-centered methodology involving the patients throughout development. It was evaluated in a proof-of-concept trial with 56 patients. RESULTS: Fairly high accuracy of the patient-monitoring methods was observed. The mean absolute error of BP estimation was 9.0 mm Hg for systolic BP and 7.0 mm Hg for diastolic BP. The accuracy of psychological profile detection was 88.6%. The F-measure for physical activity recognition was 71%. The proof-of-concept clinical trial in 56 patients showed that the HeartMan system significantly improved self-care behavior (P=.02), whereas depression and anxiety rates were significantly reduced (P<.001), as were perceived sexual problems (P=.01). According to the Unified Theory of Acceptance and Use of Technology questionnaire, a positive attitude toward HeartMan was seen among end users, resulting in increased awareness, self-monitoring, and empowerment. CONCLUSIONS: The HeartMan project combined a range of advanced technologies with human-centered design to develop a complex system that was shown to help patients with CHF. More psychological than physical benefits were observed. TRIAL REGISTRATION: ClinicalTrials.gov NCT03497871; https://clinicaltrials.gov/ct2/history/NCT03497871. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12872-018-0921-2.

Proof-of-concept trial results of the HeartMan mobile personal health system for self-management in congestive heart failure.

This study tested the effectiveness of HeartMan-a mobile personal health system offering decisional support for management of congestive heart failure (CHF)-on health-related quality of life (HRQoL), self-management, exercise capacity, illness perception, mental and sexual health. A randomized controlled proof-of-concept trial (1:2 ratio of control:intervention) was set up with ambulatory CHF patients in stable condition in Belgium and Italy. Data were collected by means of a 6-min walking test and a number of standardized questionnaire instruments. A total of 56 (34 intervention and 22 control group) participants completed the study (77% male; mean age 63 years, sd 10.5). All depression and anxiety dimensions decreased in the intervention group (p < 0.001), while the need for sexual counselling decreased in the control group (p < 0.05). Although the group differences were not significant, self-care increased (p < 0.05), and sexual problems decreased (p < 0.05) in the intervention group only. No significant intervention effects were observed for HRQoL, self-care confidence, illness perception and exercise capacity. Overall, results of this proof-of-concept trial suggest that the HeartMan personal health system significantly improved mental and sexual health and self-care behaviour in CHF patients. These observations were in contrast to the lack of intervention effects on HRQoL, illness perception and exercise capacity.

Sexual Activity in Heart Failure Patients: Information Needs and Association with Health-Related Quality of Life.

(1) Background: the main objective of this study was to investigate information needs concerning sexual activity and experienced sexual problems in heart failure (HF) patients and, in addition, to examine the association between these sexual problems and health-related quality of life (HRQoL); (2) Methods: in this cross-sectional study, three self-administered questionnaires were distributed to 77 stable ambulatory HF patients to acquire data on HRQoL, sexual problems, and need for counselling; (3) Results: More than half (56.7%) of HF patients experienced a marked decrease or total cessation of sexual activity due to their illness. Additionally, more than one-third perceived a marked decrease or total absence of sexual pleasure (42.5%), interest (32.9%), and constant problems or being unable to perform sexual activity (37.3%). Furthermore, 43.1% of patients experienced an important overall need for counselling concerning sexual activity, with information on relationships (69.2%), symptoms (58.5%), and relaxation (49.2%) being the most desired topics. Multiple linear regression analysis revealed that sexual problems were independently associated with HRQoL, with more sexual problems (t = 3.19, p < 0.01) being related to poor HRQoL; (4) Conclusion: by investigating the experienced problems and counselling needs of HF patients, an alignment between current practice and HF patients' expectations and needs might be obtained.

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

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.