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Accepted for/Published in: JMIR Medical Informatics

Date Submitted: Oct 2, 2020
Date Accepted: Jan 11, 2021

The final, peer-reviewed published version of this preprint can be found here:

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

Luštrek M, Bohanec M, Cavero Barca C, Ciancarelli MC, Clays E, Dawodu AA, Derboven J, De Smedt D, Dovgan E, Lampe J, Marino F, Mlakar M, Pioggia G, Puddu PE, Rodríguez JM, Schiariti M, Slapničar G, Slegers K, Tartarisco G, Valič J, Vodopija A

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

JMIR Med Inform 2021;9(3):e24501

DOI: 10.2196/24501

PMID: 33666562

PMCID: 7980114

Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.

Self-Management of Congestive Heart Failure: HeartMan Personal Health System and Its Evaluation

  • Mitja Luštrek; 
  • Marko Bohanec; 
  • Carlos Cavero Barca; 
  • Maria Costanza Ciancarelli; 
  • Els Clays; 
  • Amos Adeyemo Dawodu; 
  • Jan Derboven; 
  • Delphine De Smedt; 
  • Erik Dovgan; 
  • Jure Lampe; 
  • Flavia Marino; 
  • Miha Mlakar; 
  • Giovanni Pioggia; 
  • Paolo Emilio Puddu; 
  • Juan Mario Rodríguez; 
  • Michele Schiariti; 
  • Gašper Slapničar; 
  • Karin Slegers; 
  • Gennaro Tartarisco; 
  • Jakob Valič; 
  • Aljoša Vodopija

ABSTRACT

Background:

Congestive heart failure (CHF) is a disease requiring complex management involving multiple medications, exercise and lifestyle changes. It mainly affects older patients, often suffering from depression and anxiety, who commonly find the management difficult. Existing mobile applications supporting self-management of CHF have limited features and are inadequately validated.

Objective:

The objective of the HeartMan project was to develop a personal health system that would comprehensively address CHF self-management by utilizing sensing devices and artificial-intelligence methods. This paper presents the design of the system and reports on the accuracy of the patient-monitoring methods, the overall effectiveness and the patient perceptions.

Methods:

A mobile application was developed as the core of the HeartMan system, 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 human-centered methodology, involving the patients throughout the development. It was evaluated in a proof-of-concept trial with 56 patients.

Results:

A fairly high accuracy of the patient-monitoring methods was observed. The mean absolute error of BP estimation was 9.0 mmHg for systolic BP and 7.0 mmHg for diastolic BP. The accuracy of psychological profile detection was 88.6 %. The F-measure of 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 < 0.05), while depression and anxiety rates were significantly reduced (p < 0.001), as were the perceived sexual problems (p < 0.05). According to the Unified Theory of Acceptance and Use of Technology questionnaire, a positive attitude towards HeartMan was seen among end-users, resulting in increasing 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 CHF patients. More psychological than physical benefits were observed. Clinical Trial: ClinicalTrials.gov, NCT03497871, 2018-04-13


 Citation

Please cite as:

Luštrek M, Bohanec M, Cavero Barca C, Ciancarelli MC, Clays E, Dawodu AA, Derboven J, De Smedt D, Dovgan E, Lampe J, Marino F, Mlakar M, Pioggia G, Puddu PE, Rodríguez JM, Schiariti M, Slapničar G, Slegers K, Tartarisco G, Valič J, Vodopija A

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

JMIR Med Inform 2021;9(3):e24501

DOI: 10.2196/24501

PMID: 33666562

PMCID: 7980114

Per the author's request the PDF is not available.