Development of Cognitive and Physical Exercise Systems, Clinical Recordings, Large-Scale Data Analytics, and Virtual Coaching for Heart Failure Patients: Protocol for the BioTechCOACH-ForALL Project
Authors: Billis Antonis , Pandria Niki , Mouratoglou Sophia-Anastasia , Konstantinidis Evdokimos , Bamidis Panagiotis 
Published: March 2020

Background
Heart failure is a chronic disease affecting patient morbidity and mortality. Current guidelines for heart failure patient treatment are focused on improving their clinical status, functional capacity, and quality of life. However, these guidelines implement numerous instructions including medical treatment adherence, physical activity, and self-care management. The complexity of the therapeutic instructions makes them difficult to follow especially by older adults.

Objective
The challenge of this project is to (1) measure real-life adherence to a regular physical exercise program and (2) attempt to influence older adult patients with heart failure toward embracing a more physically active self-care lifestyle.

Methods
This research consists of two studies, including a lab experiment and a pragmatic evaluation of technology at patients’ homes. The lab experiment aims at exploring in an objective way (measuring neurophysiological responses to stimuli) patient engagement with different characteristics of virtual agents, while the home study is a 3-phase prospective study where the developed technology platform is tested by heart failure patients in their own home environments. Patients undergo evaluation of their physical activity and cognitive status using standard evaluation methods (6-minute walk test, questionnaires) and receive wearable devices to accurately measure everyday life activity levels (home study phases 1-3). During home study phases 2 and 3, exergames (serious games for physical exercise) to provide a physical exercise plan as a joyful activity are delivered to patients’ private households and e-coaching techniques are implemented in the final phase (home study phase 3) of the protocol, to influence patient attitudes toward a more healthy and recommended lifestyle.

Results
The trial is still ongoing. Recruitment is ongoing, and the project has progressed for some participants through phase 2 of the home study. The sample size for both studies is 28 participants; 10 have already been included in the study, and both baseline clinical and patient-reported outcome data are retrieved. Phases 2 and 3 of the home pilot study are expected to be completed within 6 months.

Conclusions
The main challenge of the project is the change of attitude of older age heart failure patients through an e-coaching system. Given the adoption of a cocreation and living lab approach and the main objective for real-life evaluation, the project is ready to react to any collected feedback, even during the implementation of the research plan. Clinical assessment and objective evaluation are expected to provide all required information for reliable findings.

Trial Registration
ClinicalTrials.gov NCT03877328; https://clinicaltrials.gov/ct2/show/NCT03877328

International Registered Report Identifier (IRRID)
DERR1-10.2196/17714