PREventive Care Infrastructure based On Ubiquitous Sensing (PRECIOUS): A Study Protocol

Background mHealth has experienced a huge growth during the last decade. It has been presented as a new and promising pathway to increase self-management of health and chronic conditions in several populations. One of the most prolific areas of mHealth has been healthy lifestyles promotion. However, few mobile apps have succeeded in engaging people and ensuring sustained use. Objective This paper describes the pilot test protocol of the PReventive Care Infrastructure based on Ubiquitous Sensing (PRECIOUS) project, aimed at validating the PRECIOUS system with end users. This system includes, within a motivational framework, the Bodyguard2 sensor (accelerometer with heart rate monitoring) and the PRECIOUS app. Methods This is a pilot experimental study targeting morbidly obese prediabetic patients who will be randomized to three conditions: (1) Group 1 - Control group (Treatment as usual with the endocrinologist and the nurse + Bodyguard2), (2) Group 2 - PRECIOUS system (Bodyguard2 + PRECIOUS app), and (3) Group 3 - PRECIOUS system (Bodyguard2 + PRECIOUS app + Motivational Interviewing). The duration of the study will be 3 months with scheduled follow-up appointments within the scope of the project at Weeks 3, 5, 8, and 12. During the study, several measures related to healthy lifestyles, weight management, and health-related quality of life will be collected to explore the effectiveness of PRECIOUS to foster behavior change, as well as user acceptance, usability, and satisfaction with the solution. Results Because of the encouraging results shown in similar scientific work analyzing health apps acceptance in clinical settings, we expect patients to widely accept and express satisfaction with PRECIOUS. We also expect to find acceptable usability of the preventive health solution. The recruitment of the pilot study has concluded with the inclusion of 31 morbidly obese prediabetic patients. Results are expected to be available in mid-2017. Conclusions Adopting and maintaining healthy habits may be challenging in people with chronic conditions who usually need regular support to ensure mid/long-term adherence to recommendations and behavior change. Thus, mHealth could become a powerful and efficient tool since it allows continuous communication with users and immediate feedback. The PRECIOUS system is an innovative preventive health care solution aimed at enhancing inner motivation from users to change their lifestyles and adopt healthier habits. PRECIOUS includes ubiquitous sensors and a scientifically grounded app to address three main components of health: physical activity, diet, and stress levels. Trial Registration Clinicaltrials.gov NCT02818790; https://clinicaltrials.gov/ct2/show/NCT02818790 (Archived by WebCite at http://www.webcitation.org/6qfzdfMoU)

PRECIOUS: PREventive Care Infrastructure based On Ubiquitous Sensing will provide a preventive care system to promote healthy lifestyles, which is comprised of three components: (1) transparent sensors for monitoring user context and health indicators (food intake, sleep and activity) deliver ambient data about current user behavior; (2) users are represented by individual virtual models which allow inferring health risks and desired behavioral changes; (3) state-of-the-art motivational techniques (originating especially from gamification and motivational interview ) trigger a set of feedback tools to change the user habits toward more healthy conduct. While related projects usually focus on developing specific sensors, middleware solutions, health monitoring systems, eHealth services, etc., both the individual virtual model and the associated motivational tools will now provide key innovation steps towards a preventive care system with measurable impact on user behavior and thus a clear potential for large scale commercialization and sustainable societal footprint (e.g. with respect to cost saving in the public health sector as well as life quality improvements). To reach these goals, PRECIOUS consortium gathers partners from academia, SMEs and hospitals with comprehensive expertise in networking, pervasive sensing, cognitive analysis, nutrition research, semantic technologies and motivational techniques. We have chosen to focus on type II diabetes as a central use case, while our prototype will be easily adaptable also to other lifestyle-induced diseases. The system will not only detect and communicate detailed early warning signs, but also provide forecasts of future developments and associated problems (if change recommendations are not followed).
Extensive lab-and field-based user trials will demonstrate the efficacy of the PRECIOUS system and prove its positive and lasting impact on individual quality of life as well as public health sector development.

Evaluation :
1.Scientific and/or technological excellence (relevant to the topics addressed by the call) ( Threshold 3.0/5 ; Weight 1.00 ) Mark: The proposal addresses target 5.1.a. very well in all aspects.
The proposal is aiming to provide a preventive care system to promote healthy lifestyles, with a high quality sensing platform, virtual models, and a motivational system. The concept is very sound, very well structured, focussed and described, and its related objectives are very good.
The state of the art is profoundly described. The envisioned system will be based on state of the art technology in addition to new methodologies of motivational interviews, and it will build follow-up mechanisms with medical experts. Key innovations are related to both the individual virtual model and the associated motivational tools with measurable impact on user behaviour.
The theoretical framework is well elaborated and presented. The small scale pilot and field tests are well designed. However, the monitoring of the food intake is not described in sufficient detail.

2.Quality and efficiency of the implementation and the management ( Threshold 3.0/5 ; Weight 1.00 ) Mark:
The management plan, structure and procedures are adequate.
The quality of individual participants is very good, and they have relevant experience.
The consortium is a well-balanced mixture of academic and research institutions, and SMEs, with complementary expertise.
The planned budget is well prepared and relevant. The allocation of resources is appropriate and justified.
The risk and contingency plan is excellent.

3.Potential impact through the development, dissemination and use of project results ( Threshold 3.0/5 ; Weight 1.00 ) Mark:
The proposal will contribute to the expected impacts very well. Improving lifestyle changes will decrease the need for medical intervention, and could have a significant economic impact. Commercialization of the envisioned results could lead to organization of novel effective preventive care services with measurable impact on user behaviour.
The proposal has a general, yet adequate dissemination plan, which includes the specific dissemination plans of most participants.
The overall exploitation plan is realistic, but lacks some details related to the implementation of the service. An exploitation plan is proposed by most partners.