Previously submitted to: JMIR mHealth and uHealth (no longer under consideration since Apr 01, 2019)
Date Submitted: Sep 28, 2018
Open Peer Review Period: Oct 6, 2018 - Dec 1, 2018
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Safe and Easy Environment for frailty syndrome: a randomized controlled trial at patient home.
Background:
All over the world the increasing prevalence of age-related disorders such as Alzheimer’s disease (AD) and frailty and its impact on functional decline is challenging the sustainability of health care systems. In the field of AD and related disorders, Information and Communication technologies (ICT) showed promising results in improving clinical assessment and implementing interventions to delay functional decline and decrease the burden of behavioral symptoms.
Objective:
The SafEE (Safe Easy Environment) project, is a collaborative French-Taiwanese project aiming to develop: 1/ an ICT-based behavior analysis platform able to automatically detect, recognize and assess daytime and nighttime behavioral patterns, and 2/ adapted tailored non pharmacological interventions. Partners of the projects include clinicians, research engineers and industrials.
Methods:
This study was designed as a randomized controlled trial. We recruited 3 patients with cognitive frailty syndrome [≥ 60 years, MMSE ≥ 26, CDR ≤ 0.5] randomized either to the intervention group (ICT-based therapeutic solutions, N=1) or to the control group (care as usual, N=2). The 6-month intervention included detection of daytime and nighttime behaviors based on 2D and 3D video cameras (for both groups), and tailored therapeutic solutions based on serious-games, aromatherapy and music therapy for the intervention group. The primary outcome is the acceptability of the solutions measured by the frequency of use and self-reports. The secondary outcome is the solution efficacy, measured by the results on neuropsychological tests.
Results:
This project made it possible to develop a communicating platform between the automatic recognition of activity and the non-pharmacological solutions developed. This platform is thus able to 1) provide healthcare professionals with continuous feedback on immediate and long-term risk events; 2) Automatically combine an online assessment with non-pharmacological interventions that can act on the detected disorders; 3) obtain relevant information in the context of an early diagnosis at home of frail people at risk of developing Alzheimer's disease.
Conclusions:
Building a global system aiming to detect and prevent loss of autonomy in frail people is a rather complicated task, involving numerous ICT solutions which are not always easy to use in everyday life. The innovation of the project lies in a new methodological approach to deal with care of elderly people, based on an innovative use of ICT based on the association of assessment and intervention for specific cognitive and behavioral patterns. The results of this trial may have important implications for future interventions, and provide relevant information for the general transferability of this platform as part of the AD prevention.
ClinicalTrial:
ClinicalTrials.gov, NCT02288221. First received: August 19, 2014. Last updated: November 7, 2014. Last verified: June 2014.
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