Accepted for/Published in: JMIR Research Protocols
Date Submitted: Mar 20, 2020
Date Accepted: Jun 25, 2020
Date Submitted to PubMed: Jul 8, 2020
Warning: This is an author submission that is not peer-reviewed or edited.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.
Toi Même: A mHealth Platform for Measuring Bipolar Illness Activity – Feasibility Study Protocol
ABSTRACT
Background:
Bipolar disorder (BD) is a chronic illness associate with increased rates of premature mortality and dementia. Patients with BD frequently present mood instability likely associated with risk of relapse, impaired functioning, and suicidal behavior, indicating that the illness is active.
Objective:
This 3-month feasibility study, carried out in a real-world clinical setting, aims to evaluate the relevance of digital self-assessment of mood/behavior in bipolar patients using a smartphone app Toi Même. This study also aims to investigate possible correlations between clinically rated mood symptoms and subjective/objective smartphone data in BD.
Methods:
The Toi Même mHealth platform was built up to self-monitoring mood/behavior, assess risk of relapse, and predict response to treatment in BD, comprising an electronic health records for the study investigators and the Toi Même app for patients. This open label, prospective, multicentric trial will enroll 93 (31 depressive, 31 euthymic, and 31 hypo-manic) adult bipolar patients with a diagnosis of a BD type I/II (DSM-5 criteria), and having an iPhone (iOS version from 9.x). Participants self-monitoring mood/behavior using the Toi Même app and also are evaluated by psychiatrists at baseline, 2-week, 1-month, 2-month and 3-mont study period.
Results:
The patients’ enrollment has started in mid-2018 and the estimation for the study completion is end-2021. The first results for publication are expected throughout 2020. The transfer of technology from the academic environment to the clinics may be a strategy to invigorate efforts making available Toi Même mHealth platform for BD patients.
Conclusions:
The Toi Même feasibility study is an example of use of digital technology in BD clinical practice that may give us more precise, fine-grained mood/behavioral patterns of BD activity. This clinical neuroscience-based research may add to the evidence of exploring other alternatives towards a more integrative approach, including digital data, for the development of a clinically meaningful framework for investigating and treating BD. Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT03508427
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