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Evaluation of Dalia Solution For Depressed Patient
Sponsor: Dalia Care
Summary
The goal of this superiority clinical investigation, prospective, multicenter, controlled, randomized, open-label is to evaluate the clinical impact of the Dalia medical telemonitoring device on the management of depressive patients. The main question it aims to answer is: the percentage of patients with clinically significant improvement at 3 months. A clinically significant improvement is defined as a decrease of at least 5 points from the initial PHQ-9 score AND/OR a PHQ-9 score lower than 15. The threshold of 5 points is the Minimal Clinically Important Difference (MCID) of the PHQ-9 scale
Official title: Evaluation of the Clinical and Organizational Impact of the Digital Medical Device Dalia in the Management of Depression
Key Details
Gender
All
Age Range
18 Years - 76 Years
Study Type
INTERVENTIONAL
Enrollment
644
Start Date
2025-10-10
Completion Date
2026-03-31
Last Updated
2025-10-08
Healthy Volunteers
No
Conditions
Interventions
Dalia Monitoring
All patients consulting psychiatrists and general practitioners in participating centers, meeting all eligibility criteria and agreeing to participate in the study, will be consecutively selected and randomized into one of the two groups. For iInterventional arm: Patients will benefit from Dalia telemonitoring, in addition to conventional care.
Conventional healthcare
All patients consulting psychiatrists and general practitioners in participating centers, meeting all eligibility criteria and agreeing to participate in the study, will be consecutively selected and randomized into one of the two groups. For Control arm: Patients in this group will benefit from the conventional care pathway.
Locations (1)
Neurostim Luxembourg
Paris, France