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NOT YET RECRUITING
NCT07211984
NA

Evaluation of Dalia Solution For Depressed Patient

Sponsor: Dalia Care

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

OTHER

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