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Evaluation of Dalia Solution For Depressed Patient

NCT07211984 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 644

Last updated 2025-10-08

No results posted yet for this study

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

Conditions

  • Depression Chronic
  • Depressed
  • Depressed Mood
  • Depression and Quality of Life
  • Depression Diagnosis

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.

Sponsors & Collaborators

  • Dalia Care

    lead INDUSTRY

Principal Investigators

  • Stéphane Mouchabac, Doctor · Dalia Care

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
76 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-10
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07211984 on ClinicalTrials.gov