NCT05385666

Brief Summary

Frequent mental disorders (anxiety or mood disorders), an important part of primary care patient care, remain insufficiently detected and treated. Improving their care requires better coordination between general practice and specialized care. The collaborative care model developed in Washington State with the introduction of a care manager is recognized. About 100 randomized controlled trials have established its effectiveness and efficiency, in terms of improving the progression of disorders (remission rate), adherence, quality of life, professional and patient satisfaction, and cost savings. However, the possibility of implementation of these validated care remains to be explored. A dozen collaborative care implementation studies exist, all conducted in the USA and not having considered all the dimensions of the indicators of penetration, acceptability/adoption, feasibility, fidelity and cost. A first implementation in France is implemented since September 2021 in the Yvelines department on four sites of different size, organization and environments: the multi-professional health centers (MSP) of Mureaux and Celle St Cloud, the Chevreuse medical house and MG in isolated practice in Versailles. The main objective of the research project is to evaluate the first implementation in France of collaborative care for frequent psychic disorders according to the indicators of penetration, acceptability/adoption, fidelity, relevance, feasibility and cost.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2022

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 23, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

July 13, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2022

Enrollment Period

1.8 years

First QC Date

May 12, 2022

Last Update Submit

August 22, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • to evaluate the first implementation in France of collaborative care for frequent psychic disorders

    numbers of patients and medical caregivers who participate in collaborative care

    36 months

Study Arms (1)

group experimental

EXPERIMENTAL
Other: collaborative cares

Interventions

coordinate care between city medicine and specialized psychiatric care to improve the management of common mental disorders

group experimental

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthcare professionals involved in the collaborative care system
  • patients who have been referred for collaborative care by their family physician

You may not qualify if:

  • patient refusal to participate in research
  • adults protected by law

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Maison de Santé Pluridisciplinaire

Chevreuse, 78460, France

RECRUITING

Maison de Santé Pluridisciplinaire

Les Mureaux, 78130, France

RECRUITING

Cabinet Médical Versailles

Versailles, 78000, France

RECRUITING

cabinet médical Versailles

Versailles, 78000, France

RECRUITING

Cabinet Médical Versailles

Versailles, 78000, France

NOT YET RECRUITING

MeSH Terms

Conditions

Mental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Investigator Coordinator

Study Record Dates

First Submitted

May 12, 2022

First Posted

May 23, 2022

Study Start

July 13, 2022

Primary Completion

May 1, 2024

Study Completion

May 1, 2025

Last Updated

August 25, 2022

Record last verified: 2022-08

Locations