NCT05057520

Brief Summary

The prevalence of multimorbid patients and complex care is increasing in France and elsewhere in the world. It concerns 60% of the over 65 years old. Comprehensive care, the involvement of the patient and his caregivers appear as the solutions for the management of these new care situations. The structures of multi-professional grouping, developing a coordinated exercise (GECO), appear as the privileged place to take care of these patients. These structures become the main place of exercise in France (improved working conditions for professionals, financial incentives, public policy, etc.); they have shown their ability to formulate patient care protocols, to produce coordinated exercise, to better involve the patient and caregivers in their care. The question of improving the quality of care arises. To date, there is no data on the subject apart from some evaluations mainly medico-economic. The patient's place in the evaluation showed his interest with the existence of a proven correlation between patient satisfaction in particular and his compliance and health outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

5 active sites

Status
completed

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

September 16, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 27, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

November 24, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2023

Completed
Last Updated

July 14, 2023

Status Verified

July 1, 2023

Enrollment Period

1.2 years

First QC Date

September 16, 2021

Last Update Submit

July 13, 2023

Conditions

Keywords

MultimorbidityExercise coordinated groups (GECO)Caregivers

Outcome Measures

Primary Outcomes (1)

  • Reliability of questionnaire

    The main objective of this phase of the protocol is to confirm on an independent sample the reliability of the primary care quality assessment questionnaire scales provided within the coordinated exercise groups from the point of view of patients in complex care situations, their caregivers and health professionals.

    1 day

Secondary Outcomes (3)

  • Concurrent validity of questionnaire

    1 day

  • Anchor variables

    1 day

  • Standardized scoring guide

    1 day

Interventions

Completion of the questionnaire by the patient after consultation with the general practitioner

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient followed in the primary care center and being in a complex care situation, benefiting from a multi-professional care

You may qualify if:

  • Patients over 18 years of age, followed in primary care centers, able to participate, speaking and understanding French,
  • Patient in a complex care situation, benefiting from a multi-professional management (at least two different professionals from the center including the general practitioner),
  • No opposition from the patient.

You may not qualify if:

  • Patient not in a complex care situation
  • Patient followed only by the the exercise coordinated group general practitioner
  • Refusal to participate
  • Patients who have already participated in phase 2 of the Qualsoprim project
  • Adults under legal protection or unable to express their consent
  • Persons deprived of their liberty by a judicial or administrative decision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Maison de santé de Bannalec

Bannalec, 29380, France

Location

Maison de santé de Châteauneuf-du-Faou

Châteauneuf-du-Faou, 29520, France

Location

Maison de santé de Coray

Coray, 29370, France

Location

Pôle de santé de Lanmeur

Lanmeur, 29620, France

Location

Maison de santé de Trébeurden

Trébeurden, 22560, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2021

First Posted

September 27, 2021

Study Start

November 24, 2021

Primary Completion

February 6, 2023

Study Completion

February 6, 2023

Last Updated

July 14, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available beginning five years and ending fifteen years following the final study report completion
Access Criteria
Data access requests will be reviewed by the internal committee of BrestUH. Requestors will be required to sign and complete a data access agreement.

Locations