NCT03886285

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
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

12 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

March 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

July 26, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2021

Completed
Last Updated

August 24, 2023

Status Verified

June 1, 2021

Enrollment Period

1.7 years

First QC Date

March 20, 2019

Last Update Submit

August 23, 2023

Conditions

Keywords

MultimorbidityExercise coordinated groups (GECO)Caregivers

Outcome Measures

Primary Outcomes (1)

  • Construction of the questionnaire.

    The main objective of this phase of the protocol is to structure the questionnaire in order to achieve a scale of assessment of the quality of primary care provided within the coordinated exercise groups from the point of view of complex care patients, their caregivers and patients and health professionals. This questionnaire doesn't exist so it has no name.This questionnaire is qualitative and not quantitative, so nos score is expected.

    1 day

Interventions

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

Eligibility Criteria

Age18 Years - 90 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:

  • Patient followed in the primary care center, able to participate, speaking and understanding French, and being in a complex care situation, benefiting from a multi-professional care (at least two professionals different from the center including the general practitioner).

You may not qualify if:

  • Patient not in a complex care situation
  • Patient followed only by the general practitioner of GECO
  • Refusal of participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Maison de santé d'Audierne

Audierne, 29770, France

Location

Maison de santé de CAVAN

Cavan, 22140, France

Location

Maison de santé de Gourin

Gourin, 56110, France

Location

Pôle de santé de Lanmeur

Lanmeur, 29620, France

Location

Maison de santé du Faou

Le Faou, 29590, France

Location

Maison de santé du Vieux Marché

Le Vieux-Marché, 22420, France

Location

Maison de santé de LOUARGAT

Louargat, 22540, France

Location

Maison de santé de Milizac

Milizac, 29290, France

Location

Maison de santé de Moëlan sur Mer

Moëlan-sur-Mer, 29350, France

Location

Maison de santé de Pleyben

Pleyben, 29190, France

Location

Maison de santé de Plouneour Trez

Plounéour-Trez, 29890, 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

March 20, 2019

First Posted

March 22, 2019

Study Start

July 26, 2019

Primary Completion

April 20, 2021

Study Completion

April 20, 2021

Last Updated

August 24, 2023

Record last verified: 2021-06

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 Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations