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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05057520
Other study ID # 29BRC21.0009
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 24, 2021
Est. completion date February 6, 2023

Study information

Verified date July 2023
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 250
Est. completion date February 6, 2023
Est. primary completion date February 6, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Questionnaire
Completion of the questionnaire by the patient after consultation with the general practitioner

Locations

Country Name City State
France Maison de santé de Bannalec Bannalec
France Maison de santé de Châteauneuf-du-Faou Châteauneuf-du-Faou
France Maison de santé de Coray Coray
France Pôle de santé de Lanmeur Lanmeur
France Maison de santé de Trébeurden Trébeurden

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Concurrent validity of questionnaire Test the concurrent validity by comparison with EUROPEP questionnaire to verify that it does indeed measure the latent trait it is supposed to measure. The EUROPEP questionnaire is a 23-item validated and internationally standardized measure of patient evaluations of general practice care. 1 day
Secondary Anchor variables Test anchor variables that can be used later to assess sensitivity to change (comparison of means test if the candidate variable is qualitative and Spearman correlation if it is quantitative). 1 day
Secondary Standardized scoring guide To construct a standardized scoring guide if a satisfactory questionnaire is obtained. 1 day
See also
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Completed NCT02934711 - A Quality Rating Scale for Patients in Complex Situations and Their Caregivers
Completed NCT03886285 - A Quality Rating Scale for Patients in Complex Situations