A Quality Rating Scale for Patients in Complex Situations (Qualsoprim_2)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03886285 |
|
Recruitment Status :
Completed
First Posted : March 22, 2019
Last Update Posted : June 30, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Patients in Complex Situations | Other: Questionnaire |
| Study Type : | Observational |
| Actual Enrollment : | 500 participants |
| Observational Model: | Other |
| Time Perspective: | Prospective |
| Official Title: | Establish a Scale of Assessment of the Quality of Primary Care in Multi-functional Health Centers and Homes Integrating the Point of View of Complex Patients and Their Caregivers |
| Actual Study Start Date : | July 26, 2019 |
| Actual Primary Completion Date : | April 20, 2021 |
| Actual Study Completion Date : | April 20, 2021 |
- Other: Questionnaire
Completion of the questionnaire by the patient after consultation with the general practitioner
- Construction of the questionnaire. [ Time Frame: 1 day ]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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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).
Exclusion Criteria:
- Patient not in a complex care situation
- Patient followed only by the general practitioner of GECO
- Refusal of participation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03886285
| France | |
| Maison de santé d'Audierne | |
| Audierne, France, 29770 | |
| Maison de santé de CAVAN | |
| Cavan, France, 22140 | |
| Maison de santé de Gourin | |
| Gourin, France, 56110 | |
| Pôle de santé de Lanmeur | |
| Lanmeur, France, 29620 | |
| Maison de santé du Faou | |
| Le Faou, France, 29590 | |
| Maison de santé du Vieux Marché | |
| Le Vieux Marche, France, 22420 | |
| Maison de santé de LOUARGAT | |
| Louargat, France, 22540 | |
| Maison de santé de Milizac | |
| Milizac, France, 29290 | |
| Maison de santé de Moëlan sur Mer | |
| Moëlan-sur-Mer, France, 29350 | |
| Maison de santé de Pleyben | |
| Pleyben, France, 29190 | |
| Maison de santé de Plouneour Trez | |
| Plouneour Trez, France, 29890 | |
| Maison de santé de Trébeurden | |
| Trebeurden, France, 22560 | |
| Responsible Party: | University Hospital, Brest |
| ClinicalTrials.gov Identifier: | NCT03886285 |
| Other Study ID Numbers: |
29BRC19.0019_Qualsoprim_2 |
| First Posted: | March 22, 2019 Key Record Dates |
| Last Update Posted: | June 30, 2021 |
| Last Verified: | June 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | All collected data that underlie results in a publication |
| Supporting Materials: |
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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Multimorbidity Exercise coordinated groups (GECO) Caregivers |