Patients in Complex SituationsQualsoprim_2NCT03886285
A Quality Rating Scale for Patients in Complex Situations
An observational study of Patients in Complex Situations, run by University Hospital, Brest at 12 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Patients in Complex Situations
- What is being tested?
- Questionnaire
- How many people
- 500 participants
- Where
- 12 sitesFrance
- Study dates
- 26 Jul 2019to 20 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient followed in the primary care center and being in a complex care situation, benefiting from a multi-professional care
Who may be able to join
- 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).
Who cannot join
- Patient not in a complex care situation
- Patient followed only by the general practitioner of GECO
- Refusal of participation
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Maison de santé d'Audierne
Audierne, 29770
Maison de santé de CAVAN
Cavan, 22140
Maison de santé de Gourin
Gourin, 56110
Pôle de santé de Lanmeur
Lanmeur, 29620
Maison de santé du Faou
Le Faou, 29590
Maison de santé du Vieux Marché
Le Vieux-Marché, 22420
Maison de santé de LOUARGAT
Louargat, 22540
Maison de santé de Milizac
Milizac, 29290
Maison de santé de Moëlan sur Mer
Moëlan-sur-Mer, 29350
Maison de santé de Pleyben
Pleyben, 29190
Maison de santé de Plouneour Trez
Plounéour-Trez, 29890
Maison de santé de Trébeurden
Trébeurden, 22560
About this study
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
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.
- Conditions
- Patients in Complex Situations
- Being tested
- Questionnaire
- Keywords
- Multimorbidity, Exercise coordinated groups (GECO), Caregivers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Completion of the questionnaire by the patient after consultation with the general practitioner
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start26 Jul 2019
- Primary completion20 Apr 2021
- Study completion20 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients in Complex SituationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03886285
- Sponsor's protocol ID
- 29BRC19.0019
- Acronym
- Qualsoprim_2
- Status last verified
- Jun 2021
- First submitted
- 20 Mar 2019
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03886285
- Acronym / sponsor ID
- Qualsoprim_2 / 29BRC19.0019
- Conditions
- Patients in Complex Situations
- Keywords
- Multimorbidity, Exercise coordinated groups (GECO), Caregivers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 26 Jul 2019 (actual)
- Primary completion
- 20 Apr 2021 (actual)
- Study completion
- 20 Apr 2021 (actual)
- First posted
- 22 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient followed in the primary care center and being in a complex care situation, benefiting from a multi-professional care
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (3 listed)
- Patient not in a complex care situation
- Patient followed only by the general practitioner of GECO
- Refusal of participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireCompletion of the questionnaire by the patient after consultation with the general practitioner | Other | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients in Complex Situations, run by University Hospital, Brest at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Construction of the questionnaire. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023.