Patients in Complex SituationsQualSoPrimNCT02934711
A Quality Rating Scale for Patients in Complex Situations and Their Caregivers
An observational study of Patients in Complex Situations, run by University Hospital, Brest at 1 site in France.
Trial summary
Identify and analyze in the exercise groups coordinated (GECO) the effects of coordination arrangements between professionals on the transformation of modes of exercise of professional care, and on the experience of patients / users and that of caregivers, particularly on dimensions constituted that the quality of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients in Complex Situations
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 20 Mar 2017to 24 Jan 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In each of exercise coordinated groups (GECO), it will be important to obtain a variety of cases studied in terms of socio-demographic characteristics (although populations of the basins of different exercise coordinated groups may have more or less specific profiles, to be taken into account) and range previous care. The population of multimorbid patients and caregivers will be vary with regard to age, sex, place of residence (living alone or cohabiting with relatives or hosted) and professional categories
Who may be able to join
- For Professionals:
- Medical or paramedical professionals working in the exercise coordinated groups (GECO) initially defined
- Professionals who made his non_opposition
- For patients and family caregivers:
- Binomials patients / caregivers over the age of 18.
- Binomials patients / caregivers who formulated his non_opposition
- Patients experiencing complex care (multi-morbid and chronic)
Who cannot join
- Refusal of a participant (Professionals / Patients / caregivers) to respond to inquiries
Trial locations and contacts
1 site in 1 country.
France1 site
Maison de santé de l'Aulne Maritime du Faou
Le Faou, France, 29590
About this study
Official title: Establish a Quality Rating Scale for Primary Care Centers and Nursing Homes Pluri Professionals Integrating the Perspective of Patients in Complex Situations and Their Caregivers
Identify and analyze in the exercise groups coordinated (GECO) the effects of coordination arrangements between professionals on the transformation of modes of exercise of professional care, and on the experience of patients / users and that of caregivers, particularly on dimensions constituted that the quality of care in order to build a coordinated exercise structures rating scale primary care on the basis of criteria suggested by patients
- Conditions
- Patients in Complex Situations
- Keywords
- Multimorbidity, Exercise coordinated groups (GECO), Caregivers
What is being measured
The primary outcome is the main question the study is designed to answer.
A quality assessment scale
Perform a quality assessment scale for primary care in the exercise coordinated groups (GECO) of perspective in complex situations patients, their caregivers and healthcare professionals
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study start20 Mar 2017
- Primary completion24 Jan 2018
- Study completion24 Jan 2018
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.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- 50 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
- NCT02934711
- Sponsor's protocol ID
- 29BRC16.0144
- Acronym
- QualSoPrim
- Status last verified
- Apr 2019
- First submitted
- 13 Oct 2016
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establish a Quality Rating Scale for Primary Care Centers and Nursing Homes Pluri Professionals Integrating the Perspective of Patients in Complex Situations and Their Caregivers
- ClinicalTrials.gov ID
- NCT02934711
- Acronym / sponsor ID
- QualSoPrim / 29BRC16.0144
- Conditions
- Patients in Complex Situations
- Keywords
- Multimorbidity, Exercise coordinated groups (GECO), Caregivers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 24 Jan 2018 (actual)
- Study completion
- 24 Jan 2018 (actual)
- First posted
- 17 Oct 2016 (estimated)
- 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.
Identify and analyze in the exercise groups coordinated (GECO) the effects of coordination arrangements between professionals on the transformation of modes of exercise of professional care, and on the experience of patients / users and that of caregivers, particularly on dimensions constituted that the quality of care in order to build a coordinated exercise structures rating scale primary care on the basis of criteria suggested by patients
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In each of exercise coordinated groups (GECO), it will be important to obtain a variety of cases studied in terms of socio-demographic characteristics (although populations of the basins of different exercise coordinated groups may have more or less specific profiles, to be taken into account) and range previous care. The population of multimorbid patients and caregivers will be vary with regard to age, sex, place of residence (living alone or cohabiting with relatives or hosted) and professional categories
Key inclusion criteria (7 listed)
- For Professionals:
- Medical or paramedical professionals working in the exercise coordinated groups (GECO) initially defined
- Professionals who made his non_opposition
- For patients and family caregivers:
- Binomials patients / caregivers over the age of 18.
Key exclusion criteria (1 listed)
- Refusal of a participant (Professionals / Patients / caregivers) to respond to inquiries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
A quality assessment scale
Time frame: 18 months
Perform a quality assessment scale for primary care in the exercise coordinated groups (GECO) of perspective in complex situations patients, their caregivers and healthcare professionals
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 21 Sep 2023.
- Individual participant dataSharing planned: No
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.
1 site 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 1 site 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 7 inclusion and 1 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 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
A quality assessment scale (time frame: 18 months). 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 21 Sep 2023.