MultimorbidityNCT03116061
The Reported Frequency of FP Visits and Family Difficulties Should Alert FPs and Help Them to Prevent Severe Outcomes in Multimorbid Outpatients
An observational study of Multimorbidity, run by University Hospital, Brest.
Trial summary
The European General Practitioners Research Network (EGPRN) designed and validated a comprehensive definition of multimorbidity using a systematic literature review and qualitative research throughout Europe. This definition was tested as a model to assess decompensation in multimorbid outpatients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multimorbidity
- What is being tested?
- Questionnaire
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Dec 2016
- 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: The study population included a random sample of multimorbid patients (according to the EGPRN definition of multimorbidity). Patients were selected by 19 FPs in their offices in the county of Finistere (in north-west France) from July 2014 to December 2014.
Who may be able to join
- Inclusion criteria were patients meeting the criteria for the definition of multimorbidity according to the EGPRN definition: any combination of chronic disease with at least one other disease (acute or chronic) or a bio psychosocial factor (associated or not) or a somatic risk factor.
Who cannot join
- Exclusion criteria were patients not meeting the criteria of the definition of multimorbidity, the inability to follow the study over time (known to be leaving the practice in the following months), patients under legal protection, outpatients in palliative care for whom survival was estimated by the FPs at less than three months.
About this study
Official title: The Frequency of Family Physician Visits and the Extent of Family Difficulties Reported by Family Physicians Appear to be Decompensation Risk Factors for Multimorbid Outpatients in a Primary Care Feasibility Study
The European General Practitioners Research Network (EGPRN) designed and validated a comprehensive definition of multimorbidity using a systematic literature review and qualitative research throughout Europe. This definition was tested as a model to assess decompensation in multimorbid outpatients.
The objective is to assess which criteria in the EGPRN concept of multimorbidity could detect decompensating outpatients in a primary care cohort at a 6-month follow-up and to assess whether a large scale cohort with FPs would be feasible.
Read the detailed description
Method: Family Physicians included a random sample of multimorbid patients who attended appointments in their offices from July to December 2014. Inclusion criteria were those of the EGPRN definition of Multimorbidity. Exclusion criteria were patients under legal protection and those unable to complete the 2-year follow-up. Decompensation was defined as the occurrence of death or hospitalization for more than seven days. Statistical analysis was undertaken with uni- and multivariate analysis at a 6-month follow-up using a combination of approaches including both automatic classification and expert decision making. A Multiple Correspondence Analysis (MCA) confirmed results consistency and completed the process with a projection of illustrative variables. A logistic regression was finally performed in order to identify and quantify risk factors for decompensation.
- Conditions
- Multimorbidity
- Being tested
- Questionnaire
- Keywords
- Multimorbidity, Family Medicine, decompensation, predictive value
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
This questionnaire was to explore potential decompensation risk factors within themes and subthemes of multimorbidity
| Study group | Role | What they receive |
|---|---|---|
| Multimorbidity cohort | The study population included a random sample of multimorbid patients (according to the EGPRN definition of multimorbidity). Patients were selected by 19 FPs in their offices in the county of Finistere (in north-west France) from July 2014 to December 2014. Randomization was achieved by including the first four multimorbid patients (according to the inclusion criteria) encountered during their second working day of each week. As patients were booking their appointments with the practice without the FPs' clearance, the FPs were not able to select them Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
To detect the decompensating outpatients
To assess which criteria in the EGPRN concept of multimorbidity could detect decompensating outpatients in a primary care cohort at a 6-month follow-up and to assess whether a large scale cohort with FPs would be feasible
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study startJul 2014
- Primary completionDec 2014
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MultimorbidityStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Collaborators
- ERCR SPURBO
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03116061
- Sponsor's protocol ID
- SPURBO
- Status last verified
- Feb 2025
- First submitted
- 10 Apr 2017
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Frequency of Family Physician Visits and the Extent of Family Difficulties Reported by Family Physicians Appear to be Decompensation Risk Factors for Multimorbid Outpatients in a Primary Care Feasibility Study
- ClinicalTrials.gov ID
- NCT03116061
- Acronym / sponsor ID
- SPURBO
- Conditions
- Multimorbidity
- Keywords
- Multimorbidity, Family Medicine, decompensation, predictive value
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- ERCR SPURBO
- Study start
- Jul 2014 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 14 Apr 2017 (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 European General Practitioners Research Network (EGPRN) designed and validated a comprehensive definition of multimorbidity using a systematic literature review and qualitative research throughout Europe. This definition was tested as a model to assess decompensation in multimorbid outpatients.
The objective is to assess which criteria in the EGPRN concept of multimorbidity could detect decompensating outpatients in a primary care cohort at a 6-month follow-up and to assess whether a large scale cohort with FPs would be feasible.
Detailed description
Method: Family Physicians included a random sample of multimorbid patients who attended appointments in their offices from July to December 2014. Inclusion criteria were those of the EGPRN definition of Multimorbidity. Exclusion criteria were patients under legal protection and those unable to complete the 2-year follow-up. Decompensation was defined as the occurrence of death or hospitalization for more than seven days. Statistical analysis was undertaken with uni- and multivariate analysis at a 6-month follow-up using a combination of approaches including both automatic classification and expert decision making. A Multiple Correspondence Analysis (MCA) confirmed results consistency and completed the process with a projection of illustrative variables. A logistic regression was finally performed in order to identify and quantify risk factors for decompensation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multimorbidity cohort | – | Other: QuestionnaireThe study population included a random sample of multimorbid patients (according to the EGPRN definition of multimorbidity). Patients were selected by 19 FPs in their offices in the county of Finistere (in north-west France) from July 2014 to December 2014. Randomization was achieved by including the first four multimorbid patients (according to the inclusion criteria) encountered during their second working day of each week. As patients were booking their appointments with the practice without the FPs' clearance, the FPs were not able to select them |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population included a random sample of multimorbid patients (according to the EGPRN definition of multimorbidity). Patients were selected by 19 FPs in their offices in the county of Finistere (in north-west France) from July 2014 to December 2014.
Key inclusion criteria (1 listed)
- Inclusion criteria were patients meeting the criteria for the definition of multimorbidity according to the EGPRN definition: any combination of chronic disease with at least one other disease (acute or chronic) or a bio psychosocial factor (associated or not) or a somatic risk factor.
Key exclusion criteria (1 listed)
- Exclusion criteria were patients not meeting the criteria of the definition of multimorbidity, the inability to follow the study over time (known to be leaving the practice in the following months), patients under legal protection, outpatients in palliative care for whom survival was estimated by the FPs at less than three months.
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 |
|---|---|---|
| QuestionnaireThis questionnaire was to explore potential decompensation risk factors within themes and subthemes of multimorbidity | Other | Multimorbidity cohort |
Primary outcome
To detect the decompensating outpatients
Time frame: 6 months
To assess which criteria in the EGPRN concept of multimorbidity could detect decompensating outpatients in a primary care cohort at a 6-month follow-up and to assess whether a large scale cohort with FPs would be feasible
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 4 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Multimorbidity, run by University Hospital, Brest.
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 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 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
To detect the decompensating outpatients (time frame: 6 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 4 Feb 2025.