- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05613712
Chronic Inflammatory Rheumatism: Management of Comorbidities in Ambulatory Medicine (SCORIC-A)
March 24, 2023 updated by: University Hospital, Grenoble
Identification of factors limiting compliance with the recommendations established during the evaluation of the SCORIC population by the rheumatology department of the CHU Grenoble Alpes
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
In the rheumatology department of the CHU Grenoble Alpes, Professor Baillet and other rheumatologists have set up a holistic assessment of inflammatory rheumatism (rheumatoid arthritis, spondyloarthritis and psoriatic arthritis) and associated co-morbidities in a day hospital.
Based on this assessment, a hospital report is drawn up summarising the patient's treatment options, which is then sent to the patient's referring physician.
They analysed the first 100 patients in the cohort and showed that 98% of patients were not up to date with their care.
Their longitudinal analysis shows that patients update two thirds of the recommendations made within 12 to 18 months.
Therefore, the investigators would like to assess the applicability of this screening in these patients, through a questionnaire sent to the 400 patients of the cohort and to their treating physicians.
Study Type
Observational
Enrollment (Anticipated)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Athan BAILLET, PU-PH
- Phone Number: 0476767082
- Email: abaillet@chu-grenoble.fr
Study Locations
-
-
-
Grenoble, France, 38043
- Recruiting
- CHU Grenoble Alpes
-
Contact:
- Xavier ROMAND, Phd
- Phone Number: 0476769291
- Email: xromand@chu-grenoble.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The SCORIC population targeted by the patient questionnaire represents all patients followed by the rheumatology department of the CHU Grenoble Alpes, having benefited from a holistic analysis of their disease and their comorbidities.
The referring physician population will be generated from the medical records of the patients of the SCORIC cohort.
Description
Inclusion Criteria:
- Patient cohort :
- men and women over 18 years of age
- Informed volunteers who have consented to participate in the study
- have rheumatoid arthritis, spondyloarthritis or psoriatic arthritis
- have been hospitalised in a day hospital in the rheumatology department of the Grenoble-Alpes University = SCORIC cohort of the department
- Cohort of referring physicians :
- volunteers who received informed information and consented to participate in the study
- be the referring physician of a patient of the SCORIC cohort of the rheumatology department of the South Hospital of the CHU Grenoble-Alpes
Exclusion Criteria:
- Patient cohort :
- psychiatric pathologies or history of behavioural disorders
- persons referred to in articles L1121-5 to L1121-8 of the Public Health Code
- persons under guardianship or curatorship
- not affiliated to the social security system
- minors
- Refusal to participate by the patient and/or unreturned questionnaire
- Cohort of referring physicians:
- the physician is no longer the patient's referring physician
- refusal of the doctor to participate and/or questionnaire not returned
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients
Patients followed by the rheumatology department of the CHU Grenoble Alpes, constituting the SCORIC group
|
Description by the patients through the questionnaire of the elements limiting the good ambulatory follow-up
|
Referring physician
Physicians identified as the referring physician for patients in the SCORIC group
|
Description by the referring physicians through the questionnaire of the elements limiting the applicability of the recommendations issued by the rheumatology department of the CHU Grenoble Alpes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identification of the factors limiting compliance with the recommendations established during the evaluation of the SCORIC population by the rheumatology department of the CHU Grenoble Alpes, through questionnaires
Time Frame: 1 day
|
Identification of the factors limiting compliance with the recommendations established during the evaluation of the SCORIC population by the rheumatology department of the CHU Grenoble Alpes
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Elements limiting the good ambulatory follow-up, according to the patients
Time Frame: 1 day
|
Description by the patients through the questionnaire of the elements limiting the good ambulatory follow-up
|
1 day
|
Elements limiting the applicability of the recommendations issued by the rheumatology department of the CHU Grenoble Alpes, according to the patients
Time Frame: 1 day
|
Description by the referring physicians through the questionnaire of the elements limiting the applicability of the recommendations issued by the rheumatology department of the CHU Grenoble Alpes
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Xavier ROMAND, PHD, CHU Grenoble Alpes
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 11, 2023
Primary Completion (Anticipated)
February 11, 2024
Study Completion (Anticipated)
February 11, 2024
Study Registration Dates
First Submitted
November 4, 2022
First Submitted That Met QC Criteria
November 4, 2022
First Posted (Actual)
November 14, 2022
Study Record Updates
Last Update Posted (Actual)
March 28, 2023
Last Update Submitted That Met QC Criteria
March 24, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 38RC22.0355
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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