- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05283096
Survey About Diet in Chronic Inflammatory Rheumatic Diseases
June 11, 2022 updated by: Poitiers University Hospital
French Survey on Patients' Practices, Knowledge and Beliefs About Diet in Chronic Inflammatory Rheumatic Diseases (Rheumatoid Arthritis, Psoriatic Arthritis, Spondylarthritis)
A French Survey on patients' practices, knowledge and beliefs about diet in chronic inflammatory rheumatic diseases (rheumatoid arthritis, psoriatic arthritis, spondylarthritis) Use of a questionnaire about what patients have heard concerning diet and rheumatism, what kind of diet they tried eventually and how it affected their health and disease
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
203
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nouvelle Aquitaine
-
Poitiers, Nouvelle Aquitaine, France, 86000
- CHU Poitiers
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients followed in the rheumatology department of the University Hospital of Poitiers (France) for chronic inflammatory rheumatism, going for consultation or hospitalisation for usual care
Description
Inclusion Criteria:
- Age ≥ 18 years
- Patient with chronic inflammatory rheumatism (rheumatoid arthritis, spondylarthritis, psoriatic arthritis) according to the diagnostic criteria commonly admitted
- Patient followed in the rheumatology department of the University Hospital of Poitiers (France)
- Free patient, without guardianship or tutelage or subordination
- Patient not opposing to participate in the study
Exclusion Criteria:
- Patient withdrawing consent
- Patient who does not meet criteria for chronic inflammatory disease (rheumatoid arthritis, spondylarthritis, psoriatic arthritis) according to the diagnostic criteria commonly admitted after examination of medical record
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with chronic inflammatory rheumatic disease
|
A questionnaire about beliefs on food and diet in rheumatic diseases, and if a diet was tried what effect it had on health and rheumatism
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence (rate) of patients with chronic inflammatory rheumatism who have changed their dietary practices since being diagnosed.
Time Frame: 6 months
|
To assess the prevalence of dietary changes in patients with chronic inflammatory rheumatism (rheumatoid arthritis, spondylarthritis and psoriatic arthritis) using a questionnaire
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of patients believing that diet affects their rheumatism
Time Frame: 6 months
|
To describe the practices, knowledge and beliefs about diets of patients with chronic inflammatory rheumatism using a questionnaire
|
6 months
|
Rate of patients following each specific diet (gluten free, vegetarian, dairy products free, ...)
Time Frame: 6 months
|
To describe the practices, knowledge and beliefs about diets of patients with chronic inflammatory rheumatism using a questionnaire
|
6 months
|
Comparison of the rates of patients believing that diet affects their rheumatism, between each subgroup of rheumatism
Time Frame: 6 months
|
To compare dietary beliefs, knowledge and practices between different patient subgroups (rheumatoid arthritis, spondyloarthritis, psoriatic arthritis) with their answers to the questionnaire
|
6 months
|
Comparison of the rates of patients following each specific diet (gluten free, vegetarian, dairy products free, ...) between each subgroup of rheumatism
Time Frame: 6 months
|
To compare dietary beliefs, knowledge and practices between different patient subgroups (rheumatoid arthritis, spondyloarthritis, psoriatic arthritis) with their answers to the questionnaire
|
6 months
|
Comparison of the rates of patients who were able to stop a part of their treatment between the diet and non-diet groups
Time Frame: 6 months
|
To compare drug management and disease activity between different dietary practices (with and without practice modification) with their answers to the questionnaire
|
6 months
|
Comparison of disease activity by the level of C reactive protein, DAS 28, ASDAS and BASDAI between the diet and non-diet groups
Time Frame: 6 months
|
To compare drug management and disease activity between different dietary practices (with and without practice modification) with their answers to the questionnaire
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 10, 2022
Primary Completion (Actual)
April 11, 2022
Study Completion (Anticipated)
September 30, 2022
Study Registration Dates
First Submitted
February 5, 2022
First Submitted That Met QC Criteria
March 8, 2022
First Posted (Actual)
March 16, 2022
Study Record Updates
Last Update Posted (Actual)
June 14, 2022
Last Update Submitted That Met QC Criteria
June 11, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Infections
- Immune System Diseases
- Autoimmune Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Connective Tissue Diseases
- Bacterial Infections
- Bacterial Infections and Mycoses
- Streptococcal Infections
- Gram-Positive Bacterial Infections
- Skin Diseases, Papulosquamous
- Spinal Diseases
- Bone Diseases
- Spondylarthropathies
- Spondylarthritis
- Psoriasis
- Bone Diseases, Infectious
- Ankylosis
- Arthritis
- Arthritis, Rheumatoid
- Arthritis, Psoriatic
- Rheumatic Diseases
- Collagen Diseases
- Spondylitis
- Spondylitis, Ankylosing
- Rheumatic Fever
Other Study ID Numbers
- ALIRIC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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