Rheumatic DiseaseNCT05283096
Survey About Diet in Chronic Inflammatory Rheumatic Diseases
An observational study of Rheumatic Disease and Rheumatic Disorder, run by Poitiers University Hospital at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatic Disease, Rheumatic Disorder, Inflammatory Rheumatism
- What is being tested?
- Questionnaire
- How many people
- 203 participants
- Where
- 1 siteFrance
- Study dates
- 10 Feb 2022to 30 Sep 2022
- 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: 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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Rheumatic Disease, Rheumatic Disorder, Inflammatory Rheumatism, Rheumatoid Arthritis, Psoriatic Arthritis, Spondyloarthritis
- Being tested
- Questionnaire
- Keywords
- Survey, Questionnaire, Diet, Inflammatory Rheumatism
- Medical subject headings
- Rheumatic Diseases, Rheumatic Fever, Arthritis, Rheumatoid, Arthritis, Psoriatic, Spondylarthritis, Spondylitis, Ankylosing, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
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
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic inflammatory rheumatic disease | Not described Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence (rate) of patients with chronic inflammatory rheumatism who have changed their dietary practices since being diagnosed.
To assess the prevalence of dietary changes in patients with chronic inflammatory rheumatism (rheumatoid arthritis, spondylarthritis and psoriatic arthritis) using a questionnaire
Measured: 6 months
Secondary outcomes (6)
Rate of patients believing that diet affects their rheumatism
To describe the practices, knowledge and beliefs about diets of patients with chronic inflammatory rheumatism using a questionnaire
Measured: 6 months
Rate of patients following each specific diet (gluten free, vegetarian, dairy products free, ...)
To describe the practices, knowledge and beliefs about diets of patients with chronic inflammatory rheumatism using a questionnaire
Measured: 6 months
Comparison of the rates of patients believing that diet affects their rheumatism, between each subgroup of rheumatism
To compare dietary beliefs, knowledge and practices between different patient subgroups (rheumatoid arthritis, spondyloarthritis, psoriatic arthritis) with their answers to the questionnaire
Measured: 6 months
Comparison of the rates of patients following each specific diet (gluten free, vegetarian, dairy products free, ...) between each subgroup of rheumatism
To compare dietary beliefs, knowledge and practices between different patient subgroups (rheumatoid arthritis, spondyloarthritis, psoriatic arthritis) with their answers to the questionnaire
Measured: 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
To compare drug management and disease activity between different dietary practices (with and without practice modification) with their answers to the questionnaire
Measured: 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
To compare drug management and disease activity between different dietary practices (with and without practice modification) with their answers to the questionnaire
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 posted16 Mar 2022
- Study start10 Feb 2022
- Primary completion11 Apr 2022
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic DiseaseStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283096
- Sponsor's protocol ID
- ALIRIC
- Status last verified
- Mar 2022
- First submitted
- 5 Feb 2022
- Last updated
- 14 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Survey on Patients' Practices, Knowledge and Beliefs About Diet in Chronic Inflammatory Rheumatic Diseases (Rheumatoid Arthritis, Psoriatic Arthritis, Spondylarthritis)
- ClinicalTrials.gov ID
- NCT05283096
- Acronym / sponsor ID
- ALIRIC
- Conditions
- Rheumatic Disease, Rheumatic Disorder, Inflammatory Rheumatism, Rheumatoid Arthritis, Psoriatic Arthritis, Spondyloarthritis
- Keywords
- Survey, Questionnaire, Diet, Inflammatory Rheumatism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 11 Apr 2022 (actual)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 16 Mar 2022 (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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic inflammatory rheumatic disease | – | Other: Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| QuestionnaireA questionnaire about beliefs on food and diet in rheumatic diseases, and if a diet was tried what effect it had on health and rheumatism | Other | Patients with chronic inflammatory rheumatic disease |
Primary outcome
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 secondary outcomes
Rate of patients believing that diet affects their rheumatism
Time frame: 6 months
Rate of patients following each specific diet (gluten free, vegetarian, dairy products free, ...)
Time frame: 6 months
Comparison of the rates of patients believing that diet affects their rheumatism, between each subgroup of rheumatism
Time frame: 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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Individual participant dataSharing planned: Undecided
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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.
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 Rheumatic Disease and Rheumatic Disorder, run by Poitiers University Hospital 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 14 Jun 2022. 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?
Results are not available in the source record.
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?
Prevalence (rate) of patients with chronic inflammatory rheumatism who have changed their dietary practices since being diagnosed. (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 14 Jun 2022.