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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • France
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients with chronic inflammatory rheumatic disease
Other: Questionnaire
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Poitiers University Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 10, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 11, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 14, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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