Validation of the French Version of the CQR (Compliance Questionnaire Rheumatology)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Nīmes

About this trial

The purpose of this study is to develop a French language version of the Compliance-Questionnaire-Rheumatology for use in French and Francophone rheumatology services

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The patient must have given their free and informed consent and signed the consent form

The patient must be a member or beneficiary of a health insurance plan

The patient is at least 18 years old

The patient has rheumatoid polyarthritis as defined by the ACR-EULAR 2010 criteria, treated orally or subcutaneously with MTX for at least 3 months with a stable (unchanged) dosage for at least 1 month, and a stable (unchanged) route of administration for at least 1 month. And no planned change in Methotrexate intake at least until the second study visit. Other treatments at the same time are authorized

Disqualifiers

The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study

The subject refuses to sign the consent

It is impossible to give the subject informed information

The patient is under safeguard of justice or state guardianship

Trial population

Patients with rheumatoid polyarthritis as defined by the ACR-EULAR 2010 criteria, treated orally or subcutaneously with MTX for at least 3 months being followed in the rheumatology department of Montpellier, Toulouse, Bordeaux or Nîmes hospitals.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Questionnaire

    Other intervention

    Patients are asked to complete several questionnaires

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Patients with rheumatoid polyarthritis1 intervention

Trial outcomes

Primary outcomes

1

Test-retest agreement of French translation of the Compliance Questionnaire Rheumatology questionnaire

Intraclass correlation and Kappa coefficient of 2 evaluations taken 40 minutes apart

Time frame
40 minutes
2

Structural validity of French translation of the Compliance Questionnaire Rheumatology questionnaire

Principal component analysis

Time frame
Baseline

Secondary outcomes

1

Validation of the Compliance Questionnaire Rheumatology against gold standard (erythrocyte methotrexate polyglutamates (MTX PGs) concentration)

CQR ≥80% (observant) vs MTX PGs level

Time frame
Baseline
2

Rate of missing responses to each question of French translation of Compliance Questionnaire Rheumatology

%

Time frame
Baseline
3

Rate of questionnaires with at least 1 missing item

%

Time frame
Baseline
4

Validation of the short form of the French Compliance Questionnaire Rheumatology

5-item questionnaire

Time frame
Baseline

Other outcomes

Sponsors and contacts

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