- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03107299
Evaluation of the Impact of 3 Methods of Communication on the Adherence of Methotrexate in Patients With Rheumatoid Arthritis (METHO-PR)
Methotrexate (MTX) is the first-line treatment for rheumatoid arthritis (RA). Poor adherence of this treatment decreases the control of the disease and the effectiveness of the associated treatments.
The aim would be to study the observance of patients with RA and to be able to propose adequate solutions favoring patient compliance and thus the stability of the pathology.
For this purpose, 3 methods of communication have been put in place to encourage adherence: usual care by the rheumatologist, sms sending or pharmaceutical maintenance.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Vincent GOEB, PhD
- Phone Number: +33322668259
- Email: goeb.vincent@chu-amiens.fr
Study Locations
-
-
Picardie
-
Amiens, Picardie, France, 80054
- Recruiting
- CHU Amiens Picardie
-
Contact:
- Vincent GOEB, PhD
- Phone Number: +33322668259
- Email: goeb.vincent@chu-amiens.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult patients attending Day Hospital or consultation of rheumatology with rheumatoid polyarteritis and under treatment with MTX alone or in combination with another therapeutic, fixed dosage for at least 3 months.
- Consenting Patient
- Literate French-speaking patient,
- Patient with a mobile phone
- Patient affiliated to a social security scheme
Exclusion Criteria:
- Patient not managing his own treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Control
|
Prospective randomized controlled study in intention to treat in open monocentric in 3 arms: all patients benefiting from the current management (medical consultation every 4 to 6 months in the department of rheumatology)
|
Other: Send sms to patients
|
Prospective randomized controlled study in intention to treat in open monocentric in 3 arms: all patients benefiting from the current management (medical consultation every 4 to 6 months in the department of rheumatology)
|
Other: pharmaceutical maintenance following medical consultation
|
Prospective randomized controlled study in intention to treat in open monocentric in 3 arms: all patients benefiting from the current management (medical consultation every 4 to 6 months in the department of rheumatology)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
CQR19 (Compliance Questionnaire Rheumatology) Compliance Measurement Surveywith rheumatoid arthritis.
Time Frame: 10 months
|
10 months
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2016_843_0006
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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