Back to resultsEvaluation of the Impact of 3 Methods of Communication on the Adherence of Methotrexate in Patients With Rheumatoid Arthritis (METHO-PR)
Primary Purpose
Methotrexate, Polyarthritis; Rheumatoid
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Communication methods to encourage adherence
Sponsored by
About this trial
This is an interventional prevention trial for Methotrexate
Eligibility Criteria
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
Sites / Locations
- CHU Amiens PicardieRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Control
Send sms to patients
pharmaceutical maintenance following medical consultation
Arm Description
Outcomes
Primary Outcome Measures
CQR19 (Compliance Questionnaire Rheumatology) Compliance Measurement Surveywith rheumatoid arthritis.
Secondary Outcome Measures
Full Information
NCT ID
NCT03107299
First Posted
March 31, 2017
Last Updated
April 10, 2017
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT03107299
Brief Title
Evaluation of the Impact of 3 Methods of Communication on the Adherence of Methotrexate in Patients With Rheumatoid Arthritis
Acronym
METHO-PR
Official Title
Evaluation of the Impact of 3 Methods of Communication on the Adherence of Methotrexate in Patients With Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
July 1, 2017 (Anticipated)
Study Completion Date
July 1, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Methotrexate, Polyarthritis; Rheumatoid
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Other
Arm Title
Send sms to patients
Arm Type
Other
Arm Title
pharmaceutical maintenance following medical consultation
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Communication methods to encourage adherence
Intervention Description
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)
Primary Outcome Measure Information:
Title
CQR19 (Compliance Questionnaire Rheumatology) Compliance Measurement Surveywith rheumatoid arthritis.
Time Frame
10 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vincent GOEB, PhD
Phone
+33322668259
Email
goeb.vincent@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens Picardie
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent GOEB, PhD
Phone
+33322668259
Email
goeb.vincent@chu-amiens.fr
12. IPD Sharing Statement
Citations:
PubMed Identifier
30192070
Citation
Mary A, Boursier A, Desailly Henry I, Grados F, Sejourne A, Salomon S, Fardellone P, Brazier M, Goeb V. Mobile Phone Text Messages and Effect on Treatment Adherence in Patients Taking Methotrexate for Rheumatoid Arthritis: A Randomized Pilot Study. Arthritis Care Res (Hoboken). 2019 Oct;71(10):1344-1352. doi: 10.1002/acr.23750.
Results Reference
derived
Learn more about this trial
Evaluation of the Impact of 3 Methods of Communication on the Adherence of Methotrexate in Patients With Rheumatoid Arthritis
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