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METHO-PR: Evaluation of the Impact of 3 Methods of Communication on the Adherence of Methotrexate in Patients With Rheumatoid Arthritis

Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Unknown status
CT.gov ID
NCT03107299
Collaborator
(none)
150
Enrollment
1
Location
3
Arms
12
Anticipated Duration (Months)
12.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Communication methods to encourage adherence
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Evaluation of the Impact of 3 Methods of Communication on the Adherence of Methotrexate in Patients With Rheumatoid Arthritis
Actual Study Start Date :
Jul 1, 2016
Anticipated Primary Completion Date :
Jul 1, 2017
Anticipated Study Completion Date :
Jul 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Other: Control

Other: Communication methods to encourage adherence
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

Other: Communication methods to encourage adherence
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

Other: Communication methods to encourage adherence
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)

Outcome Measures

Primary Outcome Measures

  1. CQR19 (Compliance Questionnaire Rheumatology) Compliance Measurement Surveywith rheumatoid arthritis. [10 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Amiens Picardie Amiens Picardie France 80054

Sponsors and Collaborators

  • Centre Hospitalier Universitaire, Amiens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT03107299
Other Study ID Numbers:
  • PI2016_843_0006
First Posted:
Apr 11, 2017
Last Update Posted:
Apr 11, 2017
Last Verified:
Apr 1, 2017
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Arthritis

Study Results

No Results Posted as of Apr 11, 2017