More Added Value of Therapeutic Education in the Management of Patients With Rheumatoid Arthritis (ETP-PR) (ETP-PR)

August 5, 2016 updated by: Nantes University Hospital

More Added Value of Therapeutic Education in the Management of Patients With Rheumatoid Arthritis

Taking into account the recommendations of the Health Authority [1] and the application of patients' associations, we have structured a course of therapeutic education includes three stages for patients with rheumatoid arthritis and followed at Nantes University Hospital. Step 1: initial interview with a nurse patient education for diagnosis and education with the patient to choose three subjects from among 10 offered him problematic; Step 2: Orientation in an educational path that provides access to 6 months group workshops (3 maximum) and / or interviews tailored to the three selected topics; Step 3: final interview with a nurse said therapeutic education formative assessment to take stock. The main objective of our work is to ensure that the patient finds it easier solutions to the three problematic topics him after 6 months of education after six months without treatment.

Study Overview

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

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

      • Nantes, France, 44000
        • Maugars

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient presenting at clinics for Rheumatology or the Rheumatology Day Hospital at the University Hospital or hospitalized in the department of Rheumatology
  • Men or women
  • Having signed the consent
  • major
  • Affiliated to social security or covered by the CMU
  • Patient with rheumatoid arthritis meeting the ACR criteria
  • Patient with rheumatoid arthritis stable for at least 6 months (change in DAS 28 <1.2)

Exclusion Criteria:

  • Patient can not understand the information
  • Patient confined to bed or chair, unable to care for himself or not doing with difficulty
  • pregnant patient
  • minors
  • Adults under guardianship

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Immediate Education therapeutic
Access to the course of immediate therapeutic education
Access to the course of immediate therapeutic education
Other: therapeutic education delayed
Group receiving therapeutic education 6 months later (control group)
Group receiving therapeutic education 6 months later (control group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EVA measures the overall ability to find solutions applicable to their situation
Time Frame: 12 months
Investigate whether, overall, the patient is more easily applicable solutions to the situation after six months of therapeutic education after six months without therapeutic education for three problems identified after the initial filling of the questionnaire (controls ) and after the initial interview with the nurse (test group)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EVA measures the ability to find solutions applicable to their situation for each of the three problems identified.
Time Frame: 12 months
Ability to find solutions applicable to their situation for each of the three problems identified
12 months
Knowledge (score / 10) treatments for rheumatoid arthritis, knowledge (note/10) signs of a flare of rheumatoid arthritis.
Time Frame: 12 months
Skills that we consider indispensable
12 months
Self-efficacy against a disease flare (EVA), self-efficacy against a side effect of treatment (EVA)
Time Frame: 12 months
Perceived self-efficacy compared to rheumatoid arthritis
12 months
RAPID score 4 (scale)
Time Frame: 12 months
Scalability of rheumatoid arthritis
12 months
EVA measuring fatigue
Time Frame: 12 months
Fatigue
12 months
Duration of morning stiffness in minutes or hours.
Time Frame: 12 months
Duration of stiffness
12 months
CRP and VS
Time Frame: 12 months
Biological criteria
12 months
Scale of STAI S Scale of STAI S
Time Frame: 12 months
Anxiety
12 months
Beck Scale
Time Frame: 12 months
Depression
12 months
Evaluation Test of adherence of Girerd
Time Frame: 12 months
Observance
12 months
Dosage Cortancyl or Solupred.
Time Frame: 12 months
Use of steroids
12 months
Number of visits to physician, rheumatologist at at therapist, psychiatrist, occupational physician, number of hospitalizations, number of meetings with occupational therapist, social worker, dietician, physiotherapist, psychologist...
Time Frame: 12 months
Consumption of medical and paramedical
12 months
Patient satisfaction with respect to information received, the caller and the improvement in different areas of health (EVA)
Time Frame: 12 months
Satisfaction with patient education
12 months
Attendance at meetings / workshops offered after the initial diagnosis.
Time Frame: 12 months
Membership
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Yves Maugars, PU-PH, CHU de Nantes

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

September 1, 2011

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

March 21, 2012

First Submitted That Met QC Criteria

March 23, 2012

First Posted (Estimate)

March 27, 2012

Study Record Updates

Last Update Posted (Estimate)

August 8, 2016

Last Update Submitted That Met QC Criteria

August 5, 2016

Last Verified

August 1, 2016

More Information

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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