- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01564147
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
Status
Terminated
Conditions
Intervention / Treatment
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.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BRD/11/02-J
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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