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

Rheumatoid Arthritis Clinical Trial

— ETP-PR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01564147
• Other study ID #: BRD/11/02-J
• Status: Terminated
• Phase: N/A
• First received: March 21, 2012
• Last updated: August 5, 2016
• Start date: September 2011
• Est. completion date: February 2012

Study information

• Verified date: August 2016
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France : AFSSAPS
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 62
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• immediate therapeutic education
Access to the course of immediate therapeutic education
• therapeutic education delayed
Group receiving therapeutic education 6 months later (control group)

Locations

Country	Name	City	State
France	Maugars	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EVA measures the overall ability to find solutions applicable to their situation	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	No
Secondary	EVA measures the ability to find solutions applicable to their situation for each of the three problems identified.	Ability to find solutions applicable to their situation for each of the three problems identified	12 months	No
Secondary	Knowledge (score / 10) treatments for rheumatoid arthritis, knowledge (note/10) signs of a flare of rheumatoid arthritis.	Skills that we consider indispensable	12 months	No
Secondary	Self-efficacy against a disease flare (EVA), self-efficacy against a side effect of treatment (EVA)	Perceived self-efficacy compared to rheumatoid arthritis	12 months	No
Secondary	RAPID score 4 (scale)	Scalability of rheumatoid arthritis	12 months	No
Secondary	EVA measuring fatigue	Fatigue	12 months	No
Secondary	Duration of morning stiffness in minutes or hours.	Duration of stiffness	12 months	No
Secondary	CRP and VS	Biological criteria	12 months	No
Secondary	Scale of STAI S Scale of STAI S	Anxiety	12 months	No
Secondary	Beck Scale	Depression	12 months	No
Secondary	Evaluation Test of adherence of Girerd	Observance	12 months	No
Secondary	Dosage Cortancyl or Solupred.	Use of steroids	12 months	No
Secondary	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...	Consumption of medical and paramedical	12 months	No
Secondary	Patient satisfaction with respect to information received, the caller and the improvement in different areas of health (EVA)	Satisfaction with patient education	12 months	No
Secondary	Attendance at meetings / workshops offered after the initial diagnosis.	Membership	12 months	No