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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01564147
First received: March 21, 2012
Last updated: June 11, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Rheumatoid Arthritis
Other: immediate therapeutic education
Other: therapeutic education delayed

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: More Added Value of Therapeutic Education in the Management of Patients With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • EVA measures the overall ability to find solutions applicable to their situation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • EVA measures the ability to find solutions applicable to their situation for each of the three problems identified. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Ability to find solutions applicable to their situation for each of the three problems identified

  • Knowledge (score / 10) treatments for rheumatoid arthritis, knowledge (note/10) signs of a flare of rheumatoid arthritis. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Skills that we consider indispensable

  • Self-efficacy against a disease flare (EVA), self-efficacy against a side effect of treatment (EVA) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Perceived self-efficacy compared to rheumatoid arthritis

  • RAPID score 4 (scale) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Scalability of rheumatoid arthritis

  • EVA measuring fatigue [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Fatigue

  • Duration of morning stiffness in minutes or hours. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Duration of stiffness

  • CRP and VS [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Biological criteria

  • Scale of STAI S Scale of STAI S [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Anxiety

  • Beck Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Depression

  • Evaluation Test of adherence of Girerd [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Observance

  • Dosage Cortancyl or Solupred. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Use of steroids

  • 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 ] [ Designated as safety issue: No ]
    Consumption of medical and paramedical

  • Patient satisfaction with respect to information received, the caller and the improvement in different areas of health (EVA) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Satisfaction with patient education

  • Attendance at meetings / workshops offered after the initial diagnosis. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Membership


Enrollment: 62
Study Start Date: September 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Immediate Education therapeutic
Access to the course of immediate therapeutic education
Other: immediate therapeutic education
Access to the course of immediate therapeutic education
therapeutic education delayed
Group receiving therapeutic education 6 months later (control group)
Other: therapeutic education delayed
Group receiving therapeutic education 6 months later (control group)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01564147

Locations
France
Maugars
Nantes, France, 44000
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Yves Maugars, PU-PH CHU de Nantes
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01564147     History of Changes
Other Study ID Numbers: 11/02-J
Study First Received: March 21, 2012
Last Updated: June 11, 2013
Health Authority: France : AFSSAPS

Keywords provided by Nantes University Hospital:
Therapeutic Education, Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 15, 2014