NCT01564147

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Sep 2011

Shorter than P25 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 27, 2012

Completed
Last Updated

August 8, 2016

Status Verified

August 1, 2016

Enrollment Period

5 months

First QC Date

March 21, 2012

Last Update Submit

August 5, 2016

Conditions

Rheumatoid Arthritis

Keywords

Therapeutic Education, Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (14)

  • EVA measures the 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.

    12 months

  • Self-efficacy against a disease flare (EVA), self-efficacy against a side effect of treatment (EVA)

    12 months

  • RAPID score 4 (scale)

    12 months

  • EVA measuring fatigue

    12 months

  • +9 more secondary outcomes

Study Arms (2)

Immediate Education therapeutic

OTHER

Access to the course of immediate therapeutic education

Other: immediate therapeutic education

therapeutic education delayed

OTHER

Group receiving therapeutic education 6 months later (control group)

Other: therapeutic education delayed

Interventions

immediate therapeutic educationOTHER

Access to the course of immediate therapeutic education

Immediate Education therapeutic
therapeutic education delayedOTHER

Group receiving therapeutic education 6 months later (control group)

therapeutic education delayed

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maugars

Nantes, 44000, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Yves Maugars, PU-PH

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2012

First Posted

March 27, 2012

Study Start

September 1, 2011

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

August 8, 2016

Record last verified: 2016-08

Locations

FR(1)