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

5. august 2016 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

62

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Nantes, Frankrig, 44000
        • Maugars

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
EVA measures the overall ability to find solutions applicable to their situation
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
EVA measures the ability to find solutions applicable to their situation for each of the three problems identified.
Tidsramme: 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.
Tidsramme: 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)
Tidsramme: 12 months
Perceived self-efficacy compared to rheumatoid arthritis
12 months
RAPID score 4 (scale)
Tidsramme: 12 months
Scalability of rheumatoid arthritis
12 months
EVA measuring fatigue
Tidsramme: 12 months
Fatigue
12 months
Duration of morning stiffness in minutes or hours.
Tidsramme: 12 months
Duration of stiffness
12 months
CRP and VS
Tidsramme: 12 months
Biological criteria
12 months
Scale of STAI S Scale of STAI S
Tidsramme: 12 months
Anxiety
12 months
Beck Scale
Tidsramme: 12 months
Depression
12 months
Evaluation Test of adherence of Girerd
Tidsramme: 12 months
Observance
12 months
Dosage Cortancyl or Solupred.
Tidsramme: 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...
Tidsramme: 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)
Tidsramme: 12 months
Satisfaction with patient education
12 months
Attendance at meetings / workshops offered after the initial diagnosis.
Tidsramme: 12 months
Membership
12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Nantes University Hospital

Efterforskere

  • Ledende efterforsker: Yves Maugars, PU-PH, Chu de Nantes

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2011

Primær færdiggørelse (Faktiske)

1. februar 2012

Studieafslutning (Faktiske)

1. februar 2012

Datoer for studieregistrering

Først indsendt

21. marts 2012

Først indsendt, der opfyldte QC-kriterier

23. marts 2012

Først opslået (Skøn)

27. marts 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

8. august 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. august 2016

Sidst verificeret

1. august 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BRD/11/02-J

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Rheumatoid arthritis

Kliniske forsøg med immediate therapeutic education

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Guatemala

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner