- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00623922
Effect of Patient Education in Rheumatic Diseases
The Effect of Patient Education on Coping and Well Being in Patients With Arthritis.
The purpose of this study is to explore the effect of patient education (PE) in patients with arthritis. PE has become a task that is dictated by law in Norway, and is increasingly used as an element in the treatment of patients with chronic complaints. Our hypothesis is that
- PE delivered as group education, followed by an individual nurse consultation increases the patients wellbeing an ability to cope with the disease.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Trondheim, Norge, 7489
- Norwegian University of Science and Technology and St. Olavs Hospital HF
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Polyarthritis
- 18-80 years
- native Norwegian speaking
- able to understand and participate in the PE program
Exclusion Criteria:
- Participated in a patient educational program the latest 12 months
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: 2
Sædvanlig pleje
|
|
|
Eksperimentel: 1
Patient education
|
3 group meetings followed by 1-2 individual nurse consultations.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Self efficacy
Tidsramme: Baseline, 4 and 12 months
|
Baseline, 4 and 12 months
|
|
Well being (Arizona Integrative Outcomes Scale)
Tidsramme: Baseline, 4 and 12 months
|
Baseline, 4 and 12 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Arthritis Impact Measurement Scale 2 (affect, symptoms, social interaction, role)
Tidsramme: Baseline, 4 and 12 months
|
Baseline, 4 and 12 months
|
|
The Hospital Anxiety and Depression Scale
Tidsramme: Baseline, 4 and 12 months
|
Baseline, 4 and 12 months
|
|
Educational Needs Assessment Tools
Tidsramme: Baseline, 4 and 12 months
|
Baseline, 4 and 12 months
|
|
Modified Health Assessment Questionnaire
Tidsramme: Baseline, 4 and 12 months
|
Baseline, 4 and 12 months
|
|
DAS 28 score (Disease activity score)
Tidsramme: Baseline, 4 and 12 months
|
Baseline, 4 and 12 months
|
|
Patient Activation Measurement (PAM)
Tidsramme: Baseline, 4 and 12 months
|
Baseline, 4 and 12 months
|
|
Cost- benefit
Tidsramme: Baseline, 4 and 12 months
|
Baseline, 4 and 12 months
|
|
Physical activity
Tidsramme: Baseline, 4 and 12 months
|
Baseline, 4 and 12 months
|
|
Use of medications
Tidsramme: Baseline, 4 and 12 months
|
Baseline, 4 and 12 months
|
|
fatigue (VAS scale)
Tidsramme: Baseline, 4 and 12 months
|
Baseline, 4 and 12 months
|
|
Pain (VAS scale)
Tidsramme: Baseline, 4 and 12 months
|
Baseline, 4 and 12 months
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Aslak Steinsbekk, Norwegian University of Science and Technology
- Ledende efterforsker: Kjersti Grønning, Norwegian University of Science and Technology
Publikationer og nyttige links
Generelle publikationer
- Riemsma RP, Taal E, Kirwan JR, Rasker JJ. Systematic review of rheumatoid arthritis patient education. Arthritis Rheum. 2004 Dec 15;51(6):1045-59. doi: 10.1002/art.20823. No abstract available.
- Gronning K, Skomsvoll JF, Rannestad T, Steinsbekk A. The effect of an educational programme consisting of group and individual arthritis education for patients with polyarthritis--a randomised controlled trial. Patient Educ Couns. 2012 Jul;88(1):113-20. doi: 10.1016/j.pec.2011.12.011. Epub 2012 Jan 23.
- Gronning K, Rannestad T, Skomsvoll JF, Rygg LO, Steinsbekk A. Long-term effects of a nurse-led group and individual patient education programme for patients with chronic inflammatory polyarthritis - a randomised controlled trial. J Clin Nurs. 2014 Apr;23(7-8):1005-17. doi: 10.1111/jocn.12353. Epub 2013 Jul 22.
- Gronning K, Midttun L, Steinsbekk A. Patients' confidence in coping with arthritis after nurse-led education; a qualitative study. BMC Nurs. 2016 May 4;15:28. doi: 10.1186/s12912-016-0150-x. eCollection 2016.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 4.2007.2472
- NSD 17975
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 .
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