Clinical trial NCT00623922: Effect of Patient Education in Rheumatic Diseases
Official title: The Effect of Patient Education on Coping and Well Being in Patients With Arthritis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polyarthritis
Keywords: Patient education
Nurse consultation
Arthritis
Wellbeing
Coping
Health related quality of life
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
First posted: 2008-02-26
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: There has been a rather long tradition of PE for patients with arthritis. A recent systematic review found that PE had small short-term effects on disability, joint counts, patient global assessment, psychological status and depression, but this effect disappeared on the latest time of follow up (3-14 months). A recent large British study also failed to show an effect on pain, physical functioning, or contact with primary care after 12 months, but found a significant effect on anxiety and improved the participants' perceived self efficacy. This indicates that the present forms of interventions fails to show a long term effect. One possible reason for the lack of long term effect might be that these interventions are given to groups only. Patients seem to prefer one-to-one interaction regarding information about the disease and its treatment together with emotional aspects, while education in groups are preferred for physical training and relational topics.

Eligibility criteria: 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

Primary outcomes:
measure: Self efficacy
timeFrame: Baseline, 4 and 12 months
measure: Well being (Arizona Integrative Outcomes Scale)
timeFrame: Baseline, 4 and 12 months
Secondary outcomes:
measure: Arthritis Impact Measurement Scale 2 (affect, symptoms, social interaction, role)
timeFrame: Baseline, 4 and 12 months
measure: The Hospital Anxiety and Depression Scale
timeFrame: Baseline, 4 and 12 months
measure: Educational Needs Assessment Tools
timeFrame: Baseline, 4 and 12 months
measure: Modified Health Assessment Questionnaire
timeFrame: Baseline, 4 and 12 months
measure: DAS 28 score (Disease activity score)
timeFrame: Baseline, 4 and 12 months
measure: Patient Activation Measurement (PAM)
timeFrame: Baseline, 4 and 12 months
measure: Cost- benefit
timeFrame: Baseline, 4 and 12 months
measure: Physical activity
timeFrame: Baseline, 4 and 12 months
measure: Use of medications
timeFrame: Baseline, 4 and 12 months
measure: fatigue (VAS scale)
timeFrame: Baseline, 4 and 12 months
measure: Pain (VAS scale)
timeFrame: Baseline, 4 and 12 months
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology and St. Olavs Hospital HF
Study officials:
affiliation: Norwegian University of Science and Technology
name: Aslak Steinsbekk
role: PRINCIPAL_INVESTIGATOR
affiliation: Norwegian University of Science and Technology
name: Kjersti Grønning
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.