CClinicalTrials.gg
CompletedNCT00623922Updated Apr 8, 2015

Effect of Patient Education in Rheumatic Diseases

An interventional study of Patient education with individual nurse consultations in Polyarthritis, sponsored by Norwegian University of Science and Technology. Completed at 1 site in Norway. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-04-08.

Sponsored by Norwegian University of Science and Technology · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
141
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Polyarthritis

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Keywords

  • Patient education
  • Nurse consultation
  • Arthritis
  • Wellbeing
  • Coping
  • Health related quality of life
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 141 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Norwegian University of Science and Technology is the lead sponsor of 487 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Polyarthritis
  • 18-80 years
  • native Norwegian speaking
  • able to understand and participate in the PE program

Exclusion criteria

Exclusion Criteria:

  • Participated in a patient educational program the latest 12 months
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
141 participants (actual)

Study arms

  • Experimental
    1

    Patient education

    Behavioral: Patient education with individual nurse consultations

  • No intervention
    2

    Usual care

Interventions

  • BehavioralPatient education with individual nurse consultations

    3 group meetings followed by 1-2 individual nurse consultations.

06

What researchers measure

Primary outcomes

  1. Self efficacy

    Time frame: Baseline, 4 and 12 months

  2. Well being (Arizona Integrative Outcomes Scale)

    Time frame: Baseline, 4 and 12 months

Secondary outcomes

  1. Arthritis Impact Measurement Scale 2 (affect, symptoms, social interaction, role)

    Time frame: Baseline, 4 and 12 months

  2. The Hospital Anxiety and Depression Scale

    Time frame: Baseline, 4 and 12 months

  3. Educational Needs Assessment Tools

    Time frame: Baseline, 4 and 12 months

  4. Modified Health Assessment Questionnaire

    Time frame: Baseline, 4 and 12 months

  5. DAS 28 score (Disease activity score)

    Time frame: Baseline, 4 and 12 months

  6. Patient Activation Measurement (PAM)

    Time frame: Baseline, 4 and 12 months

  7. Cost- benefit

    Time frame: Baseline, 4 and 12 months

  8. Physical activity

    Time frame: Baseline, 4 and 12 months

  9. Use of medications

    Time frame: Baseline, 4 and 12 months

  10. fatigue (VAS scale)

    Time frame: Baseline, 4 and 12 months

  11. Pain (VAS scale)

    Time frame: Baseline, 4 and 12 months

07

Study locations

1 site
  • Norwegian University of Science and Technology and St. Olavs Hospital HF
    Trondheim, 7489, Norway
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References and documents

Publications

  • 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. PubMed 15593105 ↗
  • 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. PubMed 22277625 ↗
  • 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. PubMed 23875718 ↗
  • 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. PubMed 27147905 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00623922
Lead sponsor
Norwegian University of Science and Technology
Collaborators
The Research Council of Norway
Responsible party
Sponsor
First posted
Feb 26, 2008
Start date
Feb 2008
Primary completion
Mar 2010
Completion
Mar 2010
Last update
Apr 8, 2015

Study contacts

Aslak Steinsbekk
principal investigator · Norwegian University of Science and Technology
Kjersti Grønning
principal investigator · Norwegian University of Science and Technology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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