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Effect of Patient Education in Rheumatic Diseases

This study has been completed.
Sponsor:
Collaborator:
The Research Council of Norway
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00623922
First received: February 12, 2008
Last updated: January 27, 2012
Last verified: January 2012
History of Changes

February 12, 2008
January 27, 2012
February 2008
March 2010   (final data collection date for primary outcome measure)
  • Self efficacy [ Time Frame: Baseline, 4 and 12 months ] [ Designated as safety issue: No ]
  • Well being (Arizona Integrative Outcomes Scale) [ Time Frame: Baseline, 4 and 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00623922 on ClinicalTrials.gov Archive Site
  • Arthritis Impact Measurement Scale 2 (affect, symptoms, social interaction, role) [ Time Frame: Baseline, 4 and 12 months ] [ Designated as safety issue: No ]
  • The Hospital Anxiety and Depression Scale [ Time Frame: Baseline, 4 and 12 months ] [ Designated as safety issue: No ]
  • Educational Needs Assessment Tools [ Time Frame: Baseline, 4 and 12 months ] [ Designated as safety issue: No ]
  • Modified Health Assessment Questionnaire [ Time Frame: Baseline, 4 and 12 months ] [ Designated as safety issue: No ]
  • DAS 28 score (Disease activity score) [ Time Frame: Baseline, 4 and 12 months ] [ Designated as safety issue: No ]
  • Patient Activation Measurement (PAM) [ Time Frame: Baseline, 4 and 12 months ] [ Designated as safety issue: No ]
  • Cost- benefit [ Time Frame: Baseline, 4 and 12 months ] [ Designated as safety issue: No ]
  • Physical activity [ Time Frame: Baseline, 4 and 12 months ] [ Designated as safety issue: No ]
  • Use of medications [ Time Frame: Baseline, 4 and 12 months ] [ Designated as safety issue: No ]
  • fatigue (VAS scale) [ Time Frame: Baseline, 4 and 12 months ] [ Designated as safety issue: No ]
  • Pain (VAS scale) [ Time Frame: Baseline, 4 and 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Polyarthritis
Behavioral: Patient education with individual nurse consultations
3 group meetings followed by 1-2 individual nurse consultations.
  • Experimental: 1
    Patient education
    Intervention: Behavioral: Patient education with individual nurse consultations
  • No Intervention: 2
    Usual care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
141
March 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00623922
4.2007.2472, NSD 17975
No
Norwegian University of Science and Technology
Norwegian University of Science and Technology
The Research Council of Norway
Principal Investigator: Aslak Steinsbekk Norwegian University of Science and Technology
Principal Investigator: Kjersti Grønning Norwegian University of Science and Technology
Norwegian University of Science and Technology
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP