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
  Purpose

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.


Condition Intervention
Polyarthritis
Behavioral: Patient education with individual nurse consultations

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: The Effect of Patient Education on Coping and Well Being in Patients With Arthritis.

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 141
Study Start Date: February 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patient education
Behavioral: Patient education with individual nurse consultations
3 group meetings followed by 1-2 individual nurse consultations.
No Intervention: 2
Usual care

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623922

Locations
Norway
Norwegian University of Science and Technology and St. Olavs Hospital HF
Trondheim, Norway, 7489
Sponsors and Collaborators
Norwegian University of Science and Technology
The Research Council of Norway
Investigators
Principal Investigator: Aslak Steinsbekk Norwegian University of Science and Technology
Principal Investigator: Kjersti Grønning Norwegian University of Science and Technology
  More Information

Publications:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00623922     History of Changes
Other Study ID Numbers: 4.2007.2472, NSD 17975
Study First Received: February 12, 2008
Last Updated: January 27, 2012
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:
Patient education
Nurse consultation
Arthritis
Wellbeing
Coping
Health related quality of life

Additional relevant MeSH terms:
Rheumatic Diseases
Arthritis
Musculoskeletal Diseases
Connective Tissue Diseases
Joint Diseases

ClinicalTrials.gov processed this record on August 19, 2014