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Effect of Patient Education in Rheumatic Diseases

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ClinicalTrials.gov Identifier: NCT00623922
Recruitment Status : Completed
First Posted : February 26, 2008
Last Update Posted : April 8, 2015
Sponsor:
Collaborator:
The Research Council of Norway
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Study Description
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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.


Condition or disease Intervention/treatment Phase
Polyarthritis Behavioral: Patient education with individual nurse consultations Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The Effect of Patient Education on Coping and Well Being in Patients With Arthritis.
Study Start Date : February 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00623922


Locations
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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
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Principal Investigator: Aslak Steinsbekk Norwegian University of Science and Technology
Principal Investigator: Kjersti Grønning Norwegian University of Science and Technology
More Information
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Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00623922    
Other Study ID Numbers: 4.2007.2472
NSD 17975
First Posted: February 26, 2008    Key Record Dates
Last Update Posted: April 8, 2015
Last Verified: April 2015
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:
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Arthritis
Joint Diseases
Musculoskeletal Diseases