Effect of Patient Education in Rheumatic Diseases

April 7, 2015 updated by: Norwegian University of Science and Technology

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

141

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 2
Usual care
Experimental: 1
Patient education
Behavioral: Patient education with individual nurse consultations
3 group meetings followed by 1-2 individual nurse consultations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Self efficacy
Time Frame: Baseline, 4 and 12 months
Baseline, 4 and 12 months
Well being (Arizona Integrative Outcomes Scale)
Time Frame: Baseline, 4 and 12 months
Baseline, 4 and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Arthritis Impact Measurement Scale 2 (affect, symptoms, social interaction, role)
Time Frame: Baseline, 4 and 12 months
Baseline, 4 and 12 months
The Hospital Anxiety and Depression Scale
Time Frame: Baseline, 4 and 12 months
Baseline, 4 and 12 months
Educational Needs Assessment Tools
Time Frame: Baseline, 4 and 12 months
Baseline, 4 and 12 months
Modified Health Assessment Questionnaire
Time Frame: Baseline, 4 and 12 months
Baseline, 4 and 12 months
DAS 28 score (Disease activity score)
Time Frame: Baseline, 4 and 12 months
Baseline, 4 and 12 months
Patient Activation Measurement (PAM)
Time Frame: Baseline, 4 and 12 months
Baseline, 4 and 12 months
Cost- benefit
Time Frame: Baseline, 4 and 12 months
Baseline, 4 and 12 months
Physical activity
Time Frame: Baseline, 4 and 12 months
Baseline, 4 and 12 months
Use of medications
Time Frame: Baseline, 4 and 12 months
Baseline, 4 and 12 months
fatigue (VAS scale)
Time Frame: Baseline, 4 and 12 months
Baseline, 4 and 12 months
Pain (VAS scale)
Time Frame: Baseline, 4 and 12 months
Baseline, 4 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

February 12, 2008

First Submitted That Met QC Criteria

February 24, 2008

First Posted (Estimate)

February 26, 2008

Study Record Updates

Last Update Posted (Estimate)

April 8, 2015

Last Update Submitted That Met QC Criteria

April 7, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4.2007.2472
  • NSD 17975

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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