Effect of One Week Self-management Program in Patients With Fibromyalgia

July 27, 2011 updated by: Revmatismesykehuset AS

A Study of Effect of One Week Self-management Program in Patients With Fibromyalgia

The purpose of this study is to explore the effect of one week inpatient self-management program (SMP) in patients with fibromyalgia. The SMP is delivered as group education/activities by allied health professionals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will determine if one week inpatient SMP can reduce FM symptoms and increase patients self-efficacy, health status, quality of life and being active health consumers.

The one-week SMP is designed to help people manage their rheumatic disease and challenges in daily life. The program has the same core concepts as outpatient programmes and comprises information, discussions on how to cope with the disease and daily life, cognitive management skills, exercise, engagement in self-care and interactions with healthcare professionals. During the program, the inpatient education unit takes up to 16 patients and 5 relatives per week within one diagnostic group. Each educational session lasts for 1.5-2.5 hours and the physical activity sessions for 0.5-1 hour. In the evening group sessions, the patients are divided into small groups of approximately five participants. They talk together for one hour under leadership of one health professional who is educated in coaching. The focus is on coping with the disease and daily life.

For the intervention group there will be a one year follow up study.

Study Type

Interventional

Enrollment (Actual)

153

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
    • Oppland
      • Lillehammer, Oppland, Norway, 2609
        • Lillehammer Hospital for Rheumatic Diseases

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

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of Fibromyalgia outlined by the American College of Rheumatology for one year or more
  • Between 20 and 70 years old
  • Native Norwegian speaking
  • Own wishes about participating the self-management program

Exclusion Criteria:

  • Participated in the hospitals' SMP before
  • Cognitive dysfunction
  • Problems with sight and hearing that not can be compensated
  • Mental disorders except light or treated depressions

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: Waiting list
Experimental: Self-management program
One week self-management program
Behavioral: Self-management program
Participants will receive a one week inpatient self-management program
Other Names:
  • Patient education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
EC-17 (Effective Musculoskeletal Consumer Scale)
Time Frame: Baseline, 3 weeks before the program, 3 weeks and 6 months after the program
Baseline, 3 weeks before the program, 3 weeks and 6 months after the program
GHQ20 (General Health Questionnaire)
Time Frame: Baseline, 3 weeks before the program, 3 weeks and 6 months after the program
Baseline, 3 weeks before the program, 3 weeks and 6 months after the program

Secondary Outcome Measures

Outcome Measure
Time Frame
FIQ (Fibromyalgia Impact Questionnaire)
Time Frame: Baseline, 3 weeks before the program, 3 weeks and 6 months after the program
Baseline, 3 weeks before the program, 3 weeks and 6 months after the program
SF-36 (Short Form Health Survey)
Time Frame: Baseline, 3 weeks before the program, 3 weeks and 6 months after the program
Baseline, 3 weeks before the program, 3 weeks and 6 months after the program
Self-efficacy Scale
Time Frame: Baseline, 3 weeks before the program, 3 weeks and 6 months after the program
Baseline, 3 weeks before the program, 3 weeks and 6 months after the program

Collaborators and Investigators

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

Sponsor

Revmatismesykehuset AS

Investigators

  • Study Chair: Knut Mikkelsen, MD, Revmatismesykehuset AS, Lillehammer, Norway

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

December 1, 2008

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

December 17, 2009

First Submitted That Met QC Criteria

December 17, 2009

First Posted (Estimate)

December 18, 2009

Study Record Updates

Last Update Posted (Estimate)

July 28, 2011

Last Update Submitted That Met QC Criteria

July 27, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REK 39-07138b 1.2007.1416

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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