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

This study has been completed.
Sponsor:
Information provided by:
Revmatismesykehuset AS
ClinicalTrials.gov Identifier:
NCT01035125
First received: December 17, 2009
Last updated: July 27, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention
Fibromyalgia
 Behavioral: Self-management program

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

Resource links provided by NLM:

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Further study details as provided by Revmatismesykehuset AS:

Primary Outcome Measures:
  • EC-17 (Effective Musculoskeletal Consumer Scale) [ Time Frame: Baseline, 3 weeks before the program, 3 weeks and 6 months after the program ] [ Designated as safety issue: No ]
  • GHQ20 (General Health Questionnaire) [ Time Frame: Baseline, 3 weeks before the program, 3 weeks and 6 months after the program ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FIQ (Fibromyalgia Impact Questionnaire) [ Time Frame: Baseline, 3 weeks before the program, 3 weeks and 6 months after the program ] [ Designated as safety issue: No ]
  • SF-36 (Short Form Health Survey) [ Time Frame: Baseline, 3 weeks before the program, 3 weeks and 6 months after the program ] [ Designated as safety issue: No ]
  • Self-efficacy Scale [ Time Frame: Baseline, 3 weeks before the program, 3 weeks and 6 months after the program ] [ Designated as safety issue: No ]

Enrollment: 153
Study Start Date: December 2008
Study Completion Date: July 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Patient education

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01035125

Locations
Norway
Lillehammer Hospital for Rheumatic Diseases
Lillehammer, Oppland, Norway, 2609
Sponsors and Collaborators
Revmatismesykehuset AS
Investigators
Study Chair: Knut Mikkelsen, MD Revmatismesykehuset AS, Lillehammer, Norway
  More Information

No publications provided by Revmatismesykehuset AS

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

Responsible Party: Study chair: Knut Mikkelsen, Revmatismesykehuset AS
ClinicalTrials.gov Identifier: NCT01035125     History of Changes
Other Study ID Numbers: REK 39-07138b 1.2007.1416
Study First Received: December 17, 2009
Last Updated: July 27, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Data Protection Authority

Keywords provided by Revmatismesykehuset AS:
Self-management
Self-efficacy
Coping
 Health consumer
Patient education
Health related quality of life

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on June 17, 2013