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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01035125
First Posted: December 18, 2009
Last Update Posted: July 28, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Revmatismesykehuset AS
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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 ]
  • GHQ20 (General Health Questionnaire) [ Time Frame: Baseline, 3 weeks before the program, 3 weeks and 6 months after the program ]

Secondary Outcome Measures:
  • FIQ (Fibromyalgia Impact Questionnaire) [ Time Frame: 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 ]
  • Self-efficacy Scale [ Time Frame: Baseline, 3 weeks before the program, 3 weeks and 6 months after the program ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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

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
First Submitted: December 17, 2009
First Posted: December 18, 2009
Last Update Posted: July 28, 2011
Last Verified: July 2011

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