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

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01035125
• Other study ID #: REK 39-07138b 1.2007.1416
• Status: Completed
• Phase: N/A
• First received: December 17, 2009
• Last updated: July 27, 2011
• Start date: December 2008
• Est. completion date: July 2011

Study information

• Verified date: July 2011
• Source: Revmatismesykehuset AS
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Data Protection Authority
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: July 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Behavioral:
• Self-management program
Participants will receive a one week inpatient self-management program

Locations

Country	Name	City	State
Norway	Lillehammer Hospital for Rheumatic Diseases	Lillehammer	Oppland

Sponsors (1)

Lead Sponsor	Collaborator
Revmatismesykehuset AS

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EC-17 (Effective Musculoskeletal Consumer Scale)		Baseline, 3 weeks before the program, 3 weeks and 6 months after the program	No
Primary	GHQ20 (General Health Questionnaire)		Baseline, 3 weeks before the program, 3 weeks and 6 months after the program	No
Secondary	FIQ (Fibromyalgia Impact Questionnaire)		Baseline, 3 weeks before the program, 3 weeks and 6 months after the program	No
Secondary	SF-36 (Short Form Health Survey)		Baseline, 3 weeks before the program, 3 weeks and 6 months after the program	No
Secondary	Self-efficacy Scale		Baseline, 3 weeks before the program, 3 weeks and 6 months after the program	No