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

NCT ID: NCT01035125

Last Updated: 2011-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2011-07-31

Brief 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.

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Waiting list

Group Type: NO_INTERVENTION

No interventions assigned to this group

Self-management program

One week self-management program

Group Type: EXPERIMENTAL

Self-management program

Intervention Type: BEHAVIORAL

Participants will receive a one week inpatient self-management program

Interventions

Self-management program

Participants will receive a one week inpatient self-management program

Intervention Type: BEHAVIORAL

Other Intervention Names

Patient education

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Revmatismesykehuset AS

OTHER

Sponsor Role: lead

Responsible Party

Revmatismesykehuset AS

Principal Investigators

Knut Mikkelsen, MD

Role: STUDY_CHAIR

Revmatismesykehuset AS, Lillehammer, Norway

Locations

Lillehammer Hospital for Rheumatic Diseases

Lillehammer, Oppland, Norway

Countries

Norway

References

Hamnes B, Mowinckel P, Kjeken I, Hagen KB. Effects of a one week multidisciplinary inpatient self-management programme for patients with fibromyalgia: a randomised controlled trial. BMC Musculoskelet Disord. 2012 Sep 26;13:189. doi: 10.1186/1471-2474-13-189.

Reference Type: DERIVED

PMID: 23013162 (View on PubMed)

Other Identifiers

REK 39-07138b 1.2007.1416

Identifier Type: -

Identifier Source: org_study_id