Clinical trial NCT01035125: Effect of One Week Self-management Program in Patients With Fibromyalgia
Official title: A Study of Effect of One Week Self-management Program in Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Self-management
Self-efficacy
Coping
Health consumer
Patient education
Health related quality of life
Lead sponsor: Revmatismesykehuset AS
Sponsor class: OTHER
First posted: 2009-12-18
Enrollment: 153
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: EC-17 (Effective Musculoskeletal Consumer Scale)
timeFrame: Baseline, 3 weeks before the program, 3 weeks and 6 months after the program
measure: GHQ20 (General Health Questionnaire)
timeFrame: Baseline, 3 weeks before the program, 3 weeks and 6 months after the program
Secondary outcomes:
measure: FIQ (Fibromyalgia Impact Questionnaire)
timeFrame: Baseline, 3 weeks before the program, 3 weeks and 6 months after the program
measure: SF-36 (Short Form Health Survey)
timeFrame: Baseline, 3 weeks before the program, 3 weeks and 6 months after the program
measure: Self-efficacy Scale
timeFrame: Baseline, 3 weeks before the program, 3 weeks and 6 months after the program
Other outcomes:
Locations:
city: Lillehammer
country: Norway
facility: Lillehammer Hospital for Rheumatic Diseases
state: Oppland
Study officials:
affiliation: Revmatismesykehuset AS, Lillehammer, Norway
name: Knut Mikkelsen, MD
role: STUDY_CHAIR
References:
citation: 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.