NCT01035125

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

July 28, 2011

Status Verified

July 1, 2011

Enrollment Period

2.2 years

First QC Date

December 17, 2009

Last Update Submit

July 27, 2011

Conditions

Fibromyalgia

Keywords

Self-managementSelf-efficacyCopingHealth consumerPatient educationHealth related quality of life

Outcome Measures

Primary Outcomes (2)

  • EC-17 (Effective Musculoskeletal Consumer Scale)

    Baseline, 3 weeks before the program, 3 weeks and 6 months after the program

  • GHQ20 (General Health Questionnaire)

    Baseline, 3 weeks before the program, 3 weeks and 6 months after the program

Secondary Outcomes (3)

  • FIQ (Fibromyalgia Impact Questionnaire)

    Baseline, 3 weeks before the program, 3 weeks and 6 months after the program

  • SF-36 (Short Form Health Survey)

    Baseline, 3 weeks before the program, 3 weeks and 6 months after the program

  • Self-efficacy Scale

    Baseline, 3 weeks before the program, 3 weeks and 6 months after the program

Study Arms (2)

Waiting list

NO INTERVENTION

Self-management program

EXPERIMENTAL

One week self-management program

Behavioral: Self-management program

Interventions

Self-management programBEHAVIORAL

Participants will receive a one week inpatient self-management program

Also known as: Patient education
Self-management program

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lillehammer Hospital for Rheumatic Diseases

Lillehammer, Oppland, 2609, Norway

Location

Related Publications (1)

  • 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.

    PMID: 23013162DERIVED

MeSH Terms

Conditions

Fibromyalgia

Interventions

Self-ManagementPatient Education as Topic

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

RehabilitationHealth ServicesHealth Care Facilities Workforce and ServicesHealth EducationPreventive Health Services

Study Officials

  • Knut Mikkelsen, MD

    Revmatismesykehuset AS, Lillehammer, Norway

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 17, 2009

First Posted

December 18, 2009

Study Start

December 1, 2008

Primary Completion

February 1, 2011

Study Completion

July 1, 2011

Last Updated

July 28, 2011

Record last verified: 2011-07

Locations

NO(1)