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

Primary Purpose

Fibromyalgia

Status

Completed

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

Self-management program

About this trial

This is an interventional health services research trial for Fibromyalgia focused on measuring Self-management, Self-efficacy, Coping, Health consumer, Patient education, Health related quality of life

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Lillehammer Hospital for Rheumatic Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Waiting list

Self-management program

Arm Description

One week self-management program

Outcomes

Primary Outcome Measures

EC-17 (Effective Musculoskeletal Consumer Scale)

GHQ20 (General Health Questionnaire)

Secondary Outcome Measures

FIQ (Fibromyalgia Impact Questionnaire)

SF-36 (Short Form Health Survey)

Self-efficacy Scale

Full Information

NCT ID

NCT01035125

First Posted

December 17, 2009

Last Updated

July 27, 2011

Sponsor

Revmatismesykehuset AS

1. Study Identification

Unique Protocol Identification Number

NCT01035125

Brief Title

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

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

February 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Revmatismesykehuset AS

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia

Keywords

Self-management, Self-efficacy, Coping, Health consumer, Patient education, Health related quality of life

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

153 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Waiting list

Arm Type

No Intervention

Arm Title

Self-management program

Arm Type

Experimental

Arm Description

One week self-management program

Intervention Type

Behavioral

Intervention Name(s)

Self-management program

Other Intervention Name(s)

Patient education

Intervention Description

Participants will receive a one week inpatient self-management program

Primary Outcome Measure Information:

Title

EC-17 (Effective Musculoskeletal Consumer Scale)

Time Frame