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Randomized Controlled Trial
. 2016 Feb 3:17:55.
doi: 10.1186/s12891-016-0903-4.

Evaluation of a self-management patient education program for patients with fibromyalgia syndrome: study protocol of a cluster randomized controlled trial

Gunda Musekamp  1 , Christian Gerlich  2 , Inge Ehlebracht-König  3 , Hermann Faller  4 , Andrea Reusch  5
Affiliations
Randomized Controlled Trial

Evaluation of a self-management patient education program for patients with fibromyalgia syndrome: study protocol of a cluster randomized controlled trial

Gunda Musekamp et al. BMC Musculoskelet Disord. .

Abstract

Background: Fibromyalgia syndrome (FMS) is a complex chronic condition that makes high demands on patients' self-management skills. Thus, patient education is considered an important component of multimodal therapy, although evidence regarding its effectiveness is scarce. The main objective of this study is to assess the effectiveness of an advanced self-management patient education program for patients with FMS as compared to usual care in the context of inpatient rehabilitation.

Methods/design: We conducted a multicenter cluster randomized controlled trial in 3 rehabilitation clinics. Clusters are groups of patients with FMS consecutively recruited within one week after admission. Patients of the intervention group receive the advanced multidisciplinary self-management patient education program (considering new knowledge on FMS, with a focus on transfer into everyday life), whereas patients in the control group receive standard patient education programs including information on FMS and coping with pain. A total of 566 patients are assessed at admission, at discharge and after 6 and 12 months, using patient reported questionnaires. Primary outcomes are patients' disease- and treatment-specific knowledge at discharge and self-management skills after 6 months. Secondary outcomes include satisfaction, attitudes and coping competences, health-promoting behavior, psychological distress, health impairment and participation. Treatment effects between groups are evaluated using multilevel regression analysis adjusting for baseline values.

Discussion: The study evaluates the effectiveness of a self-management patient education program for patients with FMS in the context of inpatient rehabilitation in a cluster randomized trial. Study results will show whether self-management patient education is beneficial for this group of patients.

Trial registration: German Clinical Trials Register, DRKS00008782 , Registered 8 July 2015.

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Study protocol diagram of data collection process
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References

    1. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001;357:1191–4. doi: 10.1016/S0140-6736(00)04337-3. - DOI - PubMed
    1. Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200–7. doi: 10.7326/0003-4819-158-3-201302050-00583. - DOI - PMC - PubMed
    1. Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, et al. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res. 2010;62:600–10. doi: 10.1002/acr.20140. - DOI - PubMed
    1. Branco JC, Bannwarth B, Failde I, Abello Carbonell J, Blotman F, Spaeth M, et al. Prevalence of fibromyalgia: a survey in five European countries. Semin Arthritis Rheum. 2010;39:448–53. doi: 10.1016/j.semarthrit.2008.12.003. - DOI - PubMed
    1. Bennett RM, Jones J, Turk DC, Russell IJ, Matallana L. An internet survey of 2,596 people with fibromyalgia. BMC Musculoskelet Disord. 2007;8:27. doi: 10.1186/1471-2474-8-27. - DOI - PMC - PubMed

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