title: Evaluation of a self-management patient education program for patients with fibromyalgia syndrome: study protocol of a cluster randomized controlled trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  German Clinical Trials Register, DRKS00008782 , Registered 8 July 2015.
authors: Department of Medical Psychology and Psychotherapy, Medical Sociology and Rehabilitation Sciences, University of Würzburg, Klinikstr. 3, D-97070, Würzburg, Germany. gunda.musekamp@uni-wuerzburg.de.
authors: Gunda
authors: G
authors: Musekamp
authors: Department of Medical Psychology and Psychotherapy, Medical Sociology and Rehabilitation Sciences, University of Würzburg, Klinikstr. 3, D-97070, Würzburg, Germany. christian.gerlich@uni-wuerzburg.de.
authors: Christian
authors: C
authors: Gerlich
authors: Rehabilitation Center Bad Eilsen, Brunnenpromenade 2, D-31707, Bad Eilsen, Germany. inge.ehlebracht-koenig@rehazentrum-bad-eilsen.de.
authors: Inge
authors: I
authors: Ehlebracht-König
authors: Department of Medical Psychology and Psychotherapy, Medical Sociology and Rehabilitation Sciences, University of Würzburg, Klinikstr. 3, D-97070, Würzburg, Germany. h.faller@uni-wuerzburg.de.
authors: Hermann
authors: H
authors: Faller
authors: Department of Medical Psychology and Psychotherapy, Medical Sociology and Rehabilitation Sciences, University of Würzburg, Klinikstr. 3, D-97070, Würzburg, Germany. a.reusch@uni-wuerzburg.de.
authors: Andrea
authors: A
authors: Reusch
mesh_terms: D000203:Activities of Daily Living; D000223:Adaptation, Psychological; D002985:Clinical Protocols; D005356:Fibromyalgia / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D005858:Germany; D015438:Health Behavior; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D010353:Patient Education as Topic; D017060:Patient Satisfaction; D015397:Program Evaluation; D012107:Research Design; D012648:Self Care / Q000379:methods*; D011795:Surveys and Questionnaires; D013577:Syndrome; D013997:Time Factors; D016896:Treatment Outcome