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

Abstract

BackgroundFibromyalgia 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/DesignWe 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.DiscussionThe 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 registrationGerman Clinical Trials Register, DRKS00008782, Registered 8 July 2015

Management of fibromyalgia syndrome

“…A brief summary is provided in Figure 1. 4,5,10,12,[23][24][25][26][27][28][29][30][31][32][33] The examples provided in the figure have been shown to be effective in treating FMS and often incorporate multiple CBT strategies. Since there is no standardized definition of what constitutes a formal CBT treatment 17 , we have categorized each of the examples according to the definition outlined by Beck.…”

Stellenwert der Patientenschulung für Patientinnen und Patienten mit Fibromyalgie-Syndrom

“…Die Ergebnisse fanden Eingang in eine vollständige Überarbeitung des Patientenschulungsmanuals für Fibromyalgie-Betroffene. Letzteres ist auf der Internetseite des Zentrum Patientenschulung verfügbar (http://zentrum-patientenschulung.de) und wird zwischenzeitlich im Rahmen einer multizentrischen Studie evaluiert (27).…”

“…Die Ergebnisse der Befragung fanden Eingang in die Überarbeitung des Patientenschulungsprogramms für Patienten mit Fibromyalgie-Syndrom (11). Das Schulungsprogramm wird aktuell im Rahmen einer multizentrischen Studie evaluiert (27). Bei dieser Evaluation werden sowohl schulungsnahe als auch schulungsferne Effekte untersucht (34).…”

The Impact of a Peer Social Support Network From the Perspective of Women With Fibromyalgia. A Qualitative Study

“…Management of chronic diseases like FM requires a high level of commitment from patients, so their empowerment represents an important milestone in treatment [15]. According to Nijs et al [16], people with diffuse chronic musculoskeletal pain and poor control over FM show less tolerance and have more catastrophic thinking processes and weaker coping strategies.…”