Trial document





This trial has been registered retrospectively.
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  DRKS00008782

Trial Description

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Title

Evaluation of a self-management patient education program for patients with fibromyalgia syndrome.

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Trial Acronym

FimS

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URL of the Trial

http://www.psychotherapie.uni-wuerzburg.de/forschung/projekte-koop_26.html

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Brief Summary in Lay Language

The fibromyalgia syndrome is a complex chronic condition. Treatment includes self-management patient education, among others. An advanced self-management program for patients with fibromyalgia syndrome (Dr. Ehlebracht-König, Bad Eilsen) aims at communicating a multidisciplinary understanding of the disease and helping to self-manage the disease. It contains 6 sessions of 90 minutes each, is delivered in inpatient rehabilitation and was valued positively by patients. This study aims to test the effectiveness of the program in inpatient rehabilitation as compared to usual care (education). We investigate whether the program is superior to usual care (education) in short-, intermediate- and long-term regarding disease- and treatment-specific knowledge, self-management competencies and other outcomes (satisfaction, health-promoting behavior, psychological distress, health impairment, and participation). Participants are 566 rehabilitants with fibromyalgia syndrome in three rehabilitation clinics. Half of the patients receive the advanced self-management program and the other half the usual education. Allocation of participants to both treatments is randomized. Data of patients are collected with questionnaires at begin and end of rehabilitation and after 6 and 12 months.

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Brief Summary in Scientific Language

Study objective is the evaluation of an advanced self-management patient education program for patients with fibromyalgia syndrome (Ehlebracht-König, Siemienik, Dorn & Reusch, submitted) in inpatient rehabilitation. Aim of the program is the promotion of a biopsychosocial understanding and self-management of the disease. It contains 6 session of 90 minutes each and was positively evaluated by participants in a formative evaluation. Our main research question is the short-, intermediate- and long-term effectiveness of the self-management program compared to usual care (education). The study is a multicenter, cluster-randomized, controlled trial. Adult rehabilitants with diagnosis of fibromyalgia syndrome (n = 566) from three rehabilitation clinics are consecutively included in the study. Clusters of participants are randomly allocated to the two study arms. Data are assessed at admission, discharge and after 6 and 12 month with patient-reported questionnaires. The primary outcome is disease- and treatment specific knowledge and self-management competence. Secondary outcomes include satisfaction, pain-related control beliefs, health-promoting behavior, psychological distress, health impairment, and participation. Hypotheses will be tested using multilevel regression analysis adjusting for baseline values.

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Organizational Data

  •   DRKS00008782
  •   2015/07/08
  •   [---]*
  •   yes
  •   Approved
  •   46/14, Ethik-Kommission der Medizinischen Fakultät der Universität Würzburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   M79.7 -  Fibromyalgia
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Interventions/Observational Groups

  •   Intervention condition is an advanced self-management patient education program for patients with fibromyalgia syndrome. This consists of 6 sessions of 90 minutes each and one optional preparing session. It should be delivered in small groups of 12 participants maximum. The program is manualized and led by physicians, psychologists and physiotherapists. Methods are interactive, with patients actively involved and different didactic methods used (interactive short lectures, group discussion, practice, individual work). Materials include presentations, flipchart, work sheets and patient information sheets. Contents of the sessions include fibromyalgia-related information (e.g. symptoms, diagnosis, course, causes and influencing factors, frequency), information about treatment (e.g. treatment options, medication, physical therapy, psychotherapy, risks and benefits of other therapies), coping with pain and stress as well as promotion of sustained physical activity. There is a focus on both self-management and transfer into everyday life through action planning.
  •   Control condition is the treatment as usual (education) of the respective clinic. In one cooperating clinic, this is the previously practiced, interactive patient education for fibromyalgia syndrome with 5 sessions (90 minutes each; content: illness and treatment information, coping with pain and stress, exercise therapy). In the second cooperating clinic, patients participate in a coping with pain group with 4 sessions (90 minutes each; content: information about pain, coping with pain, transfer into daily life) and receive a flyer about the fibromyalgia syndrome. In the third cooperating clinic, patients are informed by physician-delivered lectures (60 minutes each) about chronic pain, fibromyalgia syndrome and stress and may participate in group programs for pain or stress coping (each with 4 sessions of 45 minutes each) or autogenic training, as indicated.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control (effective treament of control group)
  •   Treatment
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

1) Disease- and treatment specific knowledge at discharge (also measured after 12 months): self-developed instrument
2) Self-management competence after 6 month (also measured at discharge, after 12 months): Health Education Impact Questionnaire (heiQ; Osborne et al., 2007, Schuler et al., 2013), subscales: skill and technique acquisition, self-monitoring and insight

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Secondary Outcome

1) Attitudes and Coping competences (discharge, after 6 months, after 12 months): 1.1) pain-related controllability: German version of the Rheumatology Attitudes Index (Leibing, Hoyer, Romatzki & Ehlers, 1999); 1.2) Acceptance of the disease and communication: self-developed instrument
2) Behavior determinants for physical activity and relaxation (discharge): Intention, action- and coping planning (self-developed instrument)
3) Behavior (after 6 months, after 12 months): 3.1) health-promoting behavior, active lifestyle: physical activity (Godin & Shephard, 1985); relaxation (self-developed according to Ströbl et al.); Health Education Impact Questionnaire (heiQ; Osborne et al., 2007, Schuler et al., 2013), subscale active engagement in life, health-promoting activities; 3.2) Interaction in the health system: Health Education Impact Questionnaire (heiQ; Osborne et al., 2007, Schuler et al., 2013), subscale health services navigation
4) Health Impairment (discharge, after 6 months, after 12 months): Fibromyalgia Impact Questionnaire without the physical functioning subscale (FIQ-G; Burckhardt et al., 1991, Offenbächer et al., 2000)
5) Depressive symptoms and anxiety (discharge, after 6 months, after 12 months): Short form of the Patient Health Questionnaire (PHQ-4; Löwe et al., 2010)
6) Participation (after 6 months, after 12 months): Fibromyalgia Participation Questionnaire (FPQ; Farin et al., 2013)
7) Socio-medical and health-economic parameters (discharge, after 6 months, after 12 months): sick leave days (not at discharge), subjective predicton of ability to work (SPE-Scale, Mittag & Raspe, 2003), treatment since rehabilitation (not at discharge)
8) Treatment satisfaction (discharge): Questionnaire of treatment satisfaction (according to Meng et al., 2009)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2014/10/06
  •   566
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

patients in inpatient rehabilitation clinics with main diagnosis fibromyalgia syndrome (ICD-10: M79.7)

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Exclusion Criteria

insufficient German language ability, severe psychiatric comorbidity which leads to inability to participate in a group, cognitive impairment, not corrected severe visual or hearing impairment

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Addresses

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    • Abteilung für Medizinische Psychologie und Psychotherapie, Medizinische Soziologie und Rehabilitationswissenschaften
    • Mr.  Prof. Dr. Dr.  Hermann  Faller 
    • Klinikstraße 3
    • 97070  Würzburg
    • Germany
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    • Abteilung für Medizinische Psychologie und Psychotherapie, Medizinische Soziologie und Rehabilitationswissenschaften
    • Ms.  Andrea  Reusch 
    • Klinikstraße 3
    • 97070  Würzburg
    • Germany
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    • Abteilung für Medizinische Psychologie und Psychotherapie, Medizinische Soziologie und Rehabilitationswissenschaften
    • Ms.  Andrea   Reusch 
    • Klinikstraße 3
    • 97070  Würzburg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Rentenversicherung Bund
    • Hohenzollerndamm 45
    • 10713  Berlin
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2017/01/14
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Trial Publications, Results and other Documents

  •   Musekamp, G., Gerlich, C., Ehlebracht-König, I., Faller, H. & Reusch, A. (2016). Evaluation of a self-management patient education program for patients with fibromyalgia syndrome: study protocol of a cluster randomized controlled trial. BMC Musculoskeletal Disorders, 17, 55. DOI: 10.1186/s12891-016-0903-4.
  •   Musekamp, G., Gerlich, C., Ehlebracht-König, I., Dorn, M., Höfter, A., Tomiak, C., Schlittenhardt, D., Faller, H. & Reusch, A. (2019). Evaluation of a self-management patient education program for fibromyalgia - Results of a cluster-RCT in inpatient rehabilitation. Health Education Research.DOI: 10.1093/her/cyy055
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* This entry means the parameter is not applicable or has not been set.