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

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00008782
• Date of registration: 08/07/2015
• Prospective Registration: No
• Primary sponsor: Abteilung für Medizinische Psychologie und Psychotherapie, Medizinische Soziologie und Rehabilitationswissenschaften
• Public title: Evaluation of a self-management patient education program for patients with fibromyalgia syndrome.
• Scientific title: Evaluation of a self-management patient education program for patients with fibromyalgia syndrome. - FimS
• Date of first enrolment: 06/10/2014
• Target sample size: 566
• Recruitment status: Complete
• URL: http://drks.de/search/en/trial/DRKS00008782
• Study type: interventional
• Study design: Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: active; Assignment: other; Study design purpose: treatment
• Phase: N/A

Countries of recruitment

Germany

Contacts

• Name: Andrea Reusch
• Affiliation: Abteilung für Medizinische Psychologie und Psychotherapie, Medizinische Soziologie und Rehabilitationswissenschaften

• Name: Andrea Reusch
• Affiliation: Abteilung für Medizinische Psychologie und Psychotherapie, Medizinische Soziologie und Rehabilitationswissenschaften

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

M79.7

Fibromyalgia

M79.7

Intervention(s)

Group 1: 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.
Group 2: 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, fibromyalg

Primary Outcome(s)

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

Secondary Outcome(s)

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)

Source(s) of Monetary Support

Deutsche Rentenversicherung Bund

Ethics review

Status: Approved
Approval date: 22/04/2014
Contact:

[e-mail]

Ethik-Kommission der Universität Würzburg, Institut für Pharmakologie und Toxikologie

[phone]

[e-mail]

Results

• Date Completed: 14/01/2017
• URL: http://drks.de/search/en/trial/DRKS00008782#studyResults