Trial document



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  DRKS00009780

Trial Description

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Title

Evaluation of WMR of the Federal German Pension Insurance in patients with musculoskeletal disorders

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Trial Acronym

EVA-WMR

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URL of the Trial

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Brief Summary in Lay Language

Work-related medical rehabilitation (WMR) is a strategy of the German Pension Insurance, especially developed for patients with severe restrictions of their work ability (e.g. long-term sick leave and poor return to work [RTW] prognosis). WMR aims to improve work ability and to support RTW in these patients by a strong focus on work demands and work capacities. Studies that tested the efficacy of WMR under ideal study conditions have shown effects on various outcomes (e.g. sick leave or pain). However, an evaluation of its effectiveness (i.e. effects under conditions of daily routine) is still missing.
The study therefore analyses the effects of WMR under conditions of daily routine.
Amendment 1 (28/06/2016): Typographic corrections. A secondary outcome was added (medication use). Another secondary outcome was removed as it was erroneously added in the first version.
Amendment 2 (21/06/2019): Typographic corrections. We added that the analyses of the primary outcomes were done without Bonferroni adjustment. The final sample size of the matched analyses was added.

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Brief Summary in Scientific Language

In Germany, rehabilitation programs with a strong work-related focus in diagnostics and therapy were established during the last years – especially for patients with musculoskeletal disorders. These programs are named work-related medical rehabilitation (WMR). They focus on patients with severe restrictions of work ability and aim to support return to work by considering individual workplace demands and required capabilities.
There is evidence from randomized controlled trials that WMR programs are more effective in improving work-related outcomes than conventional medical rehabilitation. These studies were characterized by a high implementation accuracy and carefully specified criteria for inclusion and exclusion of patients. However, the identification of the targeted patients, their allocation to a WMR program as well as the proper implementation of diagnostic and therapeutic WMR measures are still challenging, especially in daily routine.
Beside the given evidence for the efficacy of WMR programs, there is a lack of evidence of the effect of WMR under real-life conditions (effectiveness).
The study therefore analyses the effects of WMR under conditions of daily routine. The study also examines if the patients targeted are reached and if WMR is implemented as intended. Included are patients with approved medical rehabilitation due to musculoskeletal disorders. Data are assessed by written surveys before rehabilitation and 3 and 10 months after rehabilitation. Additionally, administrative data is used which covers data on rehabilitation and employment. Furthermore, the study also comprises a written survey of all 150 rehabilitation centers (with and without a WMR department), a retrospective analysis of therapeutic measures documented by these centers before and after the implementation of WMR, a qualitative content analysis of the WMR concepts of all 82 centers with an WMR department, and a workshop with rehabilitation patients to discuss the results of the study.
Effectiveness of WMR will be tested by a propensity score matched comparison of WMR and common medical rehabilitation. Additionally, individual and institutional moderators on effectiveness will be examined.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00009780
  •   2016/02/10
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  •   no
  •   Approved
  •   15-356, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
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Secondary IDs

  •   U1111-1177-4368 
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Health Condition or Problem studied

  •   M00-M99 -  Diseases of the musculoskeletal system and connective tissue
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Interventions/Observational Groups

  •   People in study arm 1 (intervention) will receive a 3-week WMR in a rehabilitation center with a WMR department approved by the Federal German Pension Insurance. WMR contains intensified work-related diagnostics, work-place and functional capacity training, work-related psychosocial groups and intensified social counseling.
    Goals and contents as well as frequency and duration of these core-interventions are characterized in a guideline for WMR (Federal German Pension Insurance 2010, 2012). The concrete shaping of the measures is up to the rehabilitation centers.
    Consistency of the WMR concepts and conformity with the WMR guideline was examined during the approval procedure of the WMR departments by the German Federal Pension Insurance.
  •   People in study arm 2 (control condition) receive a conventional 3-week medical rehabilitation according to the guideline for musculoskeletal rehabilitation in an institution approved by the Federal German Pension Insurance.
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Primary ouctomes will be assessed 10 months after completing the rehabilitation program: 1) days of sick leave after discharge from rehabilitation, stable return to work (i.e. at least 4 weeks employed without sick leave) and the time until returning to work, and 3) subjective work ability (Work Ability Score, Tuomi 1991). These outcomes will be also assessed 3 months after completing the rehabilitation program. The analyses of the primary outcomes were done without Bonferrioni adjustment as the actual sample was smaller than planned.

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Secondary Outcome

The following secondary outcomes will be assessed by questionnaires 3 and 10 months after completing the rehabilitation program (unless otherwise stated): general health (Nübling and Hasselhorn 2006), physical functioning (Wirtz et al. 2005), depression and anxiety (Löwe and Rose 2010), pain (Klasen et al. 2004), fear of movement (Pfingsten et al. 2000; Kent et al. 2014), physical activity (Lippke and Vögele 2006), medication use (own development), self-management skills (Osborne et al. 2007), employment and current sickness absence (own development), subjective prognosis of employment status (Mittag et al. 2006), perception and evaluation of vocational orientation of the received rehabilitation (own development) (measured after 3 months only), treatment satisfaction (Schmidt 1989) (measured after 3 months only). The following outcomes will be extracted from the pension insurance accounts in 2017: duration of and income from regular employment in 2016 (administrative data) and welfare benefits in 2016 (short- and long-term unemployment benefits, sickness benefit) (administrative data).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2016/03/07
  •   1800
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

Patients with musculoskeletal disorders receiving an rehabilitation on behalf of the Federal German Pension Insurance

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Exclusion Criteria

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Addresses

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    • Deutsche Rentenversicherung Bund
    • Ruhrstraße 2
    • 10709  Berlin
    • Germany
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    • Universität zu Lübeck, Institut für Sozialmedizin und Epidemiologie, Sektion Rehabilitation und Arbeit
    • Mr.  Prof.  Matthias  Bethge 
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • Germany
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    • Universität WürzburgAbteilung für Medizinische Psychologie und Psychotherapie, Medizinische Soziologie und Rehabilitationswissenschaften
    • Mr.  Dr.  Michael  Schuler 
    • Klinikstr. 3
    • 97070  Würzburg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Rentenversicherung Bund
    • Ruhrstr. 2
    • 10709  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/03/31
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Trial Publications, Results and other Documents

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