Trial document





This trial has been registered retrospectively.
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  DRKS00015120

Trial Description

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Title

BGM-innovativ - Workplace, cross-provider Healthcare management of company health insurance funds

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Trial Acronym

[---]*

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URL of the Trial

https://www.bkk-dachverband.de/gesundheit/gesundheitsfoerderung-selbsthilfe/betriebliche-gesundheitsfoerderung-bgf/bgm-innovativ/

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Brief Summary in Lay Language

BGM-innovativ for employees with musculoskeletal disorders is a response to the specific needs for healthcare in companies. The objective of the program is to offer sick or vulnerable employees targeted support tailored to their individual needs during recovery and the provision of healthcare. BGM-innovativ intends to establish close cooperation and coordination between the relevant health insurance carriers, pension providers and companies. The program aims to avoid disease and chronification, reduce disease duration and days of absence and to permanently maintain capacity for work. Companies and employees will be supported in the field of corporate healthcare management (BGM) by healthcare management oriented to each individual workplace situation. BGM-innovativ has a multimodal structure and intends to establish workplace-relevant, individualized and cross-sector healthcare measures. Depending on the stage of the disease and the impact on the employee, these measures may be early intervention, rehabilitation or reintegration.

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Brief Summary in Scientific Language

BGM-innovativ for employees with musculoskeletal disorders is a response to the specific needs for healthcare in companies. The objective of the program is to offer sick or vulnerable employees targeted support tailored to their individual needs during recovery and the provision of healthcare. BGM-innovativ intends to establish close cooperation and coordination between the relevant health insurance carriers, pension providers and companies. The program aims to avoid disease and chronification, reduce disease duration and days of absence and to permanently maintain capacity for work. Companies and employees will be supported in the field of corporate healthcare management (BGM) by healthcare management oriented to each individual workplace situation. BGM-innovativ has a multimodal structure and intends to establish workplace-relevant, individualized and cross-sector healthcare measures. Depending on the stage of the disease and the impact on the employee, these measures may be early intervention, rehabilitation or reintegration.
The design of the study employs a mixed-method approach and consists of both an accompanying, process-oriented (formative) and a result-oriented (summative) evaluation. We use a randomized-controlled trial with accompanying focus group discussions and expert interviews.

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Organizational Data

  •   DRKS00015120
  •   2018/08/08
  •   [---]*
  •   yes
  •   Approved
  •   17-171, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

  • [---]*
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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

  •   coordinated case Management in three modules

    Module A:
    Target Group are patients with (sub-/chronic) MSD. Inclusion criteria are MSD disorders, no abnormal absent days. Rsk of disease progress with inappropriate health behavior.

    Measures in Module A:
    - job-related baseline test (EFL), PACT, cardiovascular test (IPN-test), David-Test, BMI
    - 3 months of training based on an individual plan (min. 2 training sessions/weeks)
    - final examination


    Modul B:
    Target group: insurees with moderate-severe MSD. Inability to work (-6 weeks or frequent shorter absent periods), workability is endangered.

    Measures in Module B:
    - job-related Rehabilitation (multimodal orthopedic rehabilitation following the quality criteria of the German Pension insurance)
    - medical examination and Job description (occupational medicine)
    - EFK-test, 2x EFL-training, additional training depending on specific job demands (10 sessions/3 weeks)
    - allday outpatient or inpatient in a Rehabilitation facility (authorized by the German Pension insurance to deliver MBOR)
    - job-related Training and psychosocial Intervention (1-3 single sessions à 45 min, 2 module à 60 min, 1 relaxation session).
    - standardized release report


    Module C:
    Target group: insurees with severe MSD. Absent days over 6 weeks, comorbidity possible. Close to Job loss.

    Measures in Module C:
    - detailed job description by occupational physician
    - if necessary: additional medical examinations
    - 2-days ambulatory measure (EFL-test), psychological examination
    - orthopedic expert opinion

    In all modules: detailed consultation with case Manager.
  •   assisted self-management in three modules

    In all modules: detailed consultation with case Manager, semi-standardized Information material, elastic gym band.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   data analyst
  •   Active control (effective treament of control group)
  •   Health care system
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

workability (Workability-Index) and absent days at work (routine data delivered by participating company health insurance funds)

Study participants receive a standardized questionnaire directly after informed consent (baseline) and after intervention (approx. 6 months)

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Secondary Outcome

quantitative:
pain (Deutscher Schmerzfragebogen)
self-efficacy (Skala zur Allgemeinen Selbstwirksamkeitserwartung), exploratie Analysis of additional outcomes (e.g. functional tests)

qualitative:
focus group discussion with case managers and expert interviews with company physicians

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
  • other 
  • other 
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Recruitment

  •   Actual
  •   2017/08/08
  •   350
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

General inclusion criteria:
M-diagnosis (ICD-10) with or without inability to work, principal ability to work, member of one the participating company health insurance funds


Additionally, depending on module:
Module A: Employees with beginning musculoskeletal condition, diagnosed, beginning functional restrictions, no or low rate of absent days (up to 14 days), not suitable for medical rehabilitation according to DRV
Module B: criteria according to DRV for medical rehabilitation fulfilled (§26 SGB IX), pronounced incapacity to work (frequent short absence rates or absent rates up to 4 weeks),
Module C: employee with severe musculoskeletal disorders, severe condition, potentially threathened job loss, reintegration in question, possibly comorbidities, long absent rates (more than 6 weeks).

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Exclusion Criteria

not suitable for rehabilitation (concerning Module B and C), M-diagnosis M00.0-00.9, M01.0-01.8, M02.0-02.9, M03.0-03.6, M08.0-08.9, M09.0- 09.8, M20.0-20.6, M30-36, M46.0-46.9, M60.0-60.9, M61.0-61.9, M62.0-62.9, M63.0- 63.8, M80.0-80.9, M84.0-84.9, M87.0-87.9, M88.0-M88.9, M90.0-90.8

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Addresses

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    • IMVR - Institut für Medizinsoziologie, Versorgungsforschung und Rehabilitationswissenschaft, Humanwissenschaftliche Fakultät und Medizinische Fakultät, Universität zu Köln
    • Mr.  Prof. Dr.  Holger  Pfaff 
    • Eupener Straße 129
    • 50933  Köln
    • Germany
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    • IMVR - Institut für Medizinsoziologie, Versorgungsforschung und Rehabilitationswissenschaft, Humanwissenschaftliche Fakultät und Medizinische Fakultät, Universität zu Köln
    • Ms.  Dr.  Kyung-Eun (Anna)  Choi 
    • Eupener Str. 129
    • 50933  Köln
    • Germany
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    • BKK Dachverband
    • Mr.  MPH  Thomas  Moormann 
    • Mauerstraße 85
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Innovationsfonds des Gemeinsamen Bundesausschusses
    • Wegelystr. 8
    • 10623  Berlin
    • Germany
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.