Trial document





This trial has been registered retrospectively.
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  DRKS00016042

Trial Description

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Title

Prediction of return to work and time off work in patients with hand injuries in the rehabilitation management provided by the German Social Accident Insurance

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Trial Acronym

Further development and validation of the Hamburger Prognosescores

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URL of the Trial

https://ihrs-en.ibe.med.uni-muenchen.de/biopsychosocial/currend-projects/prohand/index.html

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Brief Summary in Lay Language

From 2012 to 2016, a pilot study had been carried out at the Department of Hand, Plastic and Microsurgery of the BG Klinikum Hamburg aiming to identify aspects that allow the prediction of return to work of patients treated according to the rehabilitation management of the German Social Accident Insurance. Based on data of nearly 500 patients with hand injuries who attended rehabilitation sessions at the BG Klinikum Hamburg two scores were developed: the Hamburger Prognosescore HandAF (return to work) and the Hamburger Prognosescore HandDAU (time off work). The aim of this current study is to further develop and validate both scores by enlarging the data pool on which they are built on.

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Brief Summary in Scientific Language

From 2012 to 2016, a pilot study had been carried out at the Department of Hand, Plastic and Microsurgery of the BG Klinikum Hamburg aiming to identify aspects that allow the prediction of return to work of patients treated according to the rehabilitation management of the German Social Accident Insurance. Based on data on functioning and contextual factors of nearly 500 patients with hand injuries who attended at least one session in the rehabilitation management at the BG Klinikum Hamburg two scores were developed: the Hamburger Prognosescore HandAF (return to work) and the Hamburger Prognosescore HandDAU (time off work). These scores contribute to the prediction of return to work and time off work of patients with hand injuries at admission to rehabilitation management. The aim of this current study is to further develop and validate both scores by enlarging the data pool on which they are built on. A mono-centre prospective study is carried out at the Department of Hand, Plastic and Microsurgery at the BG Klinikum Hamburg. Data on functioning and contextual factors of 400 patients with simple and complex hand injuries in rehabilitation management are assessed and used to enlarge the data pool for the calculation of both scores. Based on this data pool the precision and predictive power of the scores will be checked, refined and adjusted if needed.

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Organizational Data

  •   DRKS00016042
  •   2018/12/13
  •   [---]*
  •   yes
  •   Approved
  •   PV5138, Ethik-Kommission der Ärztekammer Hamburg
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Secondary IDs

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

  •   S60-S69 -  Injuries to the wrist and hand
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Interventions/Observational Groups

  •   Treatment according to the rehabilitation management of the German statutory insurance system.

    Data collection is performed at admission and discharge of rehabilitation. During rehabilitation data on treatment (e.g., inpatient treatment, physical therapy) are documented.

    At admission the following data are assessed: (1) socio-demographic data, (2) injury-specific data (e.g., localisation and type of injury), (3) functioning using the Disabilities of the Hand, Arm and Shoulder (DASH) questionnaire, (4) additional patient-reported outcomes (e.g., pain), (5) quality of life using the EuroQoL 5D (EQ-5D) and (6) clinical assessment (e.g., muscle power, joint functions). At discharge data on functioning and quality of life as well as the clinical assessment are assessed. In addition, return to work and reduction in earning capacity are documented.

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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Return to work

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Secondary Outcome

Time off work

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2018/09/01
  •   400
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Diagnosis of single and multiple injuries of the hand; at least one rehabilitation session

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Exclusion Criteria

[---]*

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Addresses

  • start of 1:1-Block address primary-sponsor
    • BG Klinikum Hamburg
    • Mr.  Dr. med.  Klaus-Dieter  Rudolf 
    • Bergedorfer Straße 10
    • 21033  Hamburg
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Lehrstuhl für Public Health und Versorgungsforschung, Ludwig-Maximilians-Universität (LMU) München
    • Ms.  Dr.  Michaela  Coenen 
    • Marchioninistr. 17
    • 81377  München
    • Germany
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    • Lehrstuhl für Public Health und Versorgungsforschung
    • Ms.  Michaela  Kirschneck 
    • Marchioninistr. 17
    • 81377  München
    • Germany
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Sources of Monetary or Material Support

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    • DGUV
    • Glinkastraße 40
    • 10117  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.