Trial document




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  DRKS00013037

Trial Description

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Title

Influence of clinical discharge recommendations and their implementation on professional integration of patients after brain surgey

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The explorative study investigates the impact of clinical discharge procedures on the life of brain-operated patients. The aim is to describe the influence of discharge recommendations for further treatment (e. g. rehabilitation) and of recommendations for support measures (e. g. professional reintegration) on the occupational participation of brain-operated patients. Likewise, possible gaps in care at the transition from inpatient to outpatient setting are to be uncovered. The group of subjects consists of 70 patients aged between 18 and 65 years after resection of a benign brain tumour (meningioma, pituitary adenoma, glioma). The patients were professionally active or undergoing training before the operation or prior to diagnosis. In the quantitative part of the study, 60 patients will be questioned on a standardized questionnaire on relevant facts, such as the recommendations they have received retrospectively at the Clinic for Neurosurgery and during further treatment. In this context, the focus will continue to be on questions of recasting recommendations and the professional situation. In the qualitative part, the professional situation is examined in more detail by means of a guideline interview. The underlying survey instrument is the WHO Disability Assessment Schedule (WHODAS 2.0), which is supplemented by its own questions. Half of the patients are interviewed in the course of the three-month post-operative examination and the other half during the fifteen-month check-up in the clinic in person and by telephone. In addition, the discharge letters are analysed for recommendations for further treatment as part of the study.

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Brief Summary in Scientific Language

The explorative study investigates the impact of clinical discharge procedures on the life of brain-operated patients. The aim is to describe the influence of discharge recommendations for further treatment (e. g. rehabilitation) and recommendations for support measures (e. g. professional reintegration) on the occupational experience of brain-operated patients. Similarly, possible gaps in care at the transition from inpatient to outpatient care are to be uncovered. The group of subjects consists of 70 patients aged between 18 and 65 years after resection of a benign brain tumour (meningioma, pituitary adenoma, glioma). The patients were employed or undergoing training before the operation or prior to diagnosis. In the quantitative part of the study, 60 patients will be questioned on a standardized questionnaire on relevant facts, such as the recommendations they have received retrospectively at the Clinic for Neurosurgery and during further treatment. In this context, the focus will continue to be on questions of recasting recommendations and the professional situation.

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Organizational Data

  •   DRKS00013037
  •   2017/10/16
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  •   yes
  •   Approved
  •   429/17, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   D35 -  Benign neoplasm of other and unspecified endocrine glands
  •   D32 -  Benign neoplasm of meninges
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Interventions/Observational Groups

  •   In the quantitative part of the exploratory study, 60 patients are questioned about relevant facts such as received and implemented recommendations by means of a standardized questionnaire. In the qualitative part, barriers and supportive conditions for the post-operative work life of 10 patients are analysed using a standardized guideline interview. The WHO Disability Assessment Schedule (WHODAS 2.0) is used to measure the occupational participation situation and the severity of functional impairments. It is supplemented by an own questions on the perception of health, received and implemented recommendations and on the employment relationship. In addition, the discharge letters will be analysed for recommendations for further treatment as part of the study. The interview takes place in the course of the three-month post-operative examination and in the other half during the fifteen-month post-operative check-up at the clinic in person and by telephone.
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Health care system
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The primary endpoint is professional participation, which is measured with the domain domain "work or school activities" of the WHO Disability Assessment Schedule (WHODAS 2.0), 36-Item version, Interviewer Questionnaire three and fifteen months postoperatively.

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Secondary Outcome

Remaining in the preoperative profession (or training course, study goal), the current work level in comparison with preoperative or before diagnosis and the general health perception, which are measured three and fifteen months post-operative by an own made standardized questionnaire.
The degree of impairment, which is also measured three and fifteen months post-operative with the domains "cognition / perception, mobility and self-sufficiency" of the WHO Disability Assessment Schedule (WHODAS 2.0), 36-Item version, Interviewer Questionnaire.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/10/01
  •   70
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Resection of a benign brain tumour of the following types: glioma and/or meningeoma and/or pituitary adenoma.
Previous surgery at the time of the survey: three and/or fifteen months. Occupational, in vocational or academic training before the operation or diagnosis. Consentable patients.

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Exclusion Criteria

- More than just one brain surgery
- Radiation treatment of the head
- preoperative non-tumour-related epilepsy
- preoperative and/or current neurodegenerative disease
-Preoperative and/or actual severe chronic or terminal complications Disease (e. g. cancer)
- Patients who are unable to give their consent
- preoperative severe mental illness
- Preoperative existing Care Level
- Preoperative degree of disability from 50

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Addresses

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    • Uniklinik Freiburg - Klinik für Neurochirurgie
    • Breisacherstrasse 64
    • 79106  Freiburg
    • Germany
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    • Neurochirurgische Klinik, Uniklinikum Freiburg
    • Mr.  Dr. med.  Mukesch Johannes  Shah 
    • Breisacherstrasse 64
    • 79106  Freiburg
    • Germany
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    • Neurochirurgische Klinik, Uniklinikum Freiburg
    • Mr.  Dr. med.  Mukesch Johannes  Shah 
    • Breisacherstrasse 64
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Uniklinik Freiburg - Klinik für Neurochirurgie
    • Breisacherstrasse 64
    • 79106  Freiburg
    • Germany
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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.