Trial document




This trial has been registered retrospectively.
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  DRKS00011709

Trial Description

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Title

Quality Assurance of Invasive Measures for Treatment of Parkinson Patients in Clinical Routine in Germany

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Trial Acronym

QualiPa – THS

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URL of the Trial

http://www.epidemiologie.uni-wuerzburg.de/projekte/quali_pa/

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Brief Summary in Lay Language

The idiopathic Parkinson’s syndrome is one of the most frequent neurological diseases in higher age. It is
characterized by an advancing neurodegenerative course of disease. For some years now, there are a
number of new therapeutic options for the treatment of the Parkinson’s disease which are able to
postpone long-term complications. These include innovative invasive treatment methods such as intrajejunal infusion therapy L-Dopa for the treatment of Morbus Parkinson, continuous subcutaneous
pump application of apomorphine as well as deep brain stimulation at an advanced stage of Morbus
Parkinson.
These invasive therapeutic methods are technically complex and require a high level of expertise.
However, these therapeutic methods are not part of an established quality assurance program yet. So the
project intends to establish sustainable structures in order to ensure a high quality treatment for patients
with Parkinson’s syndrome treated by one of the innovative invasive treatment methods in Germany.

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Brief Summary in Scientific Language

Background and state of research
Idiopathic Parkinson's syndrome is one of the most common neurological diseases of the elderly, with an
estimated number of 1.2 to 2 million people in Europe. Due to the aging of our society, an increase in the
absolute number of patients with Parkinson's syndrome is expected. For a number of years, a number of
new therapies for the treatment of Parkinson's syndrome have been available, which can postpone the
occurrence of late complications. This also includes innovative invasive therapy methods, e.g. The
intrajejunal infusion therapy L-Dopa for the treatment of Parkinson's disease in the advanced stage, the
continuous subcutaneous pump application of apomorphine in selected indications, and the deep brain
stimulation in advanced stages of Parkinson's disease. The invasive therapy methods mentioned are
technically complex and require a high level of expertise of the participating institutions with regard to
their application. Since these novel therapies are currently not part of statutory quality
assurance procedures, there are no data on the implementation of these measures in clinical practice in
Germany. For this reason, sustainable structures are to be established within the scope of the following
project in order to document the quality of the medical care of patients with Parkinson's Syndrome who
are recruited by means of one of the innovative therapeutic procedures in Germany.
In a first step, a voluntary quality assurance register is established for the process of deep brain
stimulation, in which information about patients undergoing a DBS intervention is collected from
institutions throughout the Federal territory. The basis for this is the quality indicators previously
developed by a multidisciplinary board, which are used to describe the quality of care and to carry out an
external comparison of the quality of the participating institutions in the sense of benchmarking.

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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

  •   DRKS00011709
  •   2017/07/27
  •   [---]*
  •   yes
  •   Approved
  •   235/15, Ethik-Kommission der Medizinischen Fakultät der Universität Würzburg
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Secondary IDs

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

  •   G20 -  Parkinson disease
  •   OPS 5-014.9
  •   OPS 5-028.9
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Interventions/Observational Groups

  •   Detection of the treatment quality in a questionnaire of Parkinsonpatients, which are adjusted stationary with THS.
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Characteristics

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

Assessment of the treatment quality of Parkinsonian patients who are stationed with THS.
The purpose of the study / register is the recording and presentation of the treatment quality of deep brain stimulation in patients with Parkinson's disease

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Secondary Outcome

not specified

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/11/11
  •   1600
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Idiopathic Parkinson's syndrome (ICD-10 code: G20.-),
THS intervention: Stereotactic initial implantation of intracerebral microelectrodes (OPS: 5-014.9-) and neurostimulators (OPS: 5-028.9-)

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Exclusion Criteria

age < 18 yaers, no idopatic Parkinsonsyndrom, preexisting deep brain stimulation

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Addresses

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    • Institut für Klinische Epidemiologie und Biometrie (IKE-B) Universität Würzburg
    • Mr.  Prof. Dr  Peter Ulrich  Heuschmann 
    • Josef-Schneider-Str. 2 / Haus D7
    • 97080  Würzburg
    • Germany
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    • Universitätsklinikum WürzburgNeurologischen Klinik und Poliklinik
    • Mr.  Prof. Dr.  Jens  Volkmann 
    • Josef-Schneider-Straße 11
    • 97080  Würzburg
    • Germany
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    • Institut für Klinische Epidemiologie und Biometrie (IKE-B) der Universität Würzburg
    • Ms.  Dr.  Kirsten  Haas 
    • Josef-Schneider-Str. 2
    • 97080  Würzburg
    • Germany
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    end of 1:1-Block address contact scientific-contact
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    • Universitätsklinikum Würzburg
    • Mr.  Dr. med  Philip  Capetian 
    • Josef-Schneider-Str. 11
    • 97080  Würzburg
    • Germany
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    • Institut für Klinische Epidemiologie und Biometrie (IKE-B) der Universität Würzburg
    • Ms.  Dr.  Kirsten  Haas 
    • Josef-Schneider-Str. 2
    • 97080  Würzburg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Parkinson Gesellschaft e. V.
    • Reinhardtstr. 27 C
    • 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.