Trial document




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  DRKS00016045

Trial Description

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Title

Quality of Life and care situation in Tuberous Sclerosis

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Trial Acronym

--

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URL of the Trial

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Brief Summary in Lay Language

Tuberous sclerosis is a genetic disease that affects numerous organ systems and has considerable effects on the person affected and his or her family. So far, only limited information is available on the effects of the disease on the quality of life and living conditions. Knowledge of the quality of life limitations associated with a disease and the costs and impact on the health care system is of immense importance. For the first time in Germany, comprehensive information on the quality of life and care situation of children and adolescents with tuberous sclerosis will be collected. This is done with the help of questionnaires.

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Brief Summary in Scientific Language

Tuberous sclerosis (TSC) is a genetic disease that affects numerous organ systems and has significant effects on the person affected and his or her family. So far, only limited information is available on the effects of the disease on the quality of life and living conditions.
For the first time in Germany, comprehensive information on the quality of life and care situation of children and adolescents with tuberous sclerosis will be collected. This is done with the help of questionnaires on disease costs, resource consumption, quality of life and depression symptoms.

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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

  •   DRKS00016045
  •   2019/03/01
  •   [---]*
  •   yes
  •   Approved
  •   324/18, Ethikkommission des Fachbereichs Humanmedizin der Johann-Wolfgang-Goethe-Universität Frankfurt am Main
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Secondary IDs

  •   U1111-1229-4714 
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Health Condition or Problem studied

  •   Q85.1 -  Tuberous sclerosis
  •   G40 -  Epilepsy
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Interventions/Observational Groups

  •   Patients with TSC (ICD-10 Q85.1) Use of Patient questionnaires
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Characteristics

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

Cost of illness (Questionnaires for health care resource utilization over 3 to 12 month period)

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Secondary Outcome

Quality of Life (KINDL, BDI-II (Beck Depression Inventory), Qolie-31 (Quality of Life in Epilepsy))

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2019/02/28
  •   300
  •   Monocenter 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

ICD-10 diagnosis Q85.1

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Exclusion Criteria

None

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Epilepsiezentrum Frankfurt Rhein-Main
    • Mr.  Prof. Dr.  Adam  Strzelczyk 
    • Schleusenweg 2-16
    • 65208  Frankfurt am Main
    • Germany
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    • Epilepsiezentrum Frankfurt Rhein-Main
    • Mr.  Prof. Dr.  Adam  Strzelczyk 
    • Schleusenweg 2-16
    • 65208  Frankfurt am Main
    • Germany
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    • Epilepsiezentrum Frankfurt Rhein-Main
    • Mr.  Prof. Dr.  Adam  Strzelczyk 
    • Schleusenweg 2-16
    • 65208  Frankfurt am Main
    • Germany
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Sources of Monetary or Material Support

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    • Landes-Offensive zur Entwicklung Wissenschaftlich-ökonomischer Exzellenz (LOEWE) des Hessischen Ministeriums für Wissenschaft und Kunst
    • Rheinstraße 23-25
    • 65185  Wiesbaden
    • 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.