Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00010593

Trial Description

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Title

Healthdamages, mental disorders and health care needs of thalidomide affected individuals in North-Rhine-Westfalia

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Trial Acronym

N/A

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URL of the Trial

http://N/A

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Brief Summary in Lay Language

[---]*

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Brief Summary in Scientific Language

OBJECTIVE:
To determine the prevalence of somatic diseases and mental disorders in accordance with ICD-10 in thalidomide-affected men and women.

DESIGN:
Cross-sectional study.

SETTING:
The study targeted all thalidomide-affected people in North Rhine-Westphalia, Germany (n=837).

MAIN OUTCOME MEASURES:
The nature and extent of somatic diseases and mental disorders according to ICD-10.

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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

  •   DRKS00010593
  •   2016/06/07
  •   [---]*
  •   yes
  •   Approved
  •   2011286, Ethikkommission der Ärztekammer Nordrhein
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Secondary IDs

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

  •   Q86.80 -  [generalization Q86.8: Other congenital malformation syndromes due to known exogenous causes]
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Interventions/Observational Groups

  •   Physical-orthopädic examination and psychodiagnostic interview, to detect Thalidomid related damages (orthopädic follow hurts, chronic pain Syndromes and psychiatric komorbidity).

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Characteristics

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

To determine Thalidomide related follow hurts

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Secondary Outcome

none

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2011/11/02
  •   200
  •   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

Q86.80

Thalidomide-Embryopathy,

currently living or were born in NRW.

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Exclusion Criteria

non Thalidomide-Embryopathy

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Dr. Becker Rhein-Sieg-Klinik
    • Mr.  Prof. Dr.  Klaus  Peters 
    • Höhenstraße 30
    • 51588  Nümbrecht
    • Germany
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  • start of 1:1-Block address scientific-contact
    • Dr. Becker Rhein-Sieg Klinik
    • Mr.  Prof. Dr.  Klaus  Peters 
    • Höhenstraße 30
    • 51588  Nümbrecht
    • Germany
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    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Dr. Becker Rhein-Sieg Klinik
    • Mr.  Prof. Dr.  Klaus  Peters 
    • Höhenstraße 30
    • 51588  Nümbrecht
    • Germany
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Sources of Monetary or Material Support

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    • Landeszentrum Gesundheit Nordrhein-Westfalen (LZG.NRW)
    • Gesundheitscampus 9
    • 44801  Bochum
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2013/05/01
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Trial Publications, Results and other Documents

  •   Niecke A, Peters K, Samel C, Forster K, Lüngen M, Pfaff H, Albus C (2017). Mental disorders in people affected by thalidomide: a cross-sectional study of prevalence and psychosocial needs [Psychische Störungen bei Menschen mit Conterganschädigung – Eine Querschnittstudie zu Prävalenz und psychosozialem Versorgungsbedarf]. Dtsch Arztebl Int 114(10):168-74 DOI: 10.3238/arztebl.2017.0168
  •   Lüngen M, Albus C, Niecke A, Samel C, Pfaff H, Peters K (2017). Kosten gesundheitlicher Versorgung contergangeschädigter Menschen – eine aktuelle Neubewertung. Gesundheitsökonomie und Qualitätsmanagement. Accepted 05.12.2016
  •   Niecke A, Peters K, Samel C, Klabes K, Lüngen M, Pfaff H, Albus C (2016). Komorbide psychische Störungen und psychosozialer Versorgungsbedarf von conterganbetroffenen Menschen (Abstract Top-Poster-Session) E-book: http://react-profile.org/ebook/Psycho2016/Abstractbook/ (Seite 173)
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* This entry means the parameter is not applicable or has not been set.