Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00016032

Trial Description

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Title

Depressive symptoms and association with disease activity, pain and disability in juvenile patients with chronic rheumatic diseases

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Trial Acronym

/

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URL of the Trial

http:///

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Brief Summary in Lay Language

All patients in pediatric rheumatologic care receive a screening for depressive symptoms with the BDI-FS (Beck Depressions-Inventar - Fast Screen for medical patients) at least yearly. Patients with depressive symptoms have the possibility to be psychologically evaluated to ascertain diagnosis of manifest depression. The groups of patient with depressive symptoms / manifest depression will be compared to the patients with a normal BDI-FS score regarding parameters listed in endpoints.

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Brief Summary in Scientific Language

All patientd in pediatric rheumatologic care receive a Screening for depressive symptoms with the BDI-FS at least yearly. Patients with depressive symptoms have the possibility to be psychologically evaluated to ascertain diagnosis of manifest Depression. The Groups of Patient with depressive symptoms / manifest Depression will be compared to the patients with a normal BDI-FS score to analyze associations between Depression and Parameters like Age, gender, disease activity, treatment and other Parameters.

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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

  •   DRKS00016032
  •   2019/01/10
  •   [---]*
  •   yes
  •   No approval required according to EC
  •   [---]*, Ethikkommission der Ärztekammer Nordrhein
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Secondary IDs

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

  •   juvenile idiopathic arthritis
  •   M08 -  Juvenile arthritis
  •   other rheumatic diseases
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Interventions/Observational Groups

  •   Patients aged 10-18 years of all genders, who are regularly visiting pediatric rheumatologic care routinely receive a screening for depressive symptoms with the BDI-FS (Beck Depressions-Inventar - Fast Screen for medical patients) at least yearly. Patients with depressive symptoms have the possibility to be psychologically evaluated to ascertain diagnosis of manifest depression. Patient characteristics such as disease activity, therapy, gender, age, disability will be compared between patient with depressive symptoms / manifest depression will and patients with a normal BDI-FS score.
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Characteristics

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

Prevalence of symptoms of depressive mood and suicidal tendency in juvenile patients with chronic rheumatic disease.
Measured by BDI FS (Beck Depressions-Inventar - Fast Screen for medical patients) once yearly in clinical routine.
Prevalence of definite depression and suicidality in this patient group.

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Secondary Outcome

To assess correlations of depressive symptoms and definite depression with
o disease activity
o diagnosis
o pain
o disability
o age
o gender
o concomitant disease
o therapy

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2018/09/20
  •   300
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

diagnosis of chronic rheumatic disease

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Exclusion Criteria

none

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Addresses

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    • Asklepios Klinik Sankt AugustinZentrum für Kinder-und Jugendmedizin
    • Mr.  Prof Dr.med.  Gerd  Horneff 
    • Arnold-Janssen-Str.29
    • 53757  Sankt Augustin
    • Germany
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    • Asklepios Klinik Sankt Augustin
    • Ms.  Dr.  Ariane  Klein 
    • Arnold-Janssen-Str. 29
    • 53757  Sankt Augustin
    • Germany
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    • Asklepios Klinik Sankt Augustin
    • Ms.  Dr.  Ariane  Klein 
    • Arnold-Janssen-Str. 29
    • 53757  Sankt Augustin
    • Germany
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    end of 1:1-Block address contact public-contact
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Sources of Monetary or Material Support

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    • Rosemarie-Germscheid Stiftung
    • Donaustrasse 13
    • 56567  Neuwied
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2019/07/01
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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.