Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00011303

Trial Description

start of 1:1-Block title

Title

Depression and anxiety in patients with early arthritis – A retrospective observational study in the daily medical practice

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

In this retrospective cross-sectional study the frequency of depression and anxiety disorders in patients with suspicion of an early arthritis. In doing so, influencing factors are taken into account at the time of the first diagnosis position, such as the age, sex, duration of the symptoms and indicators of the disease activity.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

This cross-sectional study (retrospective observation study) determines prevalence of anxiety and depression disorders as determined by the Hospital Anxiety and Depression Scale (HADS) at the time of the initial presentation of patients with the suspicion of an early arthritis in a university ambulance. Further influencing factors, such as e.g. disease activity, rheumatological characteristics (e.g., morning stiffness), age, sex, symptom duration from the daily practice compared to their associations. The investigation according to the German hospital law (Berlin version) in anonymised data evaluation.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00011303
  •   2017/02/03
  •   [---]*
  •   yes
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   M13.0 -  Polyarthritis, unspecified
  •   F43 -  Reaction to severe stress, and adjustment disorders
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Early rheumatoid patients with an inflammatory joint symptom between 4 weeks and 12 months are continuously compared in the HADS
  •   Published reference data on HADS from the normal population
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Historical
  •   Diagnostic
  •   Other
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Prevalence rates of depression and anxiety in early arthritis patients at first visiting by the rheumatologist measured by the Hospital Anxiety and Depression Scale (HADS)

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Comparison of factors influencing both rheumatic disease and depression and anxiety disorders (e.g., indicators of disease activity, age, gender)

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2011/01/01
  •   180
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

age ≥ 18 years; at least one swollen joint; symptoms duration between 4 weeks and 12 months; fully documented HADS questionnaire

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

criteria for early arthritis are not applicable; suspected of trauma, surgery, infections in the area of symptomatic joints

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Charité-Universitätsmedizin BerlinKlinik m.S. Rheumatologie und Klinische Immunologie
    • Ms.  Dr.  Jacqueline   Detert 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Charité-Universitätsmedizin Berlin Klinik m.S.Rheumatologie und Klinische Immunologie
    • Ms.  Dr. med.  Jacqueline  Detert 
    • Chariteplatz 1
    • 10117  Berlin
    • Germany
    end of 1:1-Block address scientific-contact
    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
    • Charité-Universitätsmedizin Berlin Klinik m.S. Rheumatologie und Klinische Immunologie
    • Ms.  Desiree  Freier 
    • Chariteplatz 1
    • 10117  Berlin
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Charité-Universitätsmedizin Berlin, Klinik für Rheumatologie und Klinische Immunologie
    • Ms.  Dr. med.  Jacqueline  Detert 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2015/04/01
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.