Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00016934

Trial Description

start of 1:1-Block title

Title

Station-equivalent treatment from the user's perspective

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

[---]*

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

Brief Summary in Scientific Language

Explorative qualitative study that examines the experience of patients in hospital equivalent treatment. This form of treatment, which is new for Germany, has not yet been researched from the patients' perspective.
Study participants are patients who have opted for psychiatric acute treatment in their home environment instead of inpatient treatment. The aim of the study is to determine their needs through semi-structured interviews.

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

Organizational Data

  •   DRKS00016934
  •   2019/09/23
  •   [---]*
  •   yes
  •   Approved
  •   19- 1114_1, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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

  •   Acute psychiatric diseases, with need for inpatient treatment
  •   F10 -  Mental and behavioural disorders due to use of alcohol
  •   F20 -  Schizophrenia
  •   F30 -  Manic episode
  •   F40 -  Phobic anxiety disorders
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Patients inside, who are in hospital equivalent treatment, are asked about their motives for wanting to be treated outside the clinic. Furthermore, their experience of inpatient equivalent treatment and the evaluation of the results will be examined by means of semi-structured guideline interviews.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

The aim of the study is to determine the needs of patients undergoing inpatient equivalent treatment. The expectations, experience and results of the treatment will be asked.

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

Secondary Outcome

Satisfaction with inpatient equivalent treatment.

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

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

Recruitment

  •   Actual
  •   2019/05/09
  •   8
  •   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

All psychiatric diagnoses in inpatient equivalent treatment

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

Exclusion Criteria

Acute suicidal tendency,
Primary addiction disease,
Severe cognitive impairment

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Köln
    • Kerpener Str. 62
    • 50924  Köln
    • 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
    • Fachhochschule der Diakonie
    • Mr.  Prof. Dr.  Hermann  Steffen 
    • Bethelweg 8
    • 33617  Bielefeld
    • 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
    • Uniklinik Köln, Klinik für Psychiatrie
    • Johannes  Kirchhof 
    • Kerpener Straße 62
    • 50937  Köln
    • 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
    • Uniklinik Köln, Klinik für Psychiatrie
    • Mr.  Johannes  Kirchhof 
    • 50937  Köln
    • 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
  •   2019/08/24
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.