Trial document




drksid header

  DRKS00009588

Trial Description

start of 1:1-Block title

Title

General Practice patient´s perspective concerning content and quality of advance directives

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

Trial Acronym

PatimWa

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

The research object is the living will of general practice (GP) patients in doctor’s offices who are collaborating with the University of Bonn. A living will is a legal document in which a person specifies what actions should be taken for their health if they are no longer able to make decisions for themselves because of illness or incapacity. We want to analyze the patient’s knowledge on their living will, their reasons for signing this document and their sources of information by guide-based interview.
As there are no direct qualitative criterias for finishing the document and the German law is stating only the signature with a date there are divergences in the interpretation of this document by relatives and the physicians.
By this means the analysis can show the patient’s point of view of this problematic nature. In the case to see the document it would be possible to see a connection between the sources of information and the living will’s details. This study tries to see the aspects which have an impact on the living will as a document.
The patient’s recruitment is randomized. The inclusion criterias are the full-age, the capacity of giving consent and the ability to speak German fluently.

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

Brief Summary in Scientific Language

Cross-sectional study with guided interviews

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

Organizational Data

  •   DRKS00009588
  •   2015/11/09
  •   [---]*
  •   yes
  •   Approved
  •   297/15, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
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

  •   The recruatation of paritipicants is randomized. The diagnoses are not the object of the study. The examination object is the patient's attitude towards their living will.
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   GP patients in the doctor's offices collaborating with the University of Bonn will be selected representativly. They will be interviewed on the subject advance directive.
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
  •   Health care system
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Patient’s satisfaction after completing the living will surveyed via a 4-point-Likert-Scale from very satisfied to not satisfied at all.

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

Secondary Outcome

Related factors as education, information’s source…

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

  • Doctor's Practice 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2015/11/10
  •   200
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   110   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Full-aged, capable on consent, able to speak german fluently

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

Exclusion Criteria

Under-aged, incapable of giving consent, not speaking German fluently

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Institut für Hausarztmedizin am Universitätsklinikum Bonn
    • Mr.  Prof. Dr. med.  Klaus  Weckbecker 
    • Sigmund-Freud-Str. 25
    • 52127  Bonn
    • 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
    • Institut für Hausarztmedizin am Universitätsklinikum Bonn
    • Ms.  Rieke  Schnakenberg 
    • Siegmund-Freud-Str. 25
    • 53127  Bonn
    • 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
    • Institut für Hausarztmedizin am Universitätsklinikum Bonn
    • Mr.  Vitali  Thiessen 
    • Brandstr. 27
    • 53721  Siegburg
    • 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
    • Institut für Hausarztmedizin am Universitätsklinikum Bonn
    • Mr.  Prof. Dr. med.  Klaus  Weckbecker 
    • Sigmund-Freud-Str. 25
    • 52127  Bonn
    • 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
  •   2016/01/10
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.