Trial document




drksid header

  DRKS00013076

Trial Description

start of 1:1-Block title

Title

Digital communication assistance tool for non-German speaking patients in border refugee camp Friedland - a feasibility study

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

Trial Acronym

DICTUM-Friedland

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

URL of the Trial

http://www.dictum.med.uni-goettingen.de/index-en.html

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

Brief Summary in Lay Language

Communication with patients who cannot speak German or speak at best very little is considered one of the biggest challenges facing health care professionals in Germany.
The digital communication assistance tool facilitates collecting a structured medical history from patients in 13 languages and dialects. This happens by giving intuitive input on a Tablet PC, before meeting the doctor (e.g. while in the waiting room). Right after that the doctor gets a translated summary of the history.
The digital communication assistance tool will be tested and evaluated in the primary healthcare center at transit border camp Friedland.
A comparison of persons who use this tool and those who do not use it (people who do not speak any of the 13 languages or do not want for other reasons) may serve to illustrate to what extent the tool improves mutual understanding.

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

Brief Summary in Scientific Language

Communication with patients who cannot speak German or speak at best very little is considered one of the biggest challenges facing health care professionals in Germany.
The digital communication assistance tool facilitates collecting a structured medical history from patients in 13 languages and dialects. This happens by giving intuitive input on a Tablet PC, before meeting the doctor (e.g. while in the waiting room). The tool can automatically encode the consultation reason as ICPC-2 code on the basis of the data entered by the patient. Right after that the doctor gets a translated summary of the history.
The digital communication assistance tool will be tested and evaluated in the primary healthcare center at transit border camp Friedland. The aim will be to analyze the extent to which the digital communication assistance tool improves mutual understanding. The rates of re-consultation as well as the total costs for the general medical care serve as indicators. In addition, we gather the subjective impression of practitioners and patients by means of different questionnaires and several qualitative interviews. Due to decreasing numbers of refugees and existing recruiting problems, we had to adjust the initially estimated number of cases from 2000 to a calculated number of cases of 880.

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

Organizational Data

  •   DRKS00013076
  •   2017/09/29
  •   [---]*
  •   yes
  •   Approved
  •   16/3/17, Ethik-Kommission der Medizinischen Fakultät der Georg-August-Universität Göttingen
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1202-5973 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   primary medical care
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Patients who speak one of the 13 available languages and use the digital communication assistance tool for the purpose of medical history
  •   Patients who do not use the digital communication assistance tool because they do not speak any of the 13 available languages or for other reasons
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Other
  •   Other
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

What?: Applicability and reliability of the digital communication assistance tool

What exactly? Test run without patients: Troubleshooting and verification upon the completeness regarding the questions for medical history
When?: 09/2017 (before use in patients)
How?: Feedback from doctors (in writing, by telephone and verbal = no scientific question only feedback)

AND

What exactly? Consistency of medical impression (clinical picture) and software-generated ICPC-2 code
When?: During the entire duration oft he project
How?: Comparison of the ICPC-2 codes generated by the tool and the medical diagnoses (ICD10)

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

Secondary Outcome

What? Rate of re-consultation, mutual understanding & costs
When?: One year after starting the intervention (11/2018, for all patients)
How?: Registration at each consultation; questionnaires for patients, doctors and practice staff, qualitative interviews with doctors and practice staff

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

  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2017/11/01
  •   880
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

People who use the service of the First Aid Station at the transit border camp Friedland

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

Exclusion Criteria

Patients who do not understand any of the 13 languages / dialects can only participate in the control group

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Institut für Allgemeinmedizin Universitätsmedizin Göttingen
    • Ms.  Prof. Dr.  Eva  Hummers-Pradier 
    • Humboldtallee 38
    • 37073  Göttingen
    • 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 Allgemeinmedizin Universitätsmedizin Göttingen
    • Ms.  PD Dr.  Anne  Simmenroth 
    • Humboldtallee 38
    • 37073  Göttingen
    • 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 scientific-contact
    • Institut für Allgemeinmedizin Universitätsmedizin Göttingen
    • Mr.  Frank  Müller 
    • Humboldtallee 38
    • 37073  Göttingen
    • 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 scientific-contact
    • Institut für Allgemeinmedizin Universitätsmedizin Göttingen
    • Ms.  Dr.  Evelyn  Kleinert 
    • Humboldtallee 38
    • 37073  Göttingen
    • 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 Allgemeinmedizin Universitätsmedizin GöttingenGeorg-August-Universität
    • Ms.  Dr.  Evelyn  Kleinert 
    • Humboldtallee 38
    • 37073  Göttingen
    • 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
    • Robert-Bosch-Stiftung
    • 100628
    • 70005  Stuttgart
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • Niedersächsisches Landesamt für Soziales, Jugend und Familie
    • Theaterplatz 4
    • 37073  Göttingen
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact otherSupport
  • start of 1:1-Block address otherSupport
    • Europäischer Sozialfonds (ESF)
    • Günther-Wagner-Allee 12-16
    • 30177  Hannover
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2018/12/31
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.