Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00005595

Trial Description

start of 1:1-Block title

Title

Improvement of diabetes screening in general practice via selection of at-risk patients from medical assistences by the exampla of the FINDRISK-test.

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

Trial Acronym

SeRiFin

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

Background and aim: The intention of the study is to reduce the incidence and the subsequent morbidity of type 2 diabetes. The Finish Diabetes Risc Score (FINDRISC) briefly tests the risk of developing diabetes within the next ten years. Compared to filling in the questionaire on the internet or in a pharmacy, a family practice can offer immediate advice by health care professionals. Intervention (in half of the participating practices): Within 5 weeks, physician assistents in each practice asked 120 patients between 20 and 50 years without a diabetes diagnosis to fill out the FINDRISC-test (control group). In the other half of the participating general practices 60 patients were recruited in each practice. Only patients with obesity and/or a positive family history of diabetes will be asked to participate at the study (intervention group).
Hypothesis: The study examines, wether the average risc score in the intervention group is different to the average score in the control group.

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

Brief Summary in Scientific Language

Type 2 diabetes is one of the major problems for the health care system because of the advanced incidence and the subsequent morbidity. The FINDRISC briefly tests the risk of developing diabetes within the next ten years. Compared to filling out the questionaire on the internet or in a pharmacy, a general practice can offer immediate advice by health care professionals. Patients, that were between 20 an 50 years of age an have not yet been diagnosed with diabetes were asked in their general practice to fill out the FINDRISC-form. The study design is a randomised controlled trial. In the 6 participating general practices, patients that had been diagnosed with obesety and/or had a positive family history were recruited for the intervention group. In the control-group (5 general practices), a representative group of patients were asked to fill out the FINDRISC-form. We are investigating, if the average risc score at the intervention group is different to the average risc score at the control group. The data is being analized at the moment.

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

Organizational Data

  •   DRKS00005595
  •   2014/01/15
  •   [---]*
  •   yes
  •   Approved
  •   195/13, 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

  •   Diabetes Type 2
  •   E11 -  Non-insulin-dependent diabetes mellitus
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Patients in a general practice with a positive family history of diabetes and/or obesity were selected by the physician assistent. These patients at the age of 20 to 50 years were asked to fill out the FINDRIC-form with assistence if needed.
  •   Patients in a general practice without detected diabetes mellitus at the age of 20 to 50 years were recruited. A representative group of patients was asked to fill out the FINDRISC-form with assistence if needed.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Screening
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Average risk score of intervention- and controll group using the FINDRISC-questionnaire

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

Secondary Outcome

[---]*

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
  •   2013/11/18
  •   900
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

No diagnosis of diabetes so far

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

Exclusion Criteria

Diabetes mellitus

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Bonn
    • Mr.  Prof. Dr.  Michael  Rothe 
    • Sigmund-Freud-Straße 25
    • 53127  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
    • Universitätsklinikum Bonn
    • Ms.  MPH  Rieke  Schnakenberg 
    • Sigmund-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
    • Ms.  Inge  Hohl 
    • Sigmund-Freud-Str. 25,
    • 52127  Bonn
    • 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
    • Deutsche Diabetesstiftung
    • Mr.  Prof. Dr.  Rüdiger  Landgraf 
    • Staffelseestraße 6
    • 81477  München
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   089/579579-0
    •   [---]*
    •   [---]*
    •   [---]*
    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
  •   2015/04/15
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  •   R. Schnakenberg, M. Rothe, M. Bleckwenn. Early Selection of At-risk Patients for Type 2 Diabetes in the GP Surgery by Medical Assistants – A Feasibility Study. Gesundheitswesen. 2015 Apr 28. [Epub ahead of print]
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.