Trial document





This trial has been registered retrospectively.
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  DRKS00007823

Trial Description

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Title

Cardiovascular prevention: project to improve cooperation between general practitioners and occupational physicians

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Trial Acronym

KaPräKo-Study

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim of the study is to identify the needs of a common cardiovascular prevention of occupational doctors and general practitioners in a medium-sized enterprises. For this, the total cardiovascular risk is calculated using the PROCAM score. From a medium risk in the next 10 years to suffer a heart attack or stroke is a medical interview on cardiovascular prevention meaningful.

The study will take place in the company TRIMET aluminum SE. There, about 750 employees. Employees are investigated as usual by the company doctor in the context of occupational medical examinations according to BG principles. In the context of occupational health examination, the offer is made to participate in the study and answered questions. Is he agree to participate in the study, he gets a personal study questionnaire. This includes questions about medical history, family history and wishes for preventive measures. Part 1 of the questionnaire will be reviewed by the company doctor for completeness and discussed with the employee.This is followed by the company doctor documenting the measured values listed in Part 2 of the study questionnaire (height, weight, abdominal and hip circumference, RR measurements, medications).
Based on the measured values of the individual risk for a heart attack or stroke within the next 10 years is determined for the volunteers. The calculations use the PROCAM Quick test (http://www.assmann-stiftung.de/procam-studie/procam-tests/). Based on the calculated cardiovascular risk classification of the subjects carried out in three categories low (0-10% *), medium (10-20% *) or high (> 20% *) risk. In a blood test may be dispensed with in the rapid test used.
The calculated risk area is communicated to the participants by the company doctor at the end of the investigation. If necessary, the subject and / or the family doctor about necessary therapies to be informed. At the express request of the subject, a direct contact between operating and GP could be done.

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Brief Summary in Scientific Language

Through a risk detection, preventive measures can be initiated targeted. The "Gesundheitsuntersuchung" is the first investigation to the family doctor, in which a risk evaluation is performed. However, taking only 17 percent of those eligible participated in this study. Most patients in this examination are older than 55 years. These patients have mostly chronic diseases such as hypertension or diabetes mellitus. For many patients, the company doctor is the first point of contact. By integration of the company doctor sequelae could be avoided by early initiation of a health-conscious behavior.

In the project "ÄrBeK - Doctors and operation as a partner" of the Bertelsmann Foundation, the detection of cardiovascular risk factors and classified into risk classes as a way to improve cooperation between general practitioners and occupational physician was seen. Patients with an average risk should, in consultation with the general practitioner targeted preventive measures to be offered in-house. At increased risk should a guideline-based therapy such as drug therapy of dyslipidemia be started. In addition to prevention programs to motivate behavior change such as Smoking cessation are offered to employees. A concrete implementation of this concept has not yet taken place.

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Organizational Data

  •   DRKS00007823
  •   2015/02/25
  •   [---]*
  •   yes
  •   Approved
  •   200/14, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   I25.0 -  Atherosclerotic cardiovascular disease, so described
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Interventions/Observational Groups

  •   Calculation of the overall CV risk with the Procam score and information of the family physician in an increased risk to the patient's request
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Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prevention
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Total cardiovascular risk: Percentage risk for a heart attack or stroke in the next 10 years. Calculation and information on the risk after the implementation of the medical history and physical examination of the patient. Calculation with the PROCAM score.

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Secondary Outcome

The nature and extent of in-house prevention services that are desired by employees.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2014/11/01
  •   250
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

Employees of the studied company
Written informed consent

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Exclusion Criteria


Intellectual limitation to participate in the study

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Institut für Hausarztmedizin der Universität Bonn
    • Mr.  Prof. Dr.  Klaus  Weckbecker 
    • Sigmund-Freud-Str. 25
    • 53127  Bonn
    • Germany
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    • Institut für Hausarztmedizin der Universität Bonn
    • Mr.  Prof. Dr.  Klaus  Weckbecker 
    • Sigmund-Freud-Str. 25
    • 53127  Bonn
    • Germany
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    • Institut für Hausarztmedizin der Universität Bonn
    • Mr.  Prof. Dr.  Klaus  Weckbecker 
    • Sigmund-Freud-Str. 25
    • 53127  Bonn
    • Germany
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Sources of Monetary or Material Support

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    • Institut für Hausarztmedizin der Universität Bonn
    • Mr.  Prof. Dr.  Klaus  Weckbecker 
    • Sigmund-Freud-Str. 25
    • 53127  Bonn
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.