Trial document





This trial has been registered retrospectively.
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  DRKS00006315

Trial Description

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Title

Hypertension Management in Primary Care: "Getting research into practice"

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Blood pressure control is important to decrease morbidity and mortality, e.g. due to myocardial infarction and stroke. Scientific studies showed that organizational interventions such as patient recall systems and the combination of non-pharmacological treatment with intensified medication increased blood pressure control and decreased mortality. This cluster randomized trial evaluates the effectiveness of a medical education series for primary care physicians about a modern hypertension management on blood pressure control in patients with high blood pressure.

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Brief Summary in Scientific Language

Evaluation of the effectiveness of a physician-centered medical education program about hypertension management on blood pressure control of hypertensive patients in primary care.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00006315
  •   2014/07/14
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  •   yes
  •   Approved
  •   13-5537-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

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Health Condition or Problem studied

  •   I10-I15 -  Hypertensive diseases
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Interventions/Observational Groups

  •   Intervention: Evidence-based three-part medical education program for general practitioners on hypertension management; core elements: 1) training on valid upper arm blood pressure readings, 2) evidence-based information on resistant hypertension, secondary hypertension, and modern pharmacotherapy, and 3) introduction and distribution of practice tools to facilitate the long-term implementation of hypertension management.
  •   Control: Physicians receive the intervention after completion of the follow-up data collection.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control
  •   Health care system
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Blood pressure control rate measured by 24-hour blood pressure readings (blood pressure is measured before the intervention and three months after the last medical education session)

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Secondary Outcome

Changes in average systolic and diastolic 24-hour blood pressure; implemented practice redesign elements such as patient recall systems, standardized sheets, disease-specific information leaflets, predefined practice procedures for hypertension management.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2013/09/26
  •   100
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Hypertension according to international guidelines (office readings ≥140/90 mmHg, 24-hour ambulatory measurement ≥130/80 mmHg, and/or mean home measurements ≥135/85 mmHg based on a one week protocol with at least 2 measurements daily), with and without hypertension-related diseases

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Exclusion Criteria

Unable to give informed consent, not able to read and comprehend the German language

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Addresses

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    • Institut für Allgemeinmedizin, Universitätsklinikum Essen, Universität Duisburg-Essen
    • Mr.  Prof. Dr. med.  Stefan  Gesenhues 
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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    •   0201-877 869-0
    •   0201-877-869-20
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    • Institut für Allgemeinmedizin, Universitätsklinikum Essen, Universität Duisburg-Essen
    • Ms.  Priv.-Doz. Dr. med.  Birgitta  Weltermann, MPH(USA) 
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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    • Institut für Allgemeinmedizin, Universitätsklinikum Essen
    • Ms.  Priv.-Doz. Dr. med.   Birgitta   Weltermann, MPH(USA) 
    • Hufelandstraße 55
    • 45147  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Ministerium für Innovation, Wissenschaft und Forschung des Landes Nordrhein-Westfalen
    • 40221  Düsseldorf
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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