Trial document




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  DRKS00000586

Trial Description

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Title

Video-assisted education program for patients with oral anticoagulant treatment – Protocol of a cluster-randomized controlled study

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Trial Acronym

S.A.V.E.

save anticoagulation with video-assisted education

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URL of the Trial

http://www.allgemeinmedizin.med.uni-goettingen.de/de/content/forschung/510_117.html

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Brief Summary in Lay Language

Aim of this study is to develop a education program for patients with oral anti-coagulation therapy in the primary care. Our education program is a video-assisted, which will be done by practice nurses. Our education program should optimize the use and safety of oral anticoagulation therapy and to reduce the complication and costs.

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Brief Summary in Scientific Language

cluster-randomized controlled study to evaluate the long-term effects of a video-assisted education program about oral anticoagulation in comparison to a patient information brochure only

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Organizational Data

  •   DRKS00000586
  •   2010/12/09
  •   [---]*
  •   yes
  •   Approved
  •   2/9/10, Ethik-Kommission der Medizinischen Fakultät der Georg-August-Universität Göttingen
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Secondary IDs

  •   U1111-1118-3464 
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Health Condition or Problem studied

  •   Z92.1 -  Personal history of long-term (current) use of anticoagulants
  •   I26 -  Pulmonary embolism
  •   I63 -  Cerebral infarction
  •   I80 -  Phlebitis and thrombophlebitis
  •   Z29.9 -  Prophylactic measure, unspecified
  •   I48.19 -  [generalization I48: Atrial fibrillation and flutter]
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Interventions/Observational Groups

  •   intervention group: 180 patients who will attend a video-assisted education program for oral anticoagulation consisting of a video, individual education and a brochure.
  •   control group: 180 patients who will recieve a brochure only.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Other
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

The aim of this study is to improve patient knowledge about oral anticoagulation. The primary outcome is the number of correctly answered questions from the questionnaire which assesses the knowledge about oral anticoagulation. This questionnaire will be filled out at the beginning of the study, after 4 weeks and after 6 months of patients from both study arms.

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Secondary Outcome

Secondary outcomes are time spent in therapeutic range, subjective feeling of safety and complications related to OAT.
We will evaluate patient records for INR-level in the last 12 months and complications in the patient history in the last 6 months.Subjective feeling of safety will be evaluated by a questionnaire after 6 months.All data will be collected by the practice nurses and will be sent coded to our study center.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2011/01/03
  •   360
  •   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

The inclusion criteria are:
- patients aged 18 or over, receiving OAT and are willing to participate in the study
- in case of dependent patients both they and their care-givers (e.g. care-giving relatives) are willing

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Exclusion Criteria

Exclusion criteria are:
- inability to give informed consent and no care giver willing to participate in the study
- nursing home residents
- patients only seen in cross cover practices
- patients insufficient to command of German language.

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Addresses

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    • Abteilung Allgemeinmedizin Universitätsmedizin Göttingen
    • Mr.  Prof. Dr. med.  Jean-Francois  Chenot 
    • Humboldt-Allee
    • 37073  Göttingen
    • Germany
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    • Abteilung AllgemeinmedizinUniversitätsmedizin Greifswald
    • Mr.  Prof. Dr. med.  Jean-Francois  Chenot 
    • Humboldtallee 38
    • 17475  Greifswald
    • Germany
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    • Abteilung AllgemeinmedizinUniversitätsmedizin Greifswald
    • Mr.  Prof. Dr. med.   Jean-François   Chenot 
    • Fleischmannstr. 42
    • 17475  Greifswald
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2011/03/31
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* This entry means the parameter is not applicable or has not been set.