Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00006256

Trial Description

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Title

Individual versus general information about certain risks of medication in patients with a high risk for adverse drug reaction

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Trial Acronym

IDrug

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In cooperation with general practitioners, clinical pharmacologists and pharmaeconomist it will be tested, whether and to what extent a risk information about drug treatment including the individual situation of the patient (including biological and genetical factors) will be superior to a standardized risk information about the drug treatment. In this study it should be tested, whether an individual risk assessment, that is being generated by a clinical pharmacologist , who includes the individual pharmacological situation of the patient (co-medication, pharmacogentetics, renal function, age) will be superior to a standardized information that does not take the individual situation about the patient into account. It should be also tested, whether this individual risk assessment will be cost effectiv. There will be no direction given to change the treatment. We only analyse the effect that this information (individual vs standardized) will have on the number of adverse events. Over the time of 9 month it will be monitored what effect the type of risk information will have concerning the number of visits to a doctors office, hospitalization, changes of medication, and the quality of life of the patient. The goal is to reduce the number of adverse events of patients that are on risk to have severe adverse event, which in turn will lead to an improved the quality of life. Also the safety of the drug therapy should be improved with the help of this information.
To this point we don’t know if an information including individual factors like pharmacogenetical diagnostics, pharmacological interactions, age and renal function is superior to an standardized information and if the time and effort to prepare such an individual analysis will be worth while. If there will be no benefit of the individualized information one would have to reconsider the development of individualized informationtools to improve individualized therapy.
There will be 870 patients from 40-80 offices of general practitioners altogether, that will be randomized to be part of either study arm. Both patient and general practitioner will receive a writen version of the risk information (standardized or individual), which was created with programs that have been developed by experts. At the beginning of the study a blood sample will be taken for pharmacogentical testing and the patient is required to fill in several questionaires to get information about the quality of life, the adherence of the medication and their social background. With each of the following visits and at the end of the study it will be documented if there were any adverse drug reactions or bleeding – or thromboembolic events. Also the patientes will fill in a questionaire about their overall health once every 3 month.

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Brief Summary in Scientific Language

We want to answer the question if patients that have drug- related adverse events can benefit from an individualized information about their health. Can such a individualized information about their risk to have an unwanted side effect lead to the improvement of the safety of the pharmacotherapy and can the number of adverse effects be reduced.

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Organizational Data

  •   DRKS00006256
  •   2015/01/09
  •   [---]*
  •   yes
  •   Approved
  •   318/13, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
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Secondary IDs

  •   U1111-1164-7207 
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Health Condition or Problem studied

  •   coagulation problems,
    Bleeding events,
    thromboembolic events
  •   D68.30 -  [generalization D68.3: Haemorrhagic disorder due to circulating anticoagulants]
  •   D68.31 -  [generalization D68.3: Haemorrhagic disorder due to circulating anticoagulants]
  •   D68.32 -  [generalization D68.3: Haemorrhagic disorder due to circulating anticoagulants]
  •   D68.38 -  [generalization D68.3: Haemorrhagic disorder due to circulating anticoagulants]
  •   D68.4 -  Acquired coagulation factor deficiency
  •   D68.8 -  Other specified coagulation defects
  •   I26.0 -  Pulmonary embolism with mention of acute cor pulmonale
  •   I26.9 -  Pulmonary embolism without mention of acute cor pulmonale
  •   I74.0 -  Embolism and thrombosis of abdominal aorta
  •   I74.1 -  Embolism and thrombosis of other and unspecified parts of aorta
  •   I74.2 -  Embolism and thrombosis of arteries of upper extremities
  •   I74.3 -  Embolism and thrombosis of arteries of lower extremities
  •   I74.4 -  Embolism and thrombosis of arteries of extremities, unspecified
  •   I74.5 -  Embolism and thrombosis of iliac artery
  •   I74.8 -  Embolism and thrombosis of other arteries
  •   I74.9 -  Embolism and thrombosis of unspecified artery
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Interventions/Observational Groups

  •   The following parameters will be included in the individualized pharmacotherapeutical risk information:
    - genetical analysis (CYP2C9, CYP2C19, VCORC1)
    - drug- drug interaction test
    - liver values and other lab values

    There will be no given direction to change the drug therapy. The doctor can act as he thinks is best for the patient. Every 3 month (3 times ) there will be consultations with the patient, where the patients will be ask about their general health. The patients will be ask the following questions, just to list a few:
    - number of sick certifcates
    - number of specialist's referral
    - number of admissions to a hosital
    - accidents (traffic, in the house, at work,....)
    - operations
    - invasive examination (e.g. catheter)
    - allergic reactions
    - headache
    - nausea
    -.........

  •   Patients that get the standardized risk information will get informed in detail about their liver values and other values, that were measured in the lab. Also they will get detailed information again about the meaning of oral anticoagulation. The treatment will be according to current medical standards including additional standardized information on risk factors for adverse drug effects. Every 3 month ( 3 times altogteher) the patients are ask for their health status. the following paramters are being documented:
    - number of sick certifcates
    - number of specialist's referral
    - number of admissions to a hosital
    - accidents (traffic, in the house, at work,....)
    - severe adverse drug reactions
    - Number of hospital admissions due to adverse drug effects
    - Number of specialist consultations due to problems in drug therapy
    - Number of medication changes during obsevation period
    - etc. ....
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Other
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Bleeding occurence or occurence of a thromboembolic event during the observation period of 9 month

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Secondary Outcome

morbidity: serious adverse drug reaction during the observation period of 9 month. Number of hospitailzation due to serious adverse drug reaction. Number of specialist's referral due do problems with the medication. Number of change in medication during the observation period of 9 month.
mortality: number of death during the observation period of 9 month.
Effectiveness: qualtiy of life (SF-36; 3,6, and 9 month after start of the study). Cost of medication and of potantil additional doctor’s visit. cost-benefit analysis (that takes mobidity and mortality into account)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2014/09/29
  •   960
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

multimorbidity, therapy with oral anticoagulation, minimum of one additional medication over a longer period of time, can give written consent to take part in the study

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Exclusion Criteria

is not able to give consent ot take part in that study, is not able to understand and/or fill in the questionaire SF-36 and other forms

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
    • Ms.  Prof. Dr. med.  Julia  Stingl 
    • Kurt-Georg-Kiesinger-Allee 3
    • 53175  Bonn
    • Germany
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    • Universitätsklinikum Bonn, Institut für Hausarztmedizin
    • Ms.  Dr.rer.nat.  Kathrin  Kastenmüller 
    • Sigmund-Freud-Straße 25, Haus 303 1. OG, Raum 286
    • 53127  Bonn
    • Germany
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    • Universitätsklinikum Bonn, Institut für Hausarztmedizin
    • Ms.  Dr.rer.nat.  Kathrin  Kastenmüller 
    • Sigmund-Freud-Straße 25, Haus 303 1. OG, Raum 286
    • 53127  Bonn
    • Germany
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Sources of Monetary or Material Support

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    • (BMBF)DLR Grundträger
    • Ms.  Dr.  Nicola   Grundmann 
    • Heinrich-Konen-Straße 1
    • 53227  Bonn
    • Germany
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    •   0228 3821 1682
    •   0228 3821 1257
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    •   [---]*
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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.