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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00006256 |
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Date of registration:
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09/01/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Individual versus general information about certain risks of medication in patients with a high risk for adverse drug reaction
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Scientific title:
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Individual versus general information about certain risks of medication in patients with a high risk for adverse drug reaction - IDrug
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Date of first enrolment:
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29/09/2014 |
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Target sample size:
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960 |
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Recruitment status: |
Recruiting |
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URL:
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http://drks.de/search/en/trial/DRKS00006256 |
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Study type:
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observational |
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Study design:
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Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: prevention
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Name:
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Kathrin
Kastenmüller |
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Address:
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Sigmund-Freud-Straße 25, Haus 303 1. OG, Raum 286
53127
Bonn
Germany |
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Telephone:
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0228 287 13739 |
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Email:
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kkastenm@uni-bonn.de |
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Affiliation:
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Universitätsklinikum Bonn, Institut für Hausarztmedizin |
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Name:
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Kathrin
Kastenmüller |
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Address:
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Sigmund-Freud-Straße 25, Haus 303 1. OG, Raum 286
53127
Bonn
Germany |
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Telephone:
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0228 287 13739 |
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Email:
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kkastenm@uni-bonn.de |
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Affiliation:
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Universitätsklinikum Bonn, Institut für Hausarztmedizin |
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Key inclusion & exclusion criteria
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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
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
Age minimum:
60 Years
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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I74.1
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I74.4
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Pulmonary embolism without mention of acute cor pulmonale
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Embolism and thrombosis of iliac artery
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Other specified coagulation defects
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Acquired coagulation factor deficiency
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coagulation problems,
Bleeding events,
thromboembolic events
D68.30
D68.31
D68.32
D68.38
D68.4
D68.8
I26.0
I26.9
I74.0
I74.1
I74.2
I74.3
I74.4
I74.5
I74.8
I74.9
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D68.8
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D68.31
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D68.32
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Embolism and thrombosis of unspecified artery
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D68.30
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D68.4
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Embolism and thrombosis of arteries of upper extremities
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Embolism and thrombosis of other arteries
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I26.9
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Pulmonary embolism with mention of acute cor pulmonale
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D68.38
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Embolism and thrombosis of other and unspecified parts of aorta
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Embolism and thrombosis of abdominal aorta
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Embolism and thrombosis of arteries of extremities, unspecified
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I74.5
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I74.8
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Embolism and thrombosis of arteries of lower extremities
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I74.2
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I26.0
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I74.9
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I74.0
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I74.3
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Intervention(s)
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Group 1: 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
-.........
Group 2: 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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Primary Outcome(s)
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Bleeding occurence or occurence of a thromboembolic event during the observation period of 9 month
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Secondary Outcome(s)
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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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Secondary ID(s)
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U1111-1164-7207
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Source(s) of Monetary Support
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(BMBF)DLR Grundträger
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Ethics review
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Status: Approved
Approval date: 07/04/2014
Contact:
ethik@ukbonn.de
Ethik-Kommission Medizinische Fakultät Bonn
+49-228-28751282
ethik@ukbonn.de
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