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

Recruiting

• Conditions: coagulation problems,Bleeding events,thromboembolic events; D68.30; D68.31; D68.32; D68.38; D68.4; D68.8; I26.0; I26.9; I74.0

• Registration Number: DRKS00006256
• Lead Sponsor: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 960

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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.<br>mortality: number of death during the observation period of 9 month.<br>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)<br>