Atrial Fibrillation Clinical Trial
Official title:
The Influence of Pharmacist Interventions on the Effectiveness of Warfarin Treatment in Elderly Patients From Rural Areas
Verified date | July 2017 |
Source | Slaven Falamic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary study goal is to explore the influence of pharmacist interventions on the effectiveness of warfarin treatment in a specific subpopulation.
Status | Completed |
Enrollment | 131 |
Est. completion date | January 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility |
Inclusion Criteria: - Age =65 years - Living site of participant outside the city eg. rural site - Expected duration of warfarin therapy at least 6 months from the inclusion in the study and 3 months before Exclusion Criteria: - Hospitalization - Vegetarianism - Patients not able to provide an informed consent - The use of drug that has an X level of clinical significance of interaction with warfarin according to Lexicomp interact base |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Slaven Falamic |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time in therapeutic range (TTR) | Time in therapeutic range by Rosendaal method (percentage of time in therapeutic range) | 6 months | |
Secondary | Adverse drug reactions | To measure the difference in number and types of adverse drug reactions between the intervention and the control group | 6 months | |
Secondary | Time to adverse drug reaction | To measure the difference in time to adverse drug reactions between the intervention and the control group | 6 months | |
Secondary | International randomised ratio | To measure the difference in patterns of the International randomised ratio between the intervention and the control group | 6 months | |
Secondary | Adherence | To measure the difference in adherence between the intervention and the control group | 6 months | |
Secondary | Quality of life | To measure the difference of the quality of life in the intervention and the control group at the beginning and the end of the study (validated Croatian version of DUKE - Duke anticoagulation satisfaction scale questionaire) | 6 months | |
Secondary | Incidence and influence of clinically significant drug interactions | To measure the incidence of clinically significant drug interactions (defined by the Lexicomp-interact base as degree C and D of clinical significance) and influence of drug interactions on the effectiveness and safety of treatment between the intervention and the control group | 6 months | |
Secondary | Dietary intake of vitamin K | Changes of dietary intake of vitamin K | 6 months | |
Secondary | Acceptance of pharmacist's intervention by the general practitioners | To measure the rate of acceptance of pharmacist's interventions by the general practitioners | 6 months |
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