Pharmacist Interventions in Rural Elderly Warfarin Patients

Atrial Fibrillation Clinical Trial

Official title:

The Influence of Pharmacist Interventions on the Effectiveness of Warfarin Treatment in Elderly Patients From Rural Areas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03212898
• Other study ID #: SFalamic
• Status: Completed
• Phase: N/A
• First received: July 4, 2017
• Last updated: July 6, 2017
• Start date: May 2015
• Est. completion date: January 2017

Study information

• Verified date: July 2017
• Source: Slaven Falamic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary study goal is to explore the influence of pharmacist interventions on the effectiveness of warfarin treatment in a specific subpopulation.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cardiac Failure
• Heart Failure
• Hemorrhage
• Thrombosis

Intervention

Other:
• anticoagulation care
Patients in the intervention group will: 1) have a repeated pharmacist-led education on all aspects of warfarin treatment; 2) receive enhanced medication instructions and a care and follow up plan; 3) receive a pill box 4) be refered to the GP with proposal for dose change when outside the therapeutic range or therapy modification to avoid drug interactions with warfarin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Slaven Falamic

Outcome

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