Pharmacist Interventions in Rural Elderly Warfarin Patients
The Influence of Pharmacist Interventions on the Effectiveness of Warfarin Treatment in Elderly Patients From Rural Areas
1 other identifier
interventional
131
0 countries
N/A
Brief Summary
The primary study goal is to explore the influence of pharmacist interventions on the effectiveness of warfarin treatment in a specific subpopulation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable atrial-fibrillation
Started May 2015
Shorter than P25 for not_applicable atrial-fibrillation
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
July 4, 2017
CompletedFirst Posted
Study publicly available on registry
July 11, 2017
CompletedJuly 11, 2017
July 1, 2017
1.7 years
July 4, 2017
July 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time in therapeutic range (TTR)
Time in therapeutic range by Rosendaal method (percentage of time in therapeutic range)
6 months
Secondary Outcomes (8)
Adverse drug reactions
6 months
Time to adverse drug reaction
6 months
International randomised ratio
6 months
Adherence
6 months
Quality of life
6 months
- +3 more secondary outcomes
Study Arms (2)
Intervention
EXPERIMENTALSpecific pharmacist-led anticoagulation care
Control
NO INTERVENTIONThe control group will receive usual care; no interventions will be administered.
Interventions
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
Eligibility Criteria
You may qualify if:
- Age ≥65 years
- Living site of participant outside the city eg. rural site
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Slaven Falamićlead
Related Publications (1)
Falamic S, Lucijanic M, Ortner-Hadziabdic M, Marusic S, Bacic-Vrca V. Pharmacists' interventions improve health-related quality of life of rural older person on warfarin: a randomized controlled trial. Sci Rep. 2021 Nov 9;11(1):21897. doi: 10.1038/s41598-021-01394-0.
PMID: 34754004DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Slaven Falamić, MPharm
Pharmacy Branka Marušić
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Slaven Falamić,MPharm, Prinicipal-Investigator
Study Record Dates
First Submitted
July 4, 2017
First Posted
July 11, 2017
Study Start
May 1, 2015
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
July 11, 2017
Record last verified: 2017-07