Systematic Follow up of Drug Treatment by Pharmacists in Secondary Prevention After Transient Ischemic Attack
1 other identifier
interventional
265
1 country
6
Brief Summary
Use of drugs is an important factor in secondary prophylaxis after transient ischemic attack (TIA), but studies show that adherence to the prescribed drugs is often poor. This randomised controlled trial aims to investigate whether a systematic follow up of drug treatment using medication reconciliation, medication reviews and patient counselling by clinical pharmacists, improves adherence and/or decreases cardiovascular events the first three months and the first year after TIA. Patient satisfaction will also be compared between the two groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2012
Longer than P75 for not_applicable
6 active sites
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
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 13, 2014
CompletedFirst Posted
Study publicly available on registry
March 17, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedMarch 30, 2017
March 1, 2017
2.8 years
March 13, 2014
March 29, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
adherence to drug treatment in secondary prevention after TIA
self reporting of adherence
3 months
Secondary Outcomes (9)
adherence to drug treatment in secondary prevention after TIA
1 year
Persistence
3 months
Incidence of stroke and cardiovascular events and deaths
3 months
degree of disability or dependence in the daily activities
3 months
patient satisfaction
3 months
- +4 more secondary outcomes
Study Arms (2)
drug use counselling
EXPERIMENTALPharmacist conducting drug reconciliation, medication reviews and drug use counselling during hospitalisation. Follow up telephone calls 1 week, 1 month, 2 months and three months after discharge from hospital
Control group
NO INTERVENTIONThe patients in the control group receive no intervention just treatment and follow up according to national standards
Interventions
Eligibility Criteria
You may qualify if:
- Probable or possible transient ischemic attack
- Residing in Central Norway
- Examined within 2 weeks after the onset of symptoms
- Modified Rankin Scale 3 or less and living at home
- enrolled in the MIDNOR-TIA study NCT02038725
- Informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Norwegian University of Science and Technologylead
- St. Olavs Hospitalcollaborator
- Helse Midt-Norgecollaborator
- Sykehusapotekene i Midt Norgecollaborator
Study Sites (6)
Ålesund Sykehus
Ålesund, Norway
Kristiansund Sykehus
Kristiansund, Norway
Levanger Sykehus
Levanger, Norway
Molde Sykehus
Molde, Norway
Namsos Sykehus
Namsos, Norway
St Olavs Hospital
Trondheim, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bent Indredavik, PhD, Prof
Norwegian University of Science and Technology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2014
First Posted
March 17, 2014
Study Start
November 1, 2012
Primary Completion
September 1, 2015
Study Completion
June 1, 2016
Last Updated
March 30, 2017
Record last verified: 2017-03