- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01684176
Tailored Intervention to Improve Patient Adherence to Secondary Stroke Prevention Medication
January 19, 2015 updated by: Ulla Hedegaard, Odense University Hospital
Pharmacist Intervention Programme to Improve Medication Adherence in Stroke Patients
Patient suffering a Transient Ischemic Attack (TIA) or stroke are subsequently at high risk of a new stroke, however, poor adherence to secondary prevention medications occurs frequently within this patient group.
The purpose of this study is to evaluate whether a complex tailored pharmacist intervention will lead to increased adherence to secondary stroke prevention medications and less new stroke events when compared to a usual care group.
Interventions focus on motivational interviewing, medication review and telephone follow up.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
211
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Odense C, Denmark, 5000
- Odense University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age: 18 years or older
- Patient admitted or receiving ambulatory treatment for an acute transient ischemic attack or ischemic stroke which has occurred within the previous 30 days.
- The patient or a carer usually dispenses the patient's medications
- Written consent
Exclusion Criteria:
- Cognitive or physical impairment that would preclude comprehension of a conversation
- Terminal illness
- Lives in a care home or an institution
- Receives dose dispensed medicine from a pharmacy
- Medicine is dispensed by a nurse in the patient's home
- Correctional mental health patients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Usual care
|
|
Experimental: Complex tailored intervention
The intervention consists of 3 elements:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Medication Adherence to antiplatelets, anticoagulants and statins measured by proportion of days covered (PDC).
Time Frame: One year from inclusion
|
One year from inclusion
|
For antiplatelets, anticoagulants and statins: Percent of patients that are at least 80% adherent (PDC>0.8)
Time Frame: 1 year from inclusion
|
1 year from inclusion
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Medication Adherence to antihypertensives measured by proportion of days covered (PDC)
Time Frame: One year from inclusion
|
One year from inclusion
|
Percent of patients that are at least 80% adherent (PDC>0.8) to antihypertensives
Time Frame: One year from inclusion
|
One year from inclusion
|
Non-persistence with thromboprophylactic agents ( antiplatelets, anticoagulants, statins and antihypertensives) measured by percent of patients that are not supplied with medication for more than 3 continuous months
Time Frame: One year from inclusion
|
One year from inclusion
|
Accept rate for thromboprophylactic agents measured by percent of patients starting treatment within 0-90 days after discharge.
Time Frame: 3 months from discharge
|
3 months from discharge
|
Composite endpoint: stroke, myocardial infarction or cardiovascular death
Time Frame: One year from inclusion
|
One year from inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Actual)
February 1, 2013
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
September 10, 2012
First Submitted That Met QC Criteria
September 10, 2012
First Posted (Estimate)
September 12, 2012
Study Record Updates
Last Update Posted (Estimate)
January 21, 2015
Last Update Submitted That Met QC Criteria
January 19, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AKF-381
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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