Clinical trial NCT01684176: Tailored Intervention to Improve Patient Adherence to Secondary Stroke Prevention Medication
Official title: Pharmacist Intervention Programme to Improve Medication Adherence in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Transient Ischemic Attack
Keywords: Stroke
Ischemic Attack, Transient
Medication adherence
Motivational interviewing
Stroke prevention
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
First posted: 2012-09-12
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Medication Adherence to antiplatelets, anticoagulants and statins measured by proportion of days covered (PDC).
timeFrame: One year from inclusion
measure: For antiplatelets, anticoagulants and statins: Percent of patients that are at least 80% adherent (PDC>0.8)
timeFrame: 1 year from inclusion
Secondary outcomes:
measure: Medication Adherence to antihypertensives measured by proportion of days covered (PDC)
timeFrame: One year from inclusion
measure: Percent of patients that are at least 80% adherent (PDC>0.8) to antihypertensives
timeFrame: One year from inclusion
measure: 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
timeFrame: One year from inclusion
measure: Accept rate for thromboprophylactic agents measured by percent of patients starting treatment within 0-90 days after discharge.
timeFrame: 3 months from discharge
measure: Composite endpoint: stroke, myocardial infarction or cardiovascular death
timeFrame: One year from inclusion
Other outcomes:
Locations:
city: Odense C
country: Denmark
facility: Odense University Hospital
Study officials:
References:
citation: Hedegaard U, Kjeldsen LJ, Pottegard A, Bak S, Hallas J. Multifaceted intervention including motivational interviewing to support medication adherence after stroke/transient ischemic attack: a randomized trial. Cerebrovasc Dis Extra. 2014 Dec 11;4(3):221-34. doi: 10.1159/000369380. eCollection 2014 Sep-Dec.