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Tailored Intervention to Improve Patient Adherence to Secondary Stroke Prevention Medication

This study has been completed.
University of Southern Denmark
Information provided by (Responsible Party):
Ulla Hedegaard, Odense University Hospital Identifier:
First received: September 10, 2012
Last updated: January 19, 2015
Last verified: January 2015
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.

Condition Intervention
Transient Ischemic Attack
Behavioral: Complex tailored intervention
Behavioral: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pharmacist Intervention Programme to Improve Medication Adherence in Stroke Patients

Resource links provided by NLM:

Further study details as provided by Ulla Hedegaard, Odense University Hospital:

Primary Outcome Measures:
  • Medication Adherence to antiplatelets, anticoagulants and statins measured by proportion of days covered (PDC). [ Time Frame: 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 ]

Secondary Outcome Measures:
  • Medication Adherence to antihypertensives measured by proportion of days covered (PDC) [ Time Frame: One year from inclusion ]
  • Percent of patients that are at least 80% adherent (PDC>0.8) to antihypertensives [ Time Frame: 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 ]
  • Accept rate for thromboprophylactic agents measured by percent of patients starting treatment within 0-90 days after discharge. [ Time Frame: 3 months from discharge ]
  • Composite endpoint: stroke, myocardial infarction or cardiovascular death [ Time Frame: One year from inclusion ]

Enrollment: 211
Study Start Date: August 2012
Study Completion Date: June 2014
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Complex tailored intervention

The intervention consists of 3 elements:

  1. Medication review with recommendations focused on antithrombotics and adherence to guidelines and patient´s adherence to medications.
  2. Discharge consultation with an pharmacist using motivational interviewing techniques.
  3. Follow-up telephone calls one week, two months and six months after discharge.
Behavioral: Complex tailored intervention Behavioral: Usual care
Placebo Comparator: Usual care
Usual care
Behavioral: Usual care


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01684176

Odense University Hospital
Odense C, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
University of Southern Denmark
  More Information

Additional Information:
Responsible Party: Ulla Hedegaard, PhD student, MSc (pharm), Odense University Hospital Identifier: NCT01684176     History of Changes
Other Study ID Numbers: AKF-381
Study First Received: September 10, 2012
Last Updated: January 19, 2015

Keywords provided by Ulla Hedegaard, Odense University Hospital:
Ischemic Attack, Transient
Medication adherence
Motivational interviewing
Stroke prevention

Additional relevant MeSH terms:
Ischemic Attack, Transient
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Ischemia processed this record on May 25, 2017