COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Tailored Intervention to Improve Patient Adherence to Secondary Stroke Prevention Medication

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01684176
Recruitment Status : Completed
First Posted : September 12, 2012
Last Update Posted : January 21, 2015
University of Southern Denmark
Information provided by (Responsible Party):
Ulla Hedegaard, Odense University Hospital

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.

Condition or disease Intervention/treatment Phase
Stroke Transient Ischemic Attack Behavioral: Complex tailored intervention Behavioral: Usual care Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 211 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pharmacist Intervention Programme to Improve Medication Adherence in Stroke Patients
Study Start Date : August 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Medication Adherence to antiplatelets, anticoagulants and statins measured by proportion of days covered (PDC). [ Time Frame: One year from inclusion ]
  2. 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 :
  1. Medication Adherence to antihypertensives measured by proportion of days covered (PDC) [ Time Frame: One year from inclusion ]
  2. Percent of patients that are at least 80% adherent (PDC>0.8) to antihypertensives [ Time Frame: One year from inclusion ]
  3. 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 ]
  4. Accept rate for thromboprophylactic agents measured by percent of patients starting treatment within 0-90 days after discharge. [ Time Frame: 3 months from discharge ]
  5. Composite endpoint: stroke, myocardial infarction or cardiovascular death [ Time Frame: One year from inclusion ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01684176

Layout table for location information
Odense University Hospital
Odense C, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
University of Southern Denmark

Additional Information:
Layout table for additonal information
Responsible Party: Ulla Hedegaard, PhD student, MSc (pharm), Odense University Hospital Identifier: NCT01684176    
Other Study ID Numbers: AKF-381
First Posted: September 12, 2012    Key Record Dates
Last Update Posted: January 21, 2015
Last Verified: January 2015
Keywords provided by Ulla Hedegaard, Odense University Hospital:
Ischemic Attack, Transient
Medication adherence
Motivational interviewing
Stroke prevention
Additional relevant MeSH terms:
Layout table for MeSH terms
Ischemic Attack, Transient
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Ischemia