Tailored Intervention to Improve Patient Adherence to Secondary Stroke Prevention Medication

This study has been completed.
Sponsor:
Collaborator:
University of Southern Denmark
Information provided by (Responsible Party):
Ulla Hedegaard, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01684176
First received: September 10, 2012
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

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
Stroke
Transient Ischemic Attack
Behavioral: Complex tailored intervention
Behavioral: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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 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 ] [ Designated as safety issue: No ]
  • For antiplatelets, anticoagulants and statins: Percent of patients that are at least 80% adherent (PDC>0.8) [ Time Frame: 1 year from inclusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Medication Adherence to antihypertensives measured by proportion of days covered (PDC) [ Time Frame: One year from inclusion ] [ Designated as safety issue: No ]
  • Percent of patients that are at least 80% adherent (PDC>0.8) to antihypertensives [ Time Frame: One year from inclusion ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Accept rate for thromboprophylactic agents measured by percent of patients starting treatment within 0-90 days after discharge. [ Time Frame: 3 months from discharge ] [ Designated as safety issue: No ]
  • Composite endpoint: stroke, myocardial infarction or cardiovascular death [ Time Frame: One year from inclusion ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01684176

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

No publications provided

Responsible Party: Ulla Hedegaard, PhD student, MSc (pharm), Odense University Hospital
ClinicalTrials.gov Identifier: NCT01684176     History of Changes
Other Study ID Numbers: AKF-381
Study First Received: September 10, 2012
Last Updated: June 20, 2014
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

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

Additional relevant MeSH terms:
Cerebral Infarction
Ischemic Attack, Transient
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014