NCT01684176

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
211

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 10, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 12, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

January 21, 2015

Status Verified

January 1, 2015

Enrollment Period

6 months

First QC Date

September 10, 2012

Last Update Submit

January 19, 2015

Conditions

StrokeTransient Ischemic Attack

Keywords

StrokeIschemic Attack, TransientMedication adherenceMotivational interviewingStroke prevention

Outcome Measures

Primary Outcomes (2)

  • Medication Adherence to antiplatelets, anticoagulants and statins measured by proportion of days covered (PDC).

    One year from inclusion

  • For antiplatelets, anticoagulants and statins: Percent of patients that are at least 80% adherent (PDC>0.8)

    1 year from inclusion

Secondary Outcomes (5)

  • Medication Adherence to antihypertensives measured by proportion of days covered (PDC)

    One year from inclusion

  • Percent of patients that are at least 80% adherent (PDC>0.8) to antihypertensives

    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

    One year from inclusion

  • Accept rate for thromboprophylactic agents measured by percent of patients starting treatment within 0-90 days after discharge.

    3 months from discharge

  • Composite endpoint: stroke, myocardial infarction or cardiovascular death

    One year from inclusion

Study Arms (2)

Complex tailored intervention

EXPERIMENTAL

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 interventionBehavioral: Usual care

Usual care

PLACEBO COMPARATOR

Usual care

Behavioral: Usual care

Interventions

Complex tailored interventionBEHAVIORAL
Complex tailored intervention
Usual careBEHAVIORAL
Complex tailored interventionUsual care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense C, 5000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 25598772BACKGROUND

MeSH Terms

Conditions

StrokeIschemic Attack, TransientMedication Adherence

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain IschemiaPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student, MSc (pharm)

Study Record Dates

First Submitted

September 10, 2012

First Posted

September 12, 2012

Study Start

August 1, 2012

Primary Completion

February 1, 2013

Study Completion

June 1, 2014

Last Updated

January 21, 2015

Record last verified: 2015-01

Locations

DK(1)