search
Back to results

Tailored Intervention to Improve Patient Adherence to Secondary Stroke Prevention Medication

Primary Purpose

Stroke, Transient Ischemic Attack

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Complex tailored intervention
Usual care
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke focused on measuring Stroke, Ischemic Attack, Transient, Medication adherence, Motivational interviewing, Stroke prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Odense University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Complex tailored intervention

Usual care

Arm Description

The intervention consists of 3 elements: Medication review with recommendations focused on antithrombotics and adherence to guidelines and patient´s adherence to medications. Discharge consultation with an pharmacist using motivational interviewing techniques. Follow-up telephone calls one week, two months and six months after discharge.

Usual care

Outcomes

Primary Outcome Measures

Medication Adherence to antiplatelets, anticoagulants and statins measured by proportion of days covered (PDC).
For antiplatelets, anticoagulants and statins: Percent of patients that are at least 80% adherent (PDC>0.8)

Secondary Outcome Measures

Medication Adherence to antihypertensives measured by proportion of days covered (PDC)
Percent of patients that are at least 80% adherent (PDC>0.8) to antihypertensives
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
Accept rate for thromboprophylactic agents measured by percent of patients starting treatment within 0-90 days after discharge.
Composite endpoint: stroke, myocardial infarction or cardiovascular death

Full Information

First Posted
September 10, 2012
Last Updated
January 19, 2015
Sponsor
Odense University Hospital
Collaborators
University of Southern Denmark
search

1. Study Identification

Unique Protocol Identification Number
NCT01684176
Brief Title
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

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
Collaborators
University of Southern Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Transient Ischemic Attack
Keywords
Stroke, Ischemic Attack, Transient, Medication adherence, Motivational interviewing, Stroke prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
211 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Complex tailored intervention
Arm Type
Experimental
Arm Description
The intervention consists of 3 elements: Medication review with recommendations focused on antithrombotics and adherence to guidelines and patient´s adherence to medications. Discharge consultation with an pharmacist using motivational interviewing techniques. Follow-up telephone calls one week, two months and six months after discharge.
Arm Title
Usual care
Arm Type
Placebo Comparator
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
Complex tailored intervention
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Primary Outcome Measure Information:
Title
Medication Adherence to antiplatelets, anticoagulants and statins measured by proportion of days covered (PDC).
Time Frame
One year from inclusion
Title
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 Measure Information:
Title
Medication Adherence to antihypertensives measured by proportion of days covered (PDC)
Time Frame
One year from inclusion
Title
Percent of patients that are at least 80% adherent (PDC>0.8) to antihypertensives
Time Frame
One year from inclusion
Title
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
Title
Accept rate for thromboprophylactic agents measured by percent of patients starting treatment within 0-90 days after discharge.
Time Frame
3 months from discharge
Title
Composite endpoint: stroke, myocardial infarction or cardiovascular death
Time Frame
One year from inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Odense University Hospital
City
Odense C
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
25598772
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.
Results Reference
background

Learn more about this trial

Tailored Intervention to Improve Patient Adherence to Secondary Stroke Prevention Medication

We'll reach out to this number within 24 hrs