Tailored Intervention to Improve Patient Adherence to Secondary Stroke Prevention Medication

Stroke Clinical Trial

Official title:

Pharmacist Intervention Programme to Improve Medication Adherence in Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01684176
• Other study ID #: AKF-381
• Status: Completed
• Phase: N/A
• First received: September 10, 2012
• Last updated: January 19, 2015
• Start date: August 2012
• Est. completion date: June 2014

Study information

• Verified date: January 2015
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: June 2014
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Ischemic Attack, Transient
• Stroke
• Transient Ischemic Attack

Intervention

Behavioral:
• Complex tailored intervention

• Usual care

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense C

Sponsors (2)

Lead Sponsor	Collaborator
Odense University Hospital	University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Hedegaard U, Kjeldsen LJ, Pottegård 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication Adherence to antiplatelets, anticoagulants and statins measured by proportion of days covered (PDC).		One year from inclusion	No
Primary	For antiplatelets, anticoagulants and statins: Percent of patients that are at least 80% adherent (PDC>0.8)		1 year from inclusion	No
Secondary	Medication Adherence to antihypertensives measured by proportion of days covered (PDC)		One year from inclusion	No
Secondary	Percent of patients that are at least 80% adherent (PDC>0.8) to antihypertensives		One year from inclusion	No
Secondary	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	No
Secondary	Accept rate for thromboprophylactic agents measured by percent of patients starting treatment within 0-90 days after discharge.		3 months from discharge	No
Secondary	Composite endpoint: stroke, myocardial infarction or cardiovascular death		One year from inclusion	No

External Links

•   Multifaceted Intervention Including Motivational Interviewing to Support Medication Adherence after Stroke/Transient Ischemic Attack: A Randomized Trial.