Tailored Intervention to Improve Patient Adherence to Secondary Stroke Prevention Medication

Not Applicable

Completed

• Conditions: Stroke; Transient Ischemic Attack
• Interventions: Behavioral: Complex tailored intervention; Behavioral: Usual care

• Registration Number: NCT01684176
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-09-10
• Study First Submitted QC: 2012-09-10
• Study First Posted: 2012-09-12
• Primary Completion: 2013-02
• Study Completion: 2014-06
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-19
• Last Update Posted: 2015-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 211

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Complex tailored intervention	Usual care	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.
Complex tailored intervention	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.
Usual care	Usual care	Usual care

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense C, Denmark