Pharmacist-delivered Multifaceted Intervention to Enhance Medication Adherence Among Post-acute Coronary Syndrome Patients in Vietnam: A Randomised Controlled Trial
Sponsor study identifier
interventional
140
1 country
1
Study Start
November 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Adherence to treatment in post-acute coronary syndrome patients has been found to be poor in several studies. Pharmacists play a significant role in enhancing medication adherence and reducing rates of mortality and re-admission to hospital by performing medication reconciliation and tailoring, and patient education. The purpose of this study is to determine the effect of pharmacist-delivered multifaceted intervention on medication adherence and clinical outcomes of post-acute coronary syndrome patients. The study will be designed as a randomised controlled trial with blinded outcome assessors. The population includes patients who survive during hospitalisation with discharge diagnosis of acute coronary syndrome. Pharmacist-delivered multifaceted intervention consists of two counselling sessions within 1 week before and after hospital discharge including medication reconciliation and tailoring, and support with pill organiser and drug information leaflet. Primary outcome measure is the proportion of patients adherent to medication at 1 month after discharge. Secondary outcome measures are the proportions of patients (1) adherent to medication at 3 months after discharge, (2) readmitted to hospital and (3) dying within 3 months after discharge. The investigators also measure (4) the change in quality of life and (5) beliefs about medicines from baseline at 3 months.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2015
Date type not reportedThis date has not been verified as actual or estimated.
May 23, 2016
Actual (reported)June 1, 2016
Actual (reported)December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Proportion of patients adherent to medication at 1 month after discharge as assessed by the Morisky Medication Adherence Scale - 8 items
1 month
Proportion of patients adherent to medication at 3 months after discharge as assessed by the Morisky Medication Adherence Scale - 8 items
3 months
Proportion of patients readmitted to hospital of any cause at 3 months.
3 months
Proportion of patients dying of any cause at 3 months.
3 months
Change in quality of life from baseline assessed with EuroQol questionnaire EQ-5D-3L at 3 months.
Baseline and 3 months
Change in beliefs about medicines from baseline assessed with the Beliefs about Medicines Questionnaire (BMQ) at 3 months.
Baseline and 3 months
The intervention group will receive the pharmacist-delivered multifaceted intervention with two counselling sessions in addition to usual care.
The control group will receive usual care without the pharmacist-delivered multifaceted intervention.
First counselling: A pharmacist performs a 30-minute in-person counselling within 1 week before discharge including: (1) assessment and giving advice on basic knowledge of acute coronary syndrome: definition, risk factors, possible cardiac events, and prevention; (2) assessment of past experiences of using medications, encouragement and tailored advice; (3) providing support with pill organiser and drug information leaflet; (4) teaching back and correcting misunderstanding. Second counselling: A pharmacist performs a 30-minute telephone counselling within 1 week after discharge including: (1) assessment of general and medication-related issues patients concerning; (2) encouragement and tailored advice; (3) teaching back and correcting misunderstanding.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Groningen
Groningen, Provincie Groningen, 9713 AV, Netherlands
Nguyen T, Nguyen TH, Nguyen PT, Tran HT, Nguyen NV, Nguyen HQ, Ha BN, Pham TT, Taxis K. Pharmacist-Led Intervention to Enhance Medication Adherence in Patients With Acute Coronary Syndrome in Vietnam: A Randomized Controlled Trial. Front Pharmacol. 2018 Jun 21;9:656. doi: 10.3389/fphar.2018.00656. eCollection 2018.
Katja Taxis, PhD
Unit PharmacoTherapy, -Epidemiology & -Economics, Faculty of Mathematics and Natural Sciences, University of Groningen, The Netherlands
First Submitted
May 23, 2016
First Posted
June 1, 2016
Study Start
November 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Contact the study team to confirm eligibility.
December 2016
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 1, 2016
Record last verified: 2016-05
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