Pharmacist-led Intervention to Enhance Medication Adherence in Post-acute Coronary Syndrome Patients in Vietnam
Pharmacist-delivered Multifaceted Intervention to Enhance Medication Adherence Among Post-acute Coronary Syndrome Patients in Vietnam: A Randomised Controlled Trial
1 other identifier
interventional
140
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 23, 2016
CompletedFirst Posted
Study publicly available on registry
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedJune 1, 2016
May 1, 2016
1.1 years
May 23, 2016
May 31, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients adherent to medication at 1 month after discharge as assessed by the Morisky Medication Adherence Scale - 8 items
1 month
Secondary Outcomes (5)
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
Study Arms (2)
Intervention group
EXPERIMENTALThe intervention group will receive the pharmacist-delivered multifaceted intervention with two counselling sessions in addition to usual care.
Control group
NO INTERVENTIONThe control group will receive usual care without the pharmacist-delivered multifaceted intervention.
Interventions
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.
Eligibility Criteria
You may qualify if:
- The investigators include patients who survived during hospitalisation with one of the following diagnoses according to coding of the International Classification of Diseases, 10th revision (ICD-10): unstable angina (I20.0), acute myocardial infarction (I21) or subsequent myocardial infarction (I22)
You may not qualify if:
- Have discharge diagnosis not unstable angina (I20.0), acute myocardial infarction (I21) and subsequent myocardial infarction (I22)
- Currently participate in another medication adherence study
- Discharge without prescription
- Unwilling to participate the study
- Unable to communicate in Vietnamese
- Unable to identify their own medications
- No telephone number
- Have cognitive impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Groningen
Groningen, Provincie Groningen, 9713 AV, Netherlands
Related Publications (1)
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.
PMID: 29977205DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katja Taxis, PhD
Unit PharmacoTherapy, -Epidemiology & -Economics, Faculty of Mathematics and Natural Sciences, University of Groningen, The Netherlands
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Pharmacotherapy and Pharmaceutical Care
Study Record Dates
First Submitted
May 23, 2016
First Posted
June 1, 2016
Study Start
November 1, 2015
Primary Completion
December 1, 2016
Study Completion
February 1, 2017
Last Updated
June 1, 2016
Record last verified: 2016-05