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Pharmacist-led Intervention to Enhance Medication Adherence in Post-acute Coronary Syndrome Patients in Vietnam

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02787941
Recruitment Status : Unknown
Verified May 2016 by Katja Taxis, University of Groningen.
Recruitment status was:  Recruiting
First Posted : June 1, 2016
Last Update Posted : June 1, 2016
Sponsor:
Collaborator:
Ho Chi Minh City University of Medicine and Pharmacy
Information provided by (Responsible Party):
Katja Taxis, University of Groningen

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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Medication Adherence Behavioral: Pharmacist-delivered multifaceted intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Pharmacist-delivered Multifaceted Intervention to Enhance Medication Adherence Among Post-acute Coronary Syndrome Patients in Vietnam: A Randomised Controlled Trial
Study Start Date : November 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : February 2017

Arm Intervention/treatment
Experimental: Intervention group
The intervention group will receive the pharmacist-delivered multifaceted intervention with two counselling sessions in addition to usual care.
Behavioral: 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.


No Intervention: Control group
The control group will receive usual care without the pharmacist-delivered multifaceted intervention.



Primary Outcome Measures :
  1. Proportion of patients adherent to medication at 1 month after discharge as assessed by the Morisky Medication Adherence Scale - 8 items [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Proportion of patients adherent to medication at 3 months after discharge as assessed by the Morisky Medication Adherence Scale - 8 items [ Time Frame: 3 months ]
  2. Proportion of patients readmitted to hospital of any cause at 3 months. [ Time Frame: 3 months ]
  3. Proportion of patients dying of any cause at 3 months. [ Time Frame: 3 months ]
  4. Change in quality of life from baseline assessed with EuroQol questionnaire EQ-5D-3L at 3 months. [ Time Frame: Baseline and 3 months ]
  5. Change in beliefs about medicines from baseline assessed with the Beliefs about Medicines Questionnaire (BMQ) at 3 months. [ Time Frame: Baseline and 3 months ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787941


Contacts
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Contact: Katja Taxis, PhD 0031 50 3638205 k.taxis@rug.nl
Contact: Thang Nguyen, MSc 84 968969129 t.nguyen@rug.nl

Locations
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Netherlands
University of Groningen Recruiting
Groningen, Netherlands, 9713 AV
Contact: Katja Taxis, PhD    0031 50 3638205    k.taxis@rug.nl   
Contact: Thang Nguyen, MSc    84 968969129    t.nguyen@rug.nl   
Sponsors and Collaborators
University of Groningen
Ho Chi Minh City University of Medicine and Pharmacy
Investigators
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Principal Investigator: Katja Taxis, PhD Unit PharmacoTherapy, -Epidemiology & -Economics, Faculty of Mathematics and Natural Sciences, University of Groningen, The Netherlands
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Katja Taxis, Professor of Pharmacotherapy and Pharmaceutical Care, University of Groningen
ClinicalTrials.gov Identifier: NCT02787941    
Other Study ID Numbers: PI-MA-ACS-Vietnam
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Katja Taxis, University of Groningen:
acute coronary syndrome
medication adherence
pharmacist-led interventions
Vietnam
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases