Ignite Creation Date:
2024-05-06 @ 8:39 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02787941
Status:
UNKNOWN
Last Update Posted:
2016-06-01
First Post:
2016-05-23
Brief Title:
Pharmacist-led Intervention to Enhance Medication Adherence in Post-acute Coronary Syndrome Patients in Vietnam
Sponsor:
University of Groningen
Organization:
University of Groningen
Study Overview
Official Title:
Pharmacist-delivered Multifaceted Intervention to Enhance Medication Adherence Among Post-acute Coronary Syndrome Patients in Vietnam A Randomised Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2016-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Ischemic heart disease including acute coronary syndrome is among the leading causes of death worldwide Several factors have been shown to attribute to early re-admission to hospital for these conditions including comorbidities insufficient discharge planning lack of health literacy and non-adherence to drug therapy 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 in Vietnam
The study will be designed as a randomised controlled trial with blinded outcome assessors Random allocation sequence will be generated using the website randomizationcom The participants will be stratified by age 65 and 65 years or higher and sex male and female and randomised into two parallel groups in a 11 ratio via block technique with random permuted blocks of 2 4 or 6 patients Investigators who perform patient recruitment and interventions will be concealed the sequence until the intervention is assigned One group will receive usual care called control group while the parallel group will receive pharmacist-delivered multifaceted intervention in addition to usual care called intervention group
Participants will be selected from patients who present to the Cardiology Institute at Ho Chi Minh city Vietnam The trial will continue till achievement of sample size and 3-month follow-up thereafter Estimated duration of recruitment is about 12 months from November 2015 to November 2016 The investigators will include patients who survive during hospitalisation with discharge diagnosis of acute coronary syndrome
The intervention group will receive two counselling sessions in-person and via telephone within 1 week before and after hospital discharge The interventions will be performed by pharmacists and include 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 assessed by the Morisky Medication Adherence Scale - 8 items Secondary outcome measures are the proportions of patients 1 adherent to medication at 3 months after discharge assessed by the Morisky Medication Adherence Scale - 8 items 2 readmitted to hospital and 3 dying within 3 months after discharge The investigators also measure 4 the change in quality of life assessed by the EuroQol EQ-5D-3L and 5 beliefs about medicines assessed by the Beliefs about Medicines Questionnaire BMQ from baseline at 3 months
The process of data collection and management at baseline and during follow-up period is summarised in 9 steps as follows 1 patient list review 2 patient recruitment 3 first data collection at baseline data from patient interviews 4 random allocation 5 first counselling intervention group only 6 second data collection at baseline data from medical records 7 second counselling intervention group only 8 first outcome measurement at 1 month after discharge 9 second outcome measurement at 3 months after discharge
Analysis will be performed using the intention to treat principle Reasons for dropouts and proportions for each treatment group will be reported The investigators will compare the differences in proportions of medication adherence and rates of mortality and hospital readmission between intervention and control groups
All patients taking part in the trial will be required to provide written informed consent at the time of recruitment Consent form and the study protocol will be submitted to achieve approval from the Institutional Biomedical Research Ethics Committee of Cardiology Institute at Ho Chi Minh city Vietnam The participants will have the right to withdraw at any moment during the study period their inclusion or exclusion from the study will not affect the usual care provided to them
The study will be designed as a randomised controlled trial with blinded outcome assessors Random allocation sequence will be generated using the website randomizationcom The participants will be stratified by age 65 and 65 years or higher and sex male and female and randomised into two parallel groups in a 11 ratio via block technique with random permuted blocks of 2 4 or 6 patients Investigators who perform patient recruitment and interventions will be concealed the sequence until the intervention is assigned One group will receive usual care called control group while the parallel group will receive pharmacist-delivered multifaceted intervention in addition to usual care called intervention group
Participants will be selected from patients who present to the Cardiology Institute at Ho Chi Minh city Vietnam The trial will continue till achievement of sample size and 3-month follow-up thereafter Estimated duration of recruitment is about 12 months from November 2015 to November 2016 The investigators will include patients who survive during hospitalisation with discharge diagnosis of acute coronary syndrome
The intervention group will receive two counselling sessions in-person and via telephone within 1 week before and after hospital discharge The interventions will be performed by pharmacists and include 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 assessed by the Morisky Medication Adherence Scale - 8 items Secondary outcome measures are the proportions of patients 1 adherent to medication at 3 months after discharge assessed by the Morisky Medication Adherence Scale - 8 items 2 readmitted to hospital and 3 dying within 3 months after discharge The investigators also measure 4 the change in quality of life assessed by the EuroQol EQ-5D-3L and 5 beliefs about medicines assessed by the Beliefs about Medicines Questionnaire BMQ from baseline at 3 months
The process of data collection and management at baseline and during follow-up period is summarised in 9 steps as follows 1 patient list review 2 patient recruitment 3 first data collection at baseline data from patient interviews 4 random allocation 5 first counselling intervention group only 6 second data collection at baseline data from medical records 7 second counselling intervention group only 8 first outcome measurement at 1 month after discharge 9 second outcome measurement at 3 months after discharge
Analysis will be performed using the intention to treat principle Reasons for dropouts and proportions for each treatment group will be reported The investigators will compare the differences in proportions of medication adherence and rates of mortality and hospital readmission between intervention and control groups
All patients taking part in the trial will be required to provide written informed consent at the time of recruitment Consent form and the study protocol will be submitted to achieve approval from the Institutional Biomedical Research Ethics Committee of Cardiology Institute at Ho Chi Minh city Vietnam The participants will have the right to withdraw at any moment during the study period their inclusion or exclusion from the study will not affect the usual care provided to them
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None