- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07288502
Adherence to Secondary Prevention Drugs and Influencing Factors After Acute Coronary Syndrome in Patients at a Tertiary Center in Nepal
Adherence to Secondary Prevention Medications and Factors Influencing Adherence, After Acute Coronary Syndrome in Patient Attending a Tertiary Care Centre Of Nepal: A Descriptive Cross-sectional Study
This study aimed to assess adherence to secondary prevention medications among patients in Nepal following an Acute Coronary Syndrome (ACS) event and to identify factors affecting adherence. ACS was a major cause of morbidity and mortality globally and in Nepal, requiring effective secondary prevention to minimize recurrent cardiovascular events. However, adherence to prescribed medications remained low, especially in low- and middle-income countries like Nepal. Poor adherence could lead to increased healthcare burden, worsened patient outcomes, and higher mortality rates. To address this, the study evaluated patients' medication adherence through the MYMEDS questionnaire, a self-reported tool that was positively received for its simplicity and clarity. Conducted at the Manmohan Cardiothoracic Vascular and Transplant Centre in Nepal, the study involved a sample of adult patients who were readmitted or attending follow-ups post-ACS. The research gathered data on patient demographics, socioeconomic factors, clinical characteristics, and self-reported adherence barriers, analyzing these with SPSS to assess correlations with clinical outcomes.
The 12-month project consisted of phases for ethical approvals, data collection, analysis, and report dissemination. By identifying key barriers to adherence, the study aimed to inform targeted interventions that could enhance medication adherence, improve long-term cardiovascular outcomes, and reduce healthcare burdens in Nepal and other similar settings.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Kathmandu, Nepal, 44600
- Manmohan Cardiothoracic Vascular and Transplant Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients diagnosed with ACS, including ST-Elevation Myocardial Infarction (STEMI), Non-ST-Elevation Myocardial Infarction (NSTEMI), or Unstable Angina within the last 12 months
- Patients aged 18 years and older.
- Patients willing to participate and provide informed consent for the study.
Exclusion Criteria:
- Individuals who have not been diagnosed with ACS or those with other acute or chronic conditions that might influence medication adherence unrelated to ACS.
- Patients with cognitive impairments or mental health issues that prevent them from understanding or responding accurately to the study questionnaires.
- Patients with severe chronic conditions (e.g., terminal illness, advanced dementia) that may affect their ability to adhere to medication regimens.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Medication adherence to secondary prevention medications measured using the My Experience of Taking Medicines (MYMEDS) questionnaire
Time Frame: 1 year
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The primary outcome of this study is the level of adherence to prescribed secondary prevention medications among patients with Acute Coronary Syndrome (ACS). Medication adherence will be assessed using the My Experience of Taking Medicines (MYMEDS) questionnaire, a validated self-reported adherence assessment tool developed for patients prescribed secondary prevention medicines after myocardial infarction. Adherence will be specifically evaluated using Section 6 of the MYMEDS questionnaire, which assesses how frequently patients have taken each prescribed secondary prevention medication over the preceding one month. The medications assessed include antiplatelet agents, statins, beta-blockers, and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (ACE inhibitors/ARBs). Responses are recorded on a 5-point Likert scale: All of the time, Nearly all of the time, Most of the time, About half of the time, Less than half of the time. For the purpose of analysis, pat |
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Patient-reported barriers to medication adherence assessed using the My Experience of Taking Medicines (MYMEDS) questionnaire
Time Frame: 1 year
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Secondary outcomes include the identification of patient-reported factors influencing adherence to secondary prevention medications. These factors will be assessed using Sections 2 to 5 of the MYMEDS questionnaire, which evaluate modifiable barriers to medication adherence. These sections assess: Patients' understanding of and satisfaction with prescribed medications Concerns and beliefs regarding potential harms or necessity of medicines Practical difficulties related to medication use (e.g., swallowing pills, opening containers, obtaining refills) Challenges in integrating medications into daily routines, including forgetfulness and inconvenience Responses are measured using a 4-point Likert scale (Strongly agree, Agree, Disagree, Strongly disagree). Higher agreement with barrier-related statements indicates greater perceived barriers to adherence. Results will be summarized as frequencies and proportions for each barrier domain. |
1 year
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Association between medication adherence and demographic and clinical factors
Time Frame: 1 year
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This outcome will assess the association between medication adherence status (adherent vs non-adherent) and patient demographic characteristics (age, sex, education level, occupation, place of residence, income) as well as clinical factors (type of ACS, comorbidities, and treatment received).
This analysis aims to identify population subgroups at higher risk of non-adherence.
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1 year
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Heart Diseases
- Myocardial Ischemia
- Acute Coronary Syndrome
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Surveys and Questionnaires
Other Study ID Numbers
- 290 (6-11) E2 081/ 082
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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