Improving Medication Adherence Through a Health Literacy-based Intervention for Coronary Heart Disease Patients

Study Overview
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Brief Summary
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This is a multi-center pilot study to examine the effectiveness of a health literacy-based intervention to improve medication adherence and self-efficacy of medication use among individuals with coronary heart disease (CHD). The specific aims are to: i) develop a health literacy-based intervention to improve medication adherence for CHD individuals with low health literacy and ii) evaluate the effects of a health literacy-based intervention on improving medication adherence and self-efficacy in CHD individuals.

Detailed Description
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The project will be conducted in 2 phases. Phase 1 is to develop the health literacy-based intervention that consists of a video and an education booklet. Phase 2 is to conduct a pilot study to evaluate the effectiveness of the intervention. A total of 60 participants with low health literacy and diagnosed with CHD will be recruited in two settings. Data will be collected at baseline and 4-weeks after enrollment. The following data will be collected: At baseline: Socio-demographic information (e.g. age, gender, education level, income, past medical history, social support), health literacy (eligibility screening at time of recruitment), CHD knowledge, medication adherence, and medication self-efficacy. 4-weeks after enrollment: medication self-efficacy and medication adherence.

Official Title
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Improving Medication Adherence Through a Health Literacy-based Intervention for Coronary Heart Disease Patients With Low Health Literacy

Conditions
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Coronary Disease

Intervention / Treatment
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* Behavioral: Health literacy-based intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged ≥18 years and diagnosed with CHD. Currently receiving pharmacological therapy such as statins, anti-platelet and/or blood thinner, beta-blockers, calcium channel blockers, nitroglycerin, and angiotensin- converting enzyme inhibitors (ACE). Low health literacy score of 9 or less as measured using the short-form Mandarin Health Literacy Scale (s-MHLS). Exclusion Criteria: History of significant cognitive impairment, psychiatric disorders, and aphasia. Without access to a telephone or unable to give telephone contact. Currently enrolled in another program or clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>At baseline: video and education booklet. 2-weeks after enrollment: telephone call by nurse. | Behavioral: Health literacy-based intervention<br>* Participants in the intervention group will receive a: i) 30-min video about medication adherence, ii) medication adherence booklet, and iii) 2-week telephone call by a nurse.<br>|
| No Intervention: Control group<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline medication adherence at 4-weeks follow-up | Measured using the Chinese version of the Hill-Bone Medication Adherence Scale (HB-MAS). The HB-MAS is a self-reported measure of the extent of medication adherence. The HB-MAS consists of 9 questions with each item rated on a 4-point scale (1 = none of the time; 2 = some of the time; 3 = most of the time; and 4 = all of the time). The total score ranges from 9 (minimum) to 36 (maximum), where lower scores indicate higher levels of medication adherence. | Baseline and 4-weeks follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline medication self-efficacy at 4-weeks follow-up | Measured using the Chinese version of the Self-Efficacy for Appropriate Medication Use (C-SEAMS). The C-SEAMS is a self-reported measure of the extent of confidence in taking medications. The C-SEAMS consists of 13 questions with each item rated on a 3-point scale (1 = not confident; 2 = somewhat confident; 3 = very confident). The total score ranges from 13 (minimum) to 39 (maximum), where higher scores indicate higher levels of self-efficacy for medication use. | Baseline and 4-weeks follow-up |