Improving Medication Adherence Through a Health Literacy-based Intervention for Coronary Heart Disease Patients With Low Health Literacy
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change from baseline medication adherence at 4-weeks follow-up
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Intervention group
At baseline: video and education booklet. 2-weeks after enrollment: telephone call by nurse.
干预措施: Health literacy-based intervention (Behavioral)
Control group
Usual care
结局指标
主要结局
Change from baseline medication adherence at 4-weeks follow-up
时间窗: Baseline and 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.
次要结局
- Change from baseline medication self-efficacy at 4-weeks follow-up(Baseline and 4-weeks follow-up)
研究者
Elaine Siow
Professional Consultant
Chinese University of Hong Kong