Tailored Approaches to Improve Medication Adherence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Feasibility of Retaining Study Participants Through the 3 Month Trial
研究概览
简要总结
The purpose of this study is to to culturally tailor a technology-based individualized adherence intervention for Black and Latino patients with uncontrolled HTN or T2DM, who are non-adherent to their medications, and determine its acceptability.
详细描述
Using a randomized controlled trial design, this study will compare the efficacy of a tailored adherence intervention (TAI) to a single patient education (PE) session, on medication adherence among 40 high-risk Black and Latino patients with uncontrolled hypertension (HTN) who are non-adherent to their prescribed antihypertensive medications. Patients randomized to the PE group will receive a single tablet delivered patient education session at the baseline visit. Patients randomized to the TAI group will complete a tailoring survey at the baseline visit to identify the most salient adherence barriers to the individual, which will be used to create an individualized adherence profile. Following completion of the tailoring survey, patients will collaborate with the RA to identify the most suitable mix of intervention strategies for improving medication adherence (i.e., reminder aids, motivational interviewing, case management) that are matched to the barriers outlined on patients' individualized adherence profiles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (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
- •Have uncontrolled hypertension defined as BP>140/90 mmHg on at least two consecutive visits in the past year (or BP>130/80 mmHg for those with diabetes or kidney disease) and Framingham Risk Scores (FRS) >20% (or at least one CVD risk factor including hyperlipidemia or diabetes);
- •Have been prescribed at least one antihypertensive or oral anti-diabetic medication;
- •Self-identify as Latino or African American/Black
- •Be > 18 years of age
排除标准
- •Refuse or are unable to provide informed consent;
- •Currently participate in another hypertension study; or 2 diabetes study
- •Have significant psychiatric comorbidity
- •Plan to discontinue care at the clinic within the next 3 months
- •Vulnerable populations including adults unable to provide informed consent, pregnant women, and prisoners will be excluded from this study.
研究组 & 干预措施
Attention Control
Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes
干预措施: Attention Control (Other)
Tailored Adherence Intervention
Tablet-based tailored adherence intervention matched to patients' most salient adherence barriers
干预措施: Adherence Intervention (Behavioral)
结局指标
主要结局
Feasibility of Retaining Study Participants Through the 3 Month Trial
时间窗: 3 months
Feasibility is assessed as the absolute number of patients that are retained in the study once they are consented and enrolled at baseline.
次要结局
- Change From Baseline in Mean Systolic and Diastolic Blood Pressure at 3 Months(baseline and 3 months)
- Change From Baseline in Self-reported Medication Adherence at 3 Months(Baseline and 3 months)
- Change From Baseline in HbA1c at 3 Months(baseline and 3 months)