Mi Propio Camino (Finding My Own Way): Personalized Approaches to Improve Blood Pressure Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 511
- 试验地点
- 1
- 主要终点
- Medication Adherence (Objective)
研究概览
简要总结
The purpose of this study is to compare the effect of two educational interventions on adherence to blood pressure medications among adults with uncontrolled hypertension.
详细描述
The study is a randomized controlled trial (RCT) consisting of a 4-session educational intervention (completed over the course of 4-8 weeks) and a 6-month follow-up period for adherence monitoring. Participants will be allocated to one of two educational intervention groups following a block randomization schedule, stratified on the hypothesized mediator variable of medication-related beliefs (high versus low scores on the BMQ Necessity-Concerns subscore) to ensure the groups are balanced on this variable. Primary endpoint is medication adherence at 6 month follow-up, defined as the proportion of days that the prescribed number of doses was taken by the patient during a 30-day period, measured by a pill bottle cap monitor (medication events monitoring device [MEMS]).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •are: (1) age 18 years or greater, (2) uncontrolled hypertension (BP above 140/90 mmHg), (3) Hispanic ethnicity, (4) Spanish or English-speaking, (5) at least one office visit at the study clinic in prior 12 months.
排除标准
- •Persons with stage 4 or 5 chronic kidney disease (CKD) will be excluded.
研究组 & 干预措施
Mi Propio Camino (MPC; My Own Way)
Participants will complete the MPC intervention alongside usual care for hypertension
干预措施: Mi Propio Camino (MPC) (Behavioral)
Habilidades para Controlar la Presion (HCP; Skills for Blood Pressure Control)
Participants will complete the HCP intervention alongside usual care for hypertension.
干预措施: Habilidades para Controlar la Presion (HCP; Skills for Blood Pressure Control) (Behavioral)
结局指标
主要结局
Medication Adherence (Objective)
时间窗: 6 months post-intervention
Medication adherence is assessed at 6-month follow-up with Medication Event Monitoring System (MEMS) pill bottle cap monitors (MWV/WestRock), an objective, gold-standard measure for pill-taking behavior. MEMS caps can be affixed to a medicine bottle to record each time the bottle is opened, indicating when the patient took the medication. Daily adherence is defined as the proportion of days that the prescribed number of doses was taken by the patient during a 30-day period.
次要结局
- Medication Adherence (Subjective)(6 months post-intervention)
- Number of Participants Who Were Nonadherent Due To Beliefs (Subjective)(6 months post-intervention)
- Medication-related Beliefs (Specific)(5 months post-intervention)
- Systolic Blood Pressure(6 months post-intervention)
- Diastolic Blood Pressure(6 months post-intervention)
研究者
John Thomas Billimek
Faculty
University of California, Irvine