Feasibility of Interventions Impacting Medication Adherence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Medication Event Monitoring System (MEMS) Cap
研究概览
简要总结
Current medication adherence interventions are minimally effective, which results in higher rates of morbidity and mortality for 45 million US adults who have hypertension and low adherence. This feasibility randomized controlled trial seeks to understand the efficacy of reminders and monitoring in the form of a mobile phone application vs usual care on medication adherence as well as the feasibility of the intervention and study procedures. This study will compare participants who use a mobile phone app that notifies them when to take their medications (intervention group) to participants who do not get assigned the app (control group) for 30 days. Medication adherence will be monitored using a Medication Event Monitoring System (MEMS) cap. Both groups will also receive the usual care, which will include giving participants a pamphlet about taking their medications. The long-term goal of this work is to improve antihypertensive medication adherence and to decrease morbidity and mortality. The objective of this application is to test the efficacy of the app based reminders and feedback. The hypothesis driving this research is that the intervention will be more effective than the usual care. The specific aims are as follows:
详细描述
Current medication adherence interventions are minimally effective, which results in higher rates of morbidity and mortality for 45 million US adults who have hypertension and low adherence. This feasibility randomized controlled trial seeks to understand the efficacy of reminders and monitoring in the form of a mobile phone application vs usual care on medication adherence as well as the feasibility of the intervention and study procedures. This study will compare participants who use a mobile phone app that notifies them when to take their medications (intervention group) to participants who do not get assigned the app (control group) for 30 days. Participants will receive an electronic monitoring cap (i.e. a Medication Event Monitoring System (MEMS) cap) to monitor when they take their antihypertensive medications while they are in the study. Both groups will also receive the usual care, which will include giving participants a pamphlet about taking their medications. The long-term goal of this work is to improve antihypertensive medication adherence and to decrease morbidity and mortality. The objective of this application is to test the efficacy of the app based reminders and feedback. The hypothesis driving this research is that the intervention will be more effective than the usual care. The specific aims are as follows:
Aim 1. Compare the efficacy of the app based reminders and feedback with usual care for the primary outcome of medication adherence in 40 adults with hypertension and low adherence.
Aim 2. Conduct a robust process evaluation to guide intervention improvements, dissemination, and implementation in a diverse sample.
The hypothesis will be tested for two specific aims in 40 adults (20 control, 20 intervention) with hypertension and low adherence. For these aims, the study will be conducted as a phase II single-blind, parallel-group, randomized controlled trial with diverse adults with hypertension over 30 days. Participants will answer surveys about their demographics, knowledge about hypertension, and their medication adherence. They will then be randomized and either be given the standard of care or standard of care plus the intervention (app-based reminders and feedback). The intervention includes a brief training session on downloading and using the medication reminder app. Across arms, Participants will track their medication adherence for 30 days using the MEMS cap. After the 30 days, participants will take surveys about their adherence and knowledge about hypertension and have a brief exit interview with a member of the research team to talk about their experience and debrief them about the study.
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
- Single (Participant)
盲法说明
The recruitment material and informed consent will make it appear that the effectiveness between an electronic medication cap and a medication adherence app are being compared and that some participants will get the app while others will get the electronic medication bottle. The reality is that all participants will receive an electronic medication bottle.
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
- •currently be prescribed an antihypertensive medication by their doctor
- •have taken antihypertensive medication for the last year
- •be willing to download and use a new app on their phone for the study
- •score a 34 or lower on the Hill Bone compliance scale
排除标准
- •need assistance taking their medications
- •have a severe cognitive impairment
- •have a severe visual impairment that prevents them from reading notifications on their phone
- •use a pillbox to take their medications
- •do not use a smart phone or their smart phone does not meet the requirements for the app to be downloaded
结局指标
主要结局
Medication Event Monitoring System (MEMS) Cap
时间窗: 30 days
The Medication Event Monitoring System (MEMS) measures medication adherence over 30 days at home. In this system, an electronic cap will be placed on a bottle assigned to the participant's antihypertensive medication and records each time the medication bottle is opened. All participants will use the electronic monitoring for one antihypertensive medication taken daily.
Exit interview
时间窗: 30 days
In the exit interview, participants will be asked qualitative questions about their experiences in the study and using the MEMS cap and medication reminder app. This will support a robust process evaluation to guide intervention improvements, dissemination, and implementation in a diverse sample.
次要结局
未报告次要终点