Using mHealth to Aid Opioid Medication Adherence Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- questionnaire assessing usability of the system.
研究概览
简要总结
The purpose of this study is to evaluate the usability of an interactive smartphone application (app) designed to engage and support patients receiving bup/nal.
详细描述
The purpose of this study is to evaluate the usability of a medication management aid for opioid dependence named SubAID. The SubAID system is a smartphone application and medication monitor designed to optimize adherence behaviors of an OD patient responsible for administering bup/nal maintenance therapy medication.
Usability of the SubAID system will be tested utilizing a 3-Stage study design over a 5 week period among a cohort of subjects prescribed bup/nal and undergoing OST.
- Stage 1 - 1 week: Participants will use only an electronic medication monitor (MedSignals) in control mode to passively record baseline adherence to medication.
- Stage 2 - 2 weeks: Participants will use MedSignals in control mode and the smartphone application.
- Stage 3 - 2 weeks: Participants will use MedSignals in active mode and the smartphone application.
After each stage usability assessments will be conducted to evaluate satisfaction with the products from participants.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 21 years of age
- •Physician diagnosis of opioid dependence (OD)
- •Prescribed buprenorphine/naloxone (bup/nal) and acclimated to medication.
- •Able to speak and read English
- •Willing to provide written informed consent prior to study entry
- •Able to understand the study
- •Ownership of an Android or iPhone smartphone
排除标准
- •Having any concurrent medical or psychiatric condition that, in the investigator's opinion, may preclude participation in this study; or
- •Cognitive or other impairment that would interfere with completing a self-administered questionnaire.
结局指标
主要结局
questionnaire assessing usability of the system.
时间窗: up to 5 weeks
次要结局
未报告次要终点