Informational App Development for mHealth for Patient Self-Management of Opioid Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Usability Score
研究概览
简要总结
This study will evaluate the feasibility of an app that provides drug information to people in recovery from opioid use disorder. This study is designed to test the prototype app, not to determine health outcomes. The study will confirm the design and operating specifications prior to being evaluated in a larger clinical trial.
详细描述
The overall study is designed in two steps: 1) a one-week proof-of-concept study; and 2) a one-month pilot study.
Step 1: A one-week proof-of-concept study will be performed in a small population (n=5) of individuals in opioid use disorder recovery as an indicator of the app's suitability. Study participants will use the sham app for one week and will then complete a usability and user satisfaction survey. If the app is found to be exhibit acceptable usability and satisfaction, a one month study will be completed in a larger sample (see Step 2, below). If not, modifications to the app will be made and the one-week study will be repeated in a new group of participants.
Step 2: After completion of the proof-of-concept study, 20 new participants will be enrolled in a 4-week trial. Study participants will complete baseline assessments and then be asked to use the app at least three times per week, for four weeks. At the end of four weeks, participants will complete usability and user satisfaction surveys.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Male or female outpatients 18 years of age or older
- •Currently enrolled in an opioid treatment program and receiving medication assisted treatment for opioid use disorder
- •Currently stable in opioid use disorder outpatient treatment for 4 weeks or longer
- •Ability to access the app via smart phone, or tablet.
排除标准
- •Unwilling or unable to comply with study requirements
- •Have a psychiatric or medical disorder interfering with ability to use the app
- •Incarcerated
结局指标
主要结局
Usability Score
时间窗: The Systems Usability Scale will be administered at the end of one-week for participants enrolled in Step 1 of the study and at the end of four-weeks for participants enrolled in Step 2.
The Systems Usability Scale-Modified is a non-health outcome, single-factor, 10-item self-report scale commonly used to evaluate participants' subjective experience using software. Systems Usability Scale yields a single number representing a composite measure of the overall usability of the system being studied. Systems Usability Scale scores have a range of 0 to 100, with higher scores representing a better outcome. Systems in early development may expect to have a rating of 30, while more mature systems should rate between 60 - 80.
次要结局
- User Satisfaction(A user satisfaction survey will be administered at the end of one-week for participants enrolled in Step 1 of the study and at the end of four-weeks for participants enrolled in Step 2.)