mHealth for Patient Self-Management of Opioid Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Usability Score
研究概览
简要总结
Twenty individuals diagnosed with opioid use disorder (OUD) will be recruited to participate in a beta test to demonstrate feasibility of using an online tool to help them better self-manage their recovery.
详细描述
Participants will be enrolled in a 4-week single group pre-post evaluation. All participants will attend a two hour orientation to complete baseline assessments, learn how to access and use the software, and participate in a training session. Study participants will be asked to complete assessments online at least three times per week, but no more than once daily. The software may still be accessed by participants as many times as desired to review advice and graphs. After the four week evaluation phase, participants will return for a two hour debriefing and completion of assessment surveys. This approach permits users to be adequately trained while also evaluating the software within their typical environment rather than in a lab setting.
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
- 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;
- •opioid use disorder as assessed by MINI 6.0;
- •currently stable in OUD outpatient treatment for 4 weeks or longer; and
- •ability to access KIOS-OUD via computer, smartphone, or tablet.
排除标准
- •are unwilling or unable to comply with study requirements;
- •have a major untreated psychiatric illness (e.g., schizophrenia, bipolar disorder) or suicidality.
结局指标
主要结局
Usability Score
时间窗: Usability was assessed at end of the study, at 4 weeks
The Systems Usability Scale-Modified, a single-factor, 10-item self-report scale was used to evaluate participants' subjective experience using the 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
- Mean Change on Patient-entered Data From KIOS App(baseline 4-weeks)
- Mean Change in Depression Score From Baseline(This instrument was administered at baseline and at the end of the study (4 weeks))
- Opioid Use(4 weeks)
- Change in World Health Organization Quality of Life Assessment From Baseline(This instrument was issued at baseline and at the end of study (4-weeks))