[试验性设备（未经美国FDA批准或认证）]
[未获得美国食品药品监督管理局批准或许可的设备试验]
研究概览
详细说明
Participation in the study will last 12 months. Participants will be asked to complete assessments at 33 timepoints over the 12-month trial. This will include 1 screening assessment, 24 weekly assessments, 6 monthly assessments, and 2 follow-up assessments. All study assessments will be completed remotely.
Staff at each site will identify potential participants being treated with buprenorphine for opioid use disorder at their respective site. Providers will introduce the study and if interested, the participant will complete a screening assessment conducted by trained study staff to determine eligibility for the study.
Participants who are eligible will be enrolled into the study and given access to the KIOS app.
The active phase will include the first 6 months during which time participants will use the app, complete monthly assessments, and complete a weekly craving assessment. The second 6 months in the study will include two follow-up assessments at 9 months and 12 months post study start. At the end of the 12 months, app access will be removed. The follow up assessments will include the monthly assessments that were completed during the active phase, as well as the craving assessment. All assessments will be sent to the participants' email address for them to complete on any device with internet access. At the conclusion of 12 months of study participation, focus groups will be conducted with 25 of the participants to gather information about their perspectives on the app and its usability and features.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Elise Marino, PhD
- 电话号码：(210) 567-5399
- 邮箱：marinoe@uthscsa.edu
研究联系人备份
- 姓名：McKenna Garcia
- 电话号码：(210) 450-7371
- 邮箱：garciam98@uthscsa.edu
学习地点
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Texas
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San Antonio、Texas、美国、78229
- University of Texas Health Science Center - Department of Psychiatry
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Male or female outpatients 18 years of age or older
- DSM-5 criteria for opioid use disorder
- Ability to access KIOS via smartphone or tablet
- Initiated buprenorphine treatment in the past 6 months
Exclusion Criteria:
- Unwilling or unable to comply with study requirements
- A psychiatric or medical condition interfering with ability to use the app
- Incarceration
- Suicide risk as determined by the treating medical clinician at the site
学习计划
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Treatment as usual and KIOS app
Participants will be set up onto their preferred device(s) with assistance from a research assistant.
KIOS will be accessible on all mobile devices as well as tablets.
Treatment as usual (TAU) will be administered to all participants.
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A digital health therapeutic intended to help individuals in recovery from opioid use disorder better self-manage their condition.
KIOS offers individualized, evidence-based behavioral intervention strategies responsive to the patients' current clinical status outside the setting of the doctor's office or treatment facility.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Retention in treatment
大体时间：Baseline to 1 year
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The number of days from the start of the one-year intervention until the participant either leaves the trial or completes the trial.
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Baseline to 1 year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Diagnostic Statistical Manual Version 5 (DSM-5)
大体时间：Baseline to 12 months
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DSM-5 criteria describe OUD as a pattern of opioid use leading to problems or distress
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Baseline to 12 months
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Opioid Craving Scale
大体时间：Baseline to 12 months
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A brief 3-item measure used to measure opioid craving.
The scale consists of 3 items rated on a visual analog scale from 0-10.
Items are as follows: 1) How much do you currently crave opiates?; 2) In the past week, please rate how strong your desire to use opiates has been when something in the environment has reminded you of opiates?; and 3) Please imagine yourself in the environment in which you previously used opiates.
If you were in this environment today and if it were the time of day that you typically used opiates, what is the likelihood that you would use opiates today.
The total scores range from 3-30 with a higher score indicating more opioid craving.
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Baseline to 12 months
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Patient Health Questionnaire-9 (PHQ-9)
大体时间：Baseline to 12 months
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A self-administered 9-item depression module that scores each of the 9 DSM-V (Diagnostic and Statistical Manual of Mental Disorders, 5th edition).
Items are score 0 to 3, providing a 0 to 27 severity score.
Scores of 5, 10, 15, and 20 represent cutoff points for mild, moderate, moderately severe, and severe depression, respectively.
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Baseline to 12 months
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Generalized Anxiety Disorder-7 (GAD-7)
大体时间：Baseline to 12 months
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The Generalized Anxiety Disorder-7 (GAD-7)13 measures anxiety with 7 items scored from 0 to 3, providing a 0 to 21 severity score.
Scores of 5, 10, and 15 represent cutoff points for mild, moderate, and severe anxiety, espectively.
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Baseline to 12 months
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Treatment Progress and Recovery (TEA)
大体时间：6 to 12 months
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The TEA gauges progress in treatment and recovery within four domains established by prior research: substance use, health (physical or emotional), lifestyle (housing/living situation, family, employment, relationships), and community (obeying laws, responsible member of society).
For each area, the patient is asked to think about how much better things have become on a 10-point scale (1 = not better at all and 10 = very much better).
Scores range between 0-40, with a higher score indicating greater progress in treatment and recovery
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6 to 12 months
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System Usability Scale (SUS)
大体时间：6 months
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The System Usability Scale (SUS)15 is a 10-item measure for assessing a system's usability on a 5-point Likert scale from strongly agree to strongly disagree.
Scores are converted to a 100-point scale.
A score above a 68 would be considered above average usability.
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6 months
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KIOS User Satisfaction Survey
大体时间：6 months
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Participants complete a survey specific to KIOS regarding: (1) the content, appropriateness, and relevance of the advice; (2) enhancement of self-management skills; (3) selfawareness; and (4) overall satisfaction with health.
Survey items will be answered with level of agreement with a given statement recorded on a Likert-type 0 (Disagree) - 7 (Agree) scale.
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6 months
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合作者和调查者
调查人员
- 首席研究员：Elise Marino, PhD、The University of Texas Health Science Center at San Antonio
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.