Evaluation of KIOS in a 12-week Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Retention in treatment
研究概览
简要总结
Evaluation of a mobile medical app (KIOS) vs. treatment as usual for the treatment of opioid use disorder (OUD).
详细描述
The study is a parallel intervention examining the KIOS app, a digital health therapeutic intended to help individuals in recovery from opioid use disorder better self-manage their condition. KIOS will offer individualized, evidence-based behavioral intervention strategies responsive to the patients' current clinical status outside the setting of the doctor's office or treatment facility. KIOS makes it possible to process patient-entered data and provide responsive behavioral advice to patients specific to their condition in real time. KIOS gives patients 24/7 access to behavioral intervention strategies that can augment and improve response to routine clinic-based counseling interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Randomization will be stratified by two characteristics: (1) history of MOUD and (2) stimulant use in past one month. Allocation to treatment groups will be randomly assigned by 1:1 allotment to either KIOS + TAU (treatment as usual) or KIOS sham + TAU with strata. Study staff will be blind to the condition to which the participant is assigned.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female outpatients 18 years of age or older
- •Patients must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
- •DSM-5 (Diagnostic and Statistical Manual of Mental Disorders fifth edition) criteria for opioid use disorder
- •Ability to access KIOS via smartphone or tablet
- •Recently (less than 6 months) enrolled in and currently participating in MOUD at a clinic in Texas
排除标准
- •Unwilling or unable to comply with study requirements
- •Psychiatric or medical disorder interfering with ability to use the app
- •Incarceration
研究组 & 干预措施
Treatment as Usual plus KIOS education App
Treatment as usual in clinics with the use of the KIOs education App (Sham)
干预措施: KIOS App education (Behavioral)
Active Treatment as Usual plus KIOS App
Treatment as usual in clinics with the use of the KIOS App
干预措施: KIOS App (Device)
Treatment as Usual plus KIOS education App
Treatment as usual in clinics with the use of the KIOs education App (Sham)
干预措施: Treatment as usual (Behavioral)
Active Treatment as Usual plus KIOS App
Treatment as usual in clinics with the use of the KIOS App
干预措施: Treatment as usual (Behavioral)
结局指标
主要结局
Retention in treatment
时间窗: Baseline to 13 weeks
Measured by the number of days from the start of the 13-week intervention until the participant either leaves the trial, or completes the trial
次要结局
- Measure of opioid use reduction(60 days to 13 weeks)
- Percentage of Opioid Abstinent Days(Baseline to 13 weeks)
- Completion of treatment(Baseline to 13 weeks)
- Patient Health Questionnaire-9 (PHQ-9)(Baseline and 13 weeks)
- Treatment Effectiveness Assessment TEA)(Baseline and 13 weeks)