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临床试验/NCT07348796
NCT07348796尚未招募不适用

Real World Evaluation of the Effectiveness and Implementation of a Digital Health Therapeutic for Opioid Use Disorder (OUD)

The University of Texas Health Science Center at San Antonio1 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2026年8月17日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
134
试验地点
1

研究概览

简要总结

The researchers will study the KIOS app, a digital health tool made to help people recovering from opioid addiction take better care of themselves. They want to see how the app works in real life and learn who benefits most from using it. The study will also ask participants what they think about the app and how easy it is to use.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
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

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Treatment as usual and KIOS app

Experimental

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.

干预措施: KIOS App (Device)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elise Marino

Assistant Professor

The University of Texas Health Science Center at San Antonio

研究点 (1)

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