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临床试验/NCT03902171
NCT03902171Unknown不适用

Outcomes Related to Use of Soberlink Within In-Home Addiction Treatment Program for Individuals With Alcohol Use Disorder

In-Home Addiction Treatment Institute, Inc.1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年4月2日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
1
主要终点
Rate of Retention in Treatment

研究概览

简要总结

The purpose of this study is to evaluate the impact of use of Soberlink on treatment experience for individuals with alcohol use disorder while enrolled in an In-Home Addiction Treatment program. Treatment engagement, feelings related to autonomy and empowerment, and overall quality of life will be evaluated. Although not the primary focus, recidivism and relapse will be measured.

详细描述

The study will include 30 Clients with a primary or secondary diagnosis of alcohol use disorder (AUD) and who are enrolled in Aware Recovery Care's In-Home Addiction Treatment program where Care Teams will monitor cloud-based breathalyzer results. Soberlink's cloud-based breathalyzer system will provide data to Care Team if the Client has relapsed or is not compliant with testing through the Soberlink System. Clients will use Soberlink for 180 days within context of routine alcohol use disorder treatment at Aware Recovery Care.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
21 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Male or female subject between ages of 21-75 years old
  • •Subject active in In-Home Addiction Treatment Program (Aware Recovery Care)
  • •Subject admitted to program with American Society of Addiction Medicine (ASAM) Assessment score 1.5-2.5
  • •Primary or secondary diagnosis is alcohol use disorder
  • •Subject is willing to use Soberlink Device to provide Blood Alcohol Content (BAC)
  • •Subject is willing to discuss Soberlink test results with Care Team
  • •Subject is willing to sign Soberlink Client Agreement
  • •Subject is English speaking and reading

排除标准

  • •Alcohol use disorder is not a primary or secondary diagnosis
  • •Subject is not between ages of 21 and 75 years old
  • •Subject is currently taking anti-alcohol/craving medications (Antabuse, Campral, Vivitrol)
  • •Subject will not be in the United States through duration of study
  • •Subject is unwilling to properly use the device
  • •Subject is non-English speaking and reading
  • •Subject is a child, adolescent, cognitively impaired, diagnosed with a mental disorder involving depersonalization or active psychotic symptoms
  • •Active withdrawal/alcohol use within 72 hours of start of participation
  • •Subject is using Soberlink data for a child custody or legal consequence

结局指标

主要结局

Rate of Retention in Treatment

时间窗: 180 days duration of subject participation

Participation in In-Home Addiction Treatment program using length of stay reports.

Client Survey Related to use of Soberlink

时间窗: Completed at end of 180 days duration of subject participation

Measures self-report of quality of life and experience with device using 5-point Likert scale (minimum Strongly Disagree, maximum Strongly Agree)

Brief Addiction Monitor questionnaire

时间窗: Conducted monthly throughout 180 days duration of subject participation

Measure change in client report of symptoms related to alcohol use disorder

Positive Outcomes Measures Survey

时间窗: Completed at week 3 or 4 and Week 20 during 180 days duration of subject participation

Measures changes in quality of life using client self-report inquiring about employment, connection to care team, community engagement using yes/no answer key

次要结局

  • Relapse Rates(Measured throughout 180 days duration of subject participation)
  • Hospitalization(Measured throughout 180 days duration of subject participation)
  • Compliance with Testing(Measured throughout 180 days duration of subject participation)
  • Detox and Residential Admissions(Measured throughout 180 days duration of subject participation)

研究者

发起方
In-Home Addiction Treatment Institute, Inc.
申办方类型
Other
责任方
Sponsor

研究点 (1)

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