Soberlink - MAP Outcomes Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Recidivism
研究概览
简要总结
The purpose of this study is to show the effectiveness of Soberlink's remote alcohol monitoring system integrated with MAP's patient engagement platform (EHR) to monitor a sample size of at-risk alcohol use disorder (AUD) population. Ultimately, this data is leveraged to improve clinical outcomes and manage financial risk through facilitating early interventions and other means of mitigating recidivism and costly treatment episodes from AUD population.
详细描述
The study will include 30 Clients with a primary or secondary diagnosis of alcohol use disorder (AUD) and are enrolled in MAP's System where dedicated Case Managers are monitoring the Client's relapse risk levels. Soberlink's remote alcohol system will provide data to inform the Case Manager if the Client has relapsed or is at risk of relapsing through the use of testing data compiled by the Soberlink System. Integrating Soberlink results into MAP's EMR will allow Case Manager to make better clinical decisions and reduce costs by mitigating the chances recidivism through early intervention. Clients will use the Soberlink Device for a period of 90 days.
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 65 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 21-65 years old
- •Subject is active in MAP's program with recovery support services
- •Subject has received acute professional treatment in the last 120 days
- •Primary or secondary diagnosis is Alcohol Use Disorder
- •Subject willing to use Soberlink Device to provide BAC
- •Subject is willing to discuss Soberlink test results with case manager
- •Subject is willing to sign a 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 currently taking anti-alcohol medications
- •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, such as schizophrenia
结局指标
主要结局
Recidivism
时间窗: 90 days duration of subject participation
Determination of client relapse or risk of relapsing through the use of testing data compiled by the Soberlink Cellular Device
次要结局
未报告次要终点