NCT03190356

Soberlink - MAP Outcomes Study Protocol

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 6 (actual)
• Sponsor: Soberlink Healthcare LLC · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: —

Summary

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.

Detailed description

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.

Conditions

• Alcohol Addiction

Interventions

Type	Name	Description
DEVICE	Soberlink Cellular Device	Soberlink Cellular Device delivers real-time blood alcohol results to people who support individuals in recovery. MAP platform helps monitor and support compliance with discharge plans while providing tools to improve outcomes for behavioral health diagnoses.

Timeline

• Start date: 2017-08-22
• Primary completion: 2018-04-24
• Completion: 2018-04-27
• First posted: 2017-06-16
• Last updated: 2018-05-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study