Soberlink - MAP Outcomes Study Protocol

Terminated

• Conditions: Alcohol Addiction

• Registration Number: NCT03190356
• Lead Sponsor: Soberlink Healthcare LLC

Brief 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.

Study Timeline

• Study First Submitted: 2017-06-14
• Study First Submitted QC: 2017-06-14
• Study First Posted: 2017-06-16
• Study Start: 2017-08-22
• Primary Completion: 2018-04-24
• Study Completion: 2018-04-27
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-09
• Last Update Posted: 2018-05-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recidivism	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

Trial Locations

Locations (1)

MAP Health Management LLC; 🇺🇸 Austin, Texas, United States