Soberlink - MAP Outcomes Study Protocol

Alcohol Addiction Clinical Trial

Official title:

Soberlink - MAP Outcomes Study Protocol

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03190356
• Other study ID #: SLMAPPROT-2017-001
• Status: Terminated
• Start date: August 22, 2017
• Est. completion date: April 27, 2018

Study information

• Verified date: May 2018
• Source: Soberlink Healthcare LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: April 27, 2018
• Est. primary completion date: April 24, 2018
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Addiction
• Alcoholism

Intervention

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.

Locations

Country	Name	City	State
United States	MAP Health Management LLC	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Soberlink Healthcare LLC	MAP Health Management LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recidivism	Determination of client relapse or risk of relapsing through the use of testing data compiled by the Soberlink Cellular Device	90 days duration of subject participation

External Links

•   American Cancer Society - Alcohol Use and Cancer
•   CDC Ambulatory Health Care Data
•   NIH Overview of Alcohol Consumption Facts