Soberlink - MAP Outcomes Study Protocol

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.

Study Overview

• Status: Terminated
• Conditions: Alcohol Addiction
• Intervention / Treatment: Device: Soberlink Cellular Device

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 Type: Observational
• Enrollment (Actual): 6

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78746
      • MAP Health Management LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

30 adult male/female 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Primary diagnosis alcohol use disorder (AUD); Primary diagnosis of alcohol use disorder (AUD) population enrolled in MAP's System	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.; Other Names: MAP patient engagement platform (EHR)
Secondary diagnosis alcohol use disorder (AUD); Secondary diagnosis of alcohol use disorder (AUD) population enrolled in MAP's System	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.; Other Names: MAP patient engagement platform (EHR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Soberlink Healthcare LLC
• Collaborators: MAP Health Management LLC
• Investigators: Principal Investigator: Shannon Hanrahan, PhD, Shannon Hanrahan

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2017
• Primary Completion (Actual): April 24, 2018
• Study Completion (Actual): April 27, 2018

Study Registration Dates

• First Submitted: June 14, 2017
• First Submitted That Met QC Criteria: June 14, 2017
• First Posted (Actual): June 16, 2017

Study Record Updates

• Last Update Posted (Actual): May 15, 2018
• Last Update Submitted That Met QC Criteria: May 9, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism
• Other Study ID Numbers: SLMAPPROT-2017-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No