Soberlink - MAP Outcomes Study Protocol

NCT03190356 | Terminated FDA Device

• 1 other identifier: SLMAPPROT-2017-001
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Addiction

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Primary diagnosis alcohol use disorder (AUD)

Primary diagnosis of alcohol use disorder (AUD) population enrolled in MAP's System

Device: Soberlink Cellular Device

Secondary diagnosis alcohol use disorder (AUD)

Secondary diagnosis of alcohol use disorder (AUD) population enrolled in MAP's System

Device: Soberlink Cellular Device

Interventions

Soberlink Cellular Device 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.

Also known as: MAP patient engagement platform (EHR)

Primary diagnosis alcohol use disorder (AUD); Secondary diagnosis alcohol use disorder (AUD)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Soberlink Healthcare LLC: lead
• MAP Health Management LLC: collaborator

Study Sites (1)

MAP Health Management LLC

Austin, Texas, 78746, United States

Location

Related Links

• American Cancer Society - Alcohol Use and Cancer

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Shannon Hanrahan, PhD

  Shannon Hanrahan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2017
• First Posted: June 16, 2017
• Study Start: August 22, 2017
• Primary Completion: April 24, 2018
• Study Completion: April 27, 2018
• Last Updated: May 15, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)