Soberlink - MAP Outcomes Study Protocol

NCT ID: NCT03190356

Last Updated: 2018-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-22

Study Completion Date

2018-04-27

Brief Summary

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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

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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

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Alcohol Addiction

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Primary diagnosis alcohol use disorder (AUD)

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

Soberlink Cellular Device

Intervention Type 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.

Secondary diagnosis alcohol use disorder (AUD)

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

Soberlink Cellular Device

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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MAP patient engagement platform (EHR)

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MAP Health Management LLC

UNKNOWN

Sponsor Role collaborator

Soberlink Healthcare LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shannon Hanrahan, PhD

Role: PRINCIPAL_INVESTIGATOR

Shannon Hanrahan

Locations

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MAP Health Management LLC

Austin, Texas, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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SLMAPPROT-2017-001

Identifier Type: -

Identifier Source: org_study_id

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