Clinical trial NCT03190356: Soberlink - MAP Outcomes Study Protocol
Official title: Soberlink - MAP Outcomes Study Protocol
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Alcohol Addiction
Lead sponsor: Soberlink Healthcare LLC
Sponsor class: INDUSTRY
Collaborators: name: MAP Health Management LLC
First posted: 2017-06-16
Enrollment: 6
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recidivism
timeFrame: 90 days duration of subject participation
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: MAP Health Management LLC
state: Texas
Study officials:
affiliation: Shannon Hanrahan
name: Shannon Hanrahan, PhD
role: PRINCIPAL_INVESTIGATOR
References: