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Soberlink - MAP Outcomes Study Protocol

S

Soberlink Healthcare

Status

Terminated

Conditions

Alcohol Addiction

Treatments

Device: Soberlink Cellular Device

Study type

Observational

Funder types

Industry
Other

Identifiers

NCT03190356
SLMAPPROT-2017-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 patients

Sex

All

Ages

21 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

6 participants in 2 patient groups

Primary diagnosis alcohol use disorder (AUD)
Description:
Primary diagnosis of alcohol use disorder (AUD) population enrolled in MAP's System
Treatment:
Device: Soberlink Cellular Device
Secondary diagnosis alcohol use disorder (AUD)
Description:
Secondary diagnosis of alcohol use disorder (AUD) population enrolled in MAP's System
Treatment:
Device: Soberlink Cellular Device

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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