Soberlink – MAP Outcomes Study Protocol


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Verified June 2017 by Soberlink Healthcare LLC

Sponsor:

Collaborator:

MAP Health Management LLC

Information provided by (Responsible Party):

Soberlink Healthcare LLC

ClinicalTrials.gov Identifier:

NCT03190356

First received: June 14, 2017

Last updated: June 14, 2017

Last verified: June 2017

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.

Alcohol Addiction Device: Soberlink Cellular Device

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Soberlink – MAP Outcomes Study Protocol

Primary Outcome Measures:

Estimated Enrollment: 30
Anticipated Study Start Date: June 15, 2017
Estimated Study Completion Date: November 15, 2017
Estimated Primary Completion Date: November 15, 2017 (Final data collection date for primary outcome measure)
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 Name: 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 Name: MAP patient engagement platform (EHR)

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.

Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample

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.

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 Aetna as their primary insurance provider
  • Subject has received acute professional treatment in the last 60 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03190356

MAP Health Management LLC
Austin, Texas, United States, 78746
Contact: Jacob Levenson    512-524-9277    jacob@thisismap.com   
Contact: Tom Kimball, Ph. D., LMFT    855 627 1010    tom@thisismap.com   

Soberlink Healthcare LLC

MAP Health Management LLC

Principal Investigator: Shannon Hanrahan, PhD Shannon Hanrahan

Additional Information:

Responsible Party: Soberlink Healthcare LLC
ClinicalTrials.gov Identifier: NCT03190356     History of Changes
Other Study ID Numbers: SLMAPPROT-2017-001
Study First Received: June 14, 2017
Last Updated: June 14, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 16, 2017