Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-01-03 @ 6:52 AM
Study NCT ID:
NCT03190356
Status:
TERMINATED
Last Update Posted:
2018-05-15
First Post:
2017-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Soberlink - MAP Outcomes Study Protocol
Sponsor:
Soberlink Healthcare LLC
Organization:
Study Overview
Official Title:
Soberlink - MAP Outcomes Study Protocol
Status:
TERMINATED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business Decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: