Soberlink Within In-Home Addiction Treatment Program

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the impact of use of Soberlink on treatment experience for individuals with alcohol use disorder while enrolled in an In-Home Addiction Treatment program. Treatment engagement, feelings related to autonomy and empowerment, and overall quality of life will be evaluated. Although not the primary focus, recidivism and relapse will be measured.

Detailed Description
-----------------
The study will include 30 Clients with a primary or secondary diagnosis of alcohol use disorder (AUD) and who are enrolled in Aware Recovery Care's In-Home Addiction Treatment program where Care Teams will monitor cloud-based breathalyzer results. Soberlink's cloud-based breathalyzer system will provide data to Care Team if the Client has relapsed or is not compliant with testing through the Soberlink System. Clients will use Soberlink for 180 days within context of routine alcohol use disorder treatment at Aware Recovery Care.

Official Title
-----------------
Outcomes Related to Use of Soberlink Within In-Home Addiction Treatment Program for Individuals With Alcohol Use Disorder

Conditions
-----------------
Alcohol Use Disorder

Intervention / Treatment
-----------------
* Device: Soberlink


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subject between ages of 21-75 years old Subject active in In-Home Addiction Treatment Program (Aware Recovery Care) Subject admitted to program with American Society of Addiction Medicine (ASAM) Assessment score 1.5-2.5 Primary or secondary diagnosis is alcohol use disorder Subject is willing to use Soberlink Device to provide Blood Alcohol Content (BAC) Subject is willing to discuss Soberlink test results with Care Team Subject is willing to sign Soberlink Client Agreement Subject is English speaking and reading Exclusion Criteria: Alcohol use disorder is not a primary or secondary diagnosis Subject is not between ages of 21 and 75 years old Subject is currently taking anti-alcohol/craving medications (Antabuse, Campral, Vivitrol) 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 involving depersonalization or active psychotic symptoms Active withdrawal/alcohol use within 72 hours of start of participation Subject is using Soberlink data for a child custody or legal consequence

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary diagnosis alcohol use disorder (AUD)<br>Primary diagnosis of alcohol use disorder (AUD) population enrolled in In-Home Addiction Treatment Program. | Device: Soberlink<br>* Soberlink delivers real-time blood alcohol results to people who support individuals in recovery from alcohol use disorder. In-Home Addiction Treatment program Care Team monitors and responds to results as part of care to improve treatment outcomes.<br>|
| Secondary diagnosis alcohol use disorder (AUD)<br>Secondary diagnosis of alcohol use disorder (AUD) population enrolled in In-Home Addiction Treatment Program. | Device: Soberlink<br>* Soberlink delivers real-time blood alcohol results to people who support individuals in recovery from alcohol use disorder. In-Home Addiction Treatment program Care Team monitors and responds to results as part of care to improve treatment outcomes.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Retention in Treatment | Participation in In-Home Addiction Treatment program using length of stay reports. | 180 days duration of subject participation | 
| Brief Addiction Monitor questionnaire | Measure change in client report of symptoms related to alcohol use disorder | Conducted monthly throughout 180 days duration of subject participation | 
| Positive Outcomes Measures Survey | Measures changes in quality of life using client self-report inquiring about employment, connection to care team, community engagement using yes/no answer key | Completed at week 3 or 4 and Week 20 during 180 days duration of subject participation | 
| Client Survey Related to use of Soberlink | Measures self-report of quality of life and experience with device using 5-point Likert scale (minimum Strongly Disagree, maximum Strongly Agree) | Completed at end of 180 days duration of subject participation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse Rates | Occurrence of alcohol use | Measured throughout 180 days duration of subject participation | 
| Compliance with Testing | Occurrence of Missed Tests | Measured throughout 180 days duration of subject participation | 
| Hospitalization | Occurrence of Emergency Room and Inpatient hospital admissions | Measured throughout 180 days duration of subject participation | 
| Detox and Residential Admissions | Occurrence of residential treatment and detox admissions | Measured throughout 180 days duration of subject participation |