Clinical trial NCT04011644: Mobile Health for Alcohol Use Disorders in Clinical Practice
Official title: Integrating mHealth for Alcohol Use Disorders Into Clinical Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Telemedicine
Keywords: implementation
alcohol drinking
mHealth
wellness
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2019-07-08
Enrollment: 558
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will have rolling enrollment over two years. Patients will be enrolled and randomized to one of three interventions for 12 months.
Primary purpose: TREATMENT

Brief summary: This study evaluates the impact on risky drinking days and quality of life for patients with alcohol use disorder among patients who use a mobile health smart phone application. A third of the participants will receive access to the smart phone app without any monitoring; a third of the participants will receive access to the smart phone app monitored by and connected with a peer mentor; a third will receive access to the smart phone app monitored by and connected with a health coach who works within a healthcare system.

Detailed description: Patients in the trial will be given versions of an evidence-based mobile-health (mHealth) system (re-design based on A-CHESS) that is delivered using different implementation strategies according to study group. A-CHESS has more than 18 services designed to improve social relatedness, coping competence, and intrinsic motivation. The following describes key A-CHESS services that will be tested in the current study:

* Welcome message - patients write why they are choosing to reduce their drinking.
* Coping with Cravings - the system automatically notifies nearby pre-approved friends, family, and peers, who can respond to a request for support. The patient can also be linked to positive activities, such as suggested games to download and play and audio/video-based relaxation recordings.
* Monitoring functionality- self-assessment measures, record of A-CHESS use, and prediction of the patient's likelihood of having a heavy drinking episode in the next week. A-CHESS sends patients with worrisome responses suggestions of coping skills, online peer support, healthy events, etc. With patient permission, a prediction of high-risk can be shared with others in a position to provide support.
* Triage and feedback functionality is designed to derail a setback in goal attainment, giving the patient 'just in time,' tailored support by linking patients to relevant A-CHESS resources or individuals (depending on group assignment).
* The Specialist Report, harvests clinically relevant data from A-CHESS and presents it to a peer mentor (in the peer-supported group) or a health coach (in the clinically integrated group), at which point they may intervene with patients (e.g., through texting in A-CHESS).
* Facilitated discussion groups (in the clinically integrated group.) Discussions are monitored daily by an A-CHESS coach.
* Library - information about healthy lifestyle choices, calendar of healthy events in the area, etc.
* Drink tracker and report feature - patients to self-monitor their drinking and each week see a summary of how they did the past week.
* Profiles about why patients want to reduce their drinking.

All patients enrolled in the study will participate in a 3-month intervention period followed by a 9-month follow-up period, for a total of 12 months. All patient will undergo a 72-hour run-in period. After 72 hours, patients who remain in the study will be randomized to one of the following groups and receive the appropriate access to features. One group will operate independently; one group will have help from a peer-mentor; one group will be connected to a healthcare system by a health coach.

Eligibility criteria: Inclusion Criteria:

* are 21+ years old,
* interested in learning about ways to reduce drinking,
* willing to download and use A-CHESS,
* lives in within the geographical boundaries of the UW Health system
* be able to understand and sign an electronic consent form in English,
* own an Apple or android smart phone,
* meets the criteria for at risk drinking on the AUDIT screening,
* responds yes to at least one question on the Alcohol Use Disorder (AUD) Diagnostic and Statistical Manual-5 survey, and
* indicates in the past week they have had at least 7 drinks and 3 on a single day (women), or had at least 14 drinks and 4 on a single day (men).

Exclusion Criteria:

* has a severe alcohol use disorder (yes to 6+ items on the Alcohol Use Disorder (AUD) Diagnostic and Statistical Manual-5)
* have a current psychotic disorder
* have an acute medical problem requiring immediate hospitalization
* have a known terminal illness

Primary outcomes:
measure: Percentage of Heavy Drinking Days, PHDD
timeFrame: 12 months
measure: Quality of Life-Physical Health
timeFrame: 12 months
measure: Quality of Life-Mental Health
timeFrame: 12 months
Secondary outcomes:
measure: Number of Patients Who Are Willing to Share Data
timeFrame: 12 months
measure: Number of Hospital Nights in the Past 6 Months
timeFrame: 12 months
measure: Cost of Implementation of Each Intervention Arm in US Dollars
timeFrame: up to 3 years
measure: Score of Alcohol Use Disorders Identification Test (AUDIT) Screening Tool
timeFrame: 12 months
measure: Score of the Diagnostic and Statistical Manual- 5 Alcohol Use Disorder (AUD) Severity
timeFrame: 12 months
measure: Score of Relatedness as Assessed by the CHESS Bonding Scale
timeFrame: 12 months
measure: Score of Competence as Assessed by the Perceived Competence Scale (PCS)
timeFrame: 12 months
measure: Score of Autonomous Motivation as Assessed by Revised Treatment Self Regulation Questionnaire
timeFrame: 12 months
measure: Time of Tula Used
timeFrame: 12 months
measure: Number of Setback Status Triggered by A-CHESS
timeFrame: 12 months
measure: Variables Used for Predictive Setback Status
timeFrame: up to 3 years
measure: Number of Response Statuses Addressed
timeFrame: up to 3 years
measure: Pages Viewed on A-CHESS
timeFrame: 12 Months
measure: Number of Patient Protection Factors Assessed by a Revised Brief Alcohol Monitor
timeFrame: 12 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: UW Health at the American Center
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Andrew Quanbeck, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park LS, Chih MY, Stephenson C, Schumacher N, Brown R, Gustafson D, Barrett B, Quanbeck A. Testing an mHealth System for Individuals With Mild to Moderate Alcohol Use Disorders: Protocol for a Type 1 Hybrid Effectiveness-Implementation Trial. JMIR Res Protoc. 2022 Feb 18;11(2):e31109. doi: 10.2196/31109.