Mobile Health for Alcohol Use Disorders in Clinical Practice

Integrating mHealth for Alcohol Use Disorders Into Clinical Practice

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Drinking; Telemedicine
• Intervention / Treatment: Behavioral: A-CHESS self-monitored; Behavioral: A-CHESS peer-supported; Behavioral: A-CHESS clinically-integrated

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.

• Study Type: Interventional
• Enrollment (Actual): 558
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53718
      • UW Health at the American Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Self monitored; Patients of this group will continue receiving regular care from their physician with no interference from the two experimental groups. Patient subjects will download the app on their Android or Apple smart phone that will direct them to external information hosted on the internet that may help reduce their drinking (e.g., NIAAA resources). For the first 12 weeks, once a week patients can set a weekly goal related to their alcohol use or other health related behaviors (e.g., "I will only drink on Friday this week."). At the end of the week subjects will be prompted to take a weekly survey, which will include questions such as a variation of the brief alcohol monitor (BAM) and timeline followback. Patients will then receive feedback on the amount of drinks they had compared to their goal. Then the patient will set a new goal for the following week. Patients will complete quarterly surveys on the A-CHESS app to assess study outcomes.	Behavioral: A-CHESS self-monitored; Patients have access to a smart phone app that provides information on tips on how to reduce drinking, a drink tracker, a journal, discussion boards, and private messaging with a research team member. Patients set weekly goals related to their drinking, reassess each week, and set a new goal for the upcoming week.
Experimental: Peer supported; Patients will be asked to take the same surveys and have the access to the same information as the self-monitoring group. Patient subjects in this group will have access to discussion boards where they can talk to one another and have the ability to share and see stories of other patients. The only involvement of someone other than patients themselves in the peer-supported group will be by a sponsor (i.e., a dedicated user from the area with a sustained history of successful alcohol reduction). The sponsor will participate in discussion groups and encourage use of the system. Patient-reported feedback will be presented directly to the patient.	Behavioral: A-CHESS peer-supported; Patients have access to a smart phone app that provides information on tips on how to reduce drinking, a drink tracker, a journal, discussion boards, and private messaging with a counselor. Patients set weekly goals related to their drinking, reassess each week, and set a new goal for the upcoming week.
Experimental: Clinically integrated; Patients in the clinically integrated group will receive the same intervention as the peer-supported group aside from three differences: 1) patients have the option to share selected elements of their app data with the University of Wisconsin (UW) Health health coach, 2) the health coach will replace the role of the sponsor in the peer-support group, and 3) patients will have the option to attend an initial 60- to 90-minute and two 30-minute follow-up consultations with the health coach in-person, via phone, or via video chat.	Behavioral: A-CHESS clinically-integrated; Patients have access to a smart phone app that provides information on tips on how to reduce drinking, a drink tracker, a journal, discussion boards, and private messaging with a health coach. Patients set weekly goals related to their drinking, reassess each week, and set a new goal for the upcoming week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Heavy Drinking Days, PHDD	Percentage of self-reported Heavy Drinking Days (HDD: 5 or more standard drinks on any day for men under 65, 4 or more standard drinks for women and men over 65) in the last 7 days	12 months
Quality of Life-Physical Health	The physical health subscale of Patient Reported Outcomes Measurement Information System (PROMIS) Global-10 short form was used to assess the quality of life-physical health (QoL-PH). It consists of 4 questions that assess overall physical health aspect of quality of life. Each question will ask patients to indicate their physical health on a scale of 1 (poor) to 5 (excellent). The raw scores of physical health scores (range: 0 to 20) are converted to T-scores (16.2 to 67.7). Higher scores mean better physical health aspects of quality of life.	12 months
Quality of Life-Mental Health	The mental health subscale of Patient Reported Outcomes Measurement Information System (PROMIS) Global-10 short form was used to assess the quality of life-mental health (QoL-MH). It consists of 4 questions that assess overall mental health aspect of quality of life. Each question will ask patients to indicate their mental health on a scale of 1 (poor) to 5 (excellent). The raw scores of mental health scores (range: 0 to 20) are converted to T-scores (21.2 to 67.6). Higher scores mean better mental health aspects of quality of life.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Who Are Willing to Share Data	Patients in the clinically-integrated arm will have the option to share their data collected by A-CHESS with the health coach. Knowing how many patients are willing to share data about their drinking will allow researchers to make hypotheses about how effective A-CHESS can be in a healthcare setting. We did not collect data for this metric.	12 months
Number of Hospital Nights in the Past 6 Months	Patients will be asked to indicate hospital stay (nights) in the past 6 months. Researchers will include this in the cost-effectiveness analysis.	12 months
Cost of Implementation of Each Intervention Arm in US Dollars	The cost (in US dollars) of the intervention will be calculated to determine cost-effectiveness of the study.	up to 3 years
Score of Alcohol Use Disorders Identification Test (AUDIT) Screening Tool	The Alcohol Use Disorders Identification Test (AUDIT) screening tool was used to assess patient alcohol severity. The screening tool consists of 10 questions with 5 possible answers (scoring 0-4). The sum scores of the 10 items are the scale scores ranging from 0 to 40. Higher scores indicate greater alcohol severity.	12 months
Score of the Diagnostic and Statistical Manual- 5 Alcohol Use Disorder (AUD) Severity	The Diagnostic and Statistical Manual of Mental Disorders 5th edition criteria of alcohol use disorder will be used to assess the patient's alcohol use disorder severity. Each item has a score of 1 for agreement or 0 for disagreement of a statement. The sum score of all 11 items is the scale score (range of 0-11 - higher scores indicate greater severity). The severity of the AUD can also be defined as 1) mild: 2 to 3 symptoms; 2) moderate: 4 to 5 symptoms; 3) severe: 6+ symptoms.	12 months
Score of Relatedness as Assessed by the CHESS Bonding Scale	The study will assess how connected patients feel with others. Greater connectedness is associated with fewer risky drinking days. Patients are asked five Likert-scale questions about their relationships with others, responding on a 1-5 scale from 'Never' to 'Nearly Always.' Mean scores are calculated as scale scores, ranging from 1 to 5. Higher scores indicate greater perceived relatedness with others.	12 months
Score of Competence as Assessed by the Perceived Competence Scale (PCS)	The study will assess patients' perceptions of their ability to control and reduce their drinking in order to meet their alcohol use goals. Patients tend to drink less when they feel more confident in managing their alcohol use. Patients will respond to four questions from the Perceived Competence Scale (PCS) about their confidence in responsibly managing alcohol use in various situations. Responses are on a 1-7 scale, from 'Not at all' to 'Very true.' Mean scores (ranging from 1 to 7) are used as the scale scores, with higher scores indicating greater confidence in controlling or reducing drinking.	12 months
Score of Autonomous Motivation as Assessed by Revised Treatment Self Regulation Questionnaire	The study assesses how motivated patients are by their own goals. Patients typically drink less when they, themselves, want to reduce their alcohol. Patients will be asked 6 questions from the autonomous motivation subscale of the Treatment Self-Regulation Questionnaire (TSRQ) about why they will reduce their alcohol use and can indicate how much they identify with each statement on a 1-5 scale corresponding to "Not true" to "Very true", respectively. The mean scores are the scale scores, ranging from 1 to 5. Higher scores mean more autonomous motivation to control and reduce alcohol use.	12 months
Time of Tula Used	The time that participants spent using Tula will be assessed.	12 months
Number of Setback Status Triggered by A-CHESS	The patient's ability to meet their weekly goal will be assessed. When patients are not on track to meet their weekly goal a setback alert will be triggered.	12 months
Variables Used for Predictive Setback Status	The variables that help predict a setback will be assessed and reported. Knowing the variables for setbacks will help researchers program A-CHESS to better predict when patients are likely to have a setback.	up to 3 years
Number of Response Statuses Addressed	Clinicians and patients will be alerted when the system predicts that they may have a setback. This allows researchers to know how useful patients and health coaches found the alerts.	up to 3 years
Pages Viewed on A-CHESS	The number of pages viewed by patients and health coaches will be assessed know how useful patients found different content.	12 Months
Number of Patient Protection Factors Assessed by a Revised Brief Alcohol Monitor	Patients will take a revised Brief Alcohol Monitor survey weekly that asks patients to indicate whether any of the five protection factors exist (sleep, mood, social interaction, work, and urges to drink). The protective factor score is the sum of the number of protection factor items reported by patients during the study period. The scores of the protective factors were planned to be used in the lapse prediction model. Since the study plan changes and the lapse prediction was not the focus of the study, only descriptive statistics are reported. No additional statistical analysis was conducted. Scores range from 7-35. Lower scores indicate a worse outcome for each factor.	12 months

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Andrew Quanbeck, PhD, University of Wisconsin, Madison

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2020
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): January 22, 2024

Study Registration Dates

• First Submitted: July 3, 2019
• First Submitted That Met QC Criteria: July 3, 2019
• First Posted (Actual): July 8, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: mHealth; implementation; wellness; alcohol drinking
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Alcoholism; Alcohol Drinking
• Other Study ID Numbers: 2019-0337; A532007 (Other Identifier: UW- Madison); R01AA024150 (U.S. NIH Grant/Contract); SMPH/FAMILY MED/RES GRANTS (Other Identifier: UW- Madison); Protocol Version 8/18/2021 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data collected during the trial, after deidentification will be available to researchers for independent verification of study outcomes or to conduct subsequent clinical research, whose proposed use of the data has been approved by an independent review committee identified for this purpose.
• IPD Sharing Time Frame: Beginning 9 months after publication of primary outcomes, and ending 3 years following publication.
• IPD Sharing Access Criteria: Proposals should be directed to PI Andrew Quanbeck at arquanbe@wisc.edu. If approved after review by regulatory counsel, requestors will enter into a formal data sharing agreement. Data will be shared via encrypted single-user file transmission protocol.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No