Mobile Health for Alcohol Use Disorders in Clinical Practice

NCT ID: NCT04011644

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 558 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-23
• Study Completion Date: 2024-01-22

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.

Conditions

Alcohol Drinking; Telemedicine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

A-CHESS self-monitored

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

A-CHESS peer-supported

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

A-CHESS clinically-integrated

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Quanbeck, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

UW Health at the American Center

Madison, Wisconsin, United States

Countries

United States

References

Quanbeck A, Chih MY, Park L, Li X, Xie Q, Pulvermacher A, Voelker S, Lundwall R, Eby K, Barrett B, Brown R. A randomized trial testing digital medicine support models for mild-to-moderate alcohol use disorder. NPJ Digit Med. 2024 Sep 14;7(1):248. doi: 10.1038/s41746-024-01241-2.

Reference Type: DERIVED

PMID: 39271938 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35179502 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R01AA024150

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A532007

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/FAMILY MED/RES GRANTS

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 8/18/2021

Identifier Type: OTHER

Identifier Source: secondary_id

2019-0337

Identifier Type: -

Identifier Source: org_study_id