Alcohol DrinkingNCT04011644
Mobile Health for Alcohol Use Disorders in Clinical Practice
A study testing A-CHESS self-monitored, A-CHESS peer-supported and A-CHESS clinically-integrated in people with Alcohol Drinking and Telemedicine, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Telemedicine
- What is being tested?
- A-CHESS self-monitored, A-CHESS peer-supported and A-CHESS clinically-integrated
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 558 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2020to 22 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
Show all 9Show fewer
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UW Health at the American Center
Madison, Wisconsin, 53718
About this study
Official title: 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.
Read the 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
- Being tested
- A-CHESS self-monitored, A-CHESS peer-supported, A-CHESS clinically-integrated
- Keywords
- implementation, alcohol drinking, mHealth, wellness
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A-CHESS self-monitoredBehavioural
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.
A-CHESS peer-supportedBehavioural
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.
A-CHESS clinically-integratedBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Self monitored | Active comparator | 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. Receives: Behavioral: A-CHESS self-monitored |
| Peer supported | Experimental | 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. Receives: Behavioral: A-CHESS peer-supported |
| Clinically integrated | Experimental | 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. Receives: Behavioral: A-CHESS clinically-integrated |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 12 months
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Time of Tula Used
The time that participants spent using Tula will be assessed.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start23 Mar 2020
- Primary completion31 Oct 2023
- Study completion22 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 558 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Andrew Quanbeck, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011644
- Sponsor's protocol ID
- 2019-0337
- Other IDs
- R01AA024150, A532007, SMPH/FAMILY MED/RES GRANTS, Protocol Version 8/18/2021
- Status last verified
- Jan 2025
- First submitted
- 3 Jul 2019
- Last updated
- 23 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Jacobson N, Park LS, Pulvermacher A, Voelker S, Herzog M, Quanbeck A. Exploring Fit in a Mobile Health Intervention for Alcohol Use Disorder: Qualitative Study. JMIR Mhealth Uhealth. 2025 Oct 14;13:e65218. doi: 10.2196/65218.
PubMed 41086457Quanbeck 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.
PubMed 39271938Park 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.
PubMed 35179502
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating mHealth for Alcohol Use Disorders Into Clinical Practice
- ClinicalTrials.gov ID
- NCT04011644
- Acronym / sponsor ID
- 2019-0337
- Conditions
- Alcohol Drinking, Telemedicine
- Keywords
- implementation, alcohol drinking, mHealth, wellness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 558 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 23 Mar 2020 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 22 Jan 2024 (actual)
- First posted
- 8 Jul 2019 (actual)
- Results
- Posted 23 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Self monitored | Active comparator | Behavioral: A-CHESS self-monitoredPatients 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. |
| Peer supported | Experimental | Behavioral: A-CHESS peer-supportedPatients 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. |
| Clinically integrated | Experimental | Behavioral: A-CHESS clinically-integratedPatients 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. |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A-CHESS self-monitoredPatients 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. | Behavioural | Self monitored |
| A-CHESS peer-supportedPatients 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. | Behavioural | Peer supported |
| A-CHESS clinically-integratedPatients 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. | Behavioural | Clinically integrated |
Primary outcome
Percentage of Heavy Drinking Days, PHDD
Time frame: 12 months
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
Quality of Life-Physical Health
Time frame: 12 months
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.
Quality of Life-Mental Health
Time frame: 12 months
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.
14 secondary outcomes
Number of Patients Who Are Willing to Share Data
Time frame: 12 months
Number of Hospital Nights in the Past 6 Months
Time frame: 12 months
Cost of Implementation of Each Intervention Arm in US Dollars
Time frame: up to 3 years
Score of Alcohol Use Disorders Identification Test (AUDIT) Screening Tool
Time frame: 12 months
Score of the Diagnostic and Statistical Manual- 5 Alcohol Use Disorder (AUD) Severity
Time frame: 12 months
Score of Relatedness as Assessed by the CHESS Bonding Scale
Time frame: 12 months
Score of Competence as Assessed by the Perceived Competence Scale (PCS)
Time frame: 12 months
Score of Autonomous Motivation as Assessed by Revised Treatment Self Regulation Questionnaire
Time frame: 12 months
Time of Tula Used
Time frame: 12 months
Number of Setback Status Triggered by A-CHESS
Time frame: 12 months
Variables Used for Predictive Setback Status
Time frame: up to 3 years
Number of Response Statuses Addressed
Time frame: up to 3 years
Pages Viewed on A-CHESS
Time frame: 12 Months
Number of Patient Protection Factors Assessed by a Revised Brief Alcohol Monitor
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41086457Jacobson N, Park LS, Pulvermacher A, Voelker S, Herzog M, Quanbeck A. Exploring Fit in a Mobile Health Intervention for Alcohol Use Disorder: Qualitative Study. JMIR Mhealth Uhealth. 2025 Oct 14;13:e65218. doi: 10.2196/65218.
- Derived from this study: PubMed 39271938Quanbeck 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.
- Derived from this study: PubMed 35179502Park 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.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Alcohol Drinking
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
RecruitingPhase 2
Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder
Alcohol Use Disorder
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Quanbeck, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A-CHESS self-monitored, A-CHESS peer-supported and A-CHESS clinically-integrated in people with Alcohol Drinking and Telemedicine, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Heavy Drinking Days, PHDD (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04011644, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.