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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA024150 | U.S. NIH Grant/Contract | View source | |
| A532007 | Other Identifier | UW Madison | |
| SMPH/FAMILY MED/RES GRANTS | Other Identifier | UW Madison | |
| Protocol Version 8/18/2021 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A-CHESS self-monitored | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Quanbeck, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UW Health at the American Center | Madison | Wisconsin | 53718 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39271938 | Derived | 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. | |
| 35179502 | Derived | 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. |
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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.
Beginning 9 months after publication of primary outcomes, and ending 3 years following publication.
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.
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The site staff were not enrolled in the clinical trial that is represented in the overall study flow diagram above and as such are not included in it. They were engaged in a post hoc interview to understand the study results for an exploratory analysis.
A three-pronged recruitment strategy encompassing clinical settings, community-based organizations, and public media was used. Clinical study champions, including primary care providers, behavioral health specialists, etc., provided information to potentially eligible patients. Leaders from underrepresented communities promoted the study to their respective diverse populations. Lastly, targeted digital, television, and print media promoted the study broadly.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. 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. |
| FG002 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | percentage of heavy drinking days | 12 months |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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Use of convenience sampling may limit generalizability to other populations; The study did not include a pure control group since doing so would require a "sham device," which was deemed impractical; The study took place during the COVID pandemic, where drinking rates increased nationwide including in Wisconsin.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrew Quanbeck | Dept of Family Medicine and Community Health, UW-Madison | 608-609-7308 | andrew.quanbeck@fammed.wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 13, 2023 | Oct 31, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 9, 2020 | Dec 19, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
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The study will have rolling enrollment over two years. Patients will be enrolled and randomized to one of three interventions for 12 months.
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|
|
| A-CHESS peer-supported | 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. |
|
| A-CHESS clinically-integrated | 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. |
|
| 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 |
| BG001 | 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. 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. |
| BG002 | 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. 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. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
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| AUDIT Category | Count of Participants | Participants |
|
| Percentage of heavy drinking days (PHDD) | One participant in the Clinically Integrated group did not submit baseline measures for PHDD, QOL-PH, and QOL-MH, so the sample size for this group and these outcomes was 186, not the original number, 187. In the baseline and follow-up surveys, the participants were asked to report the number of risky drinking days in the last 7 days. The Percentage of Heavy Drinking Days (PHDD) was calculated by dividing the number of reported risking drinking days by 7. | One participant in the Clinically Integrated group did not submit baseline measures for PHDD, QOL-PH, and QOL-MH, so the sample size for this group and these outcomes was 186, not the original number, 187. | Mean | Standard Deviation | percentage |
|
| Quality of life-physical health, QOL-PH | The Quality-of-Life Physical Health (QoL-PH) was measured using the four global physical health survey items in the Patient-Reported Outcome Measurement Information System (PROMIS) global health short form (SF10 ver.1.2). The raw scores for physical health (range: 4 to 20) were converted to T-scores (range: 16.2 to 67.7) using the PROMIS scoring manual (p.16). T-scores reported here are standardized scores that can be compared to the US general population and have a mean QOL score of 50 with a standard deviation of 10. Higher scores mean better physical health. | One participant in the Clinically Integrated group did not submit baseline measures for PHDD, QOL-PH, and QOL-MH, so the sample size for this group and these outcomes was 186, not the original number, 187. | Mean | Standard Deviation | T-score |
|
| Quality of life-mental health, QOL-MH | The Quality-of-Life Mental Health (QoL-MH) was measured using the four global mental health survey items in the Patient-Reported Outcome Measurement Information System (PROMIS) global health short form (SF10 ver.1.2). The raw scores for mental health (range: 4 to 20) were converted to T-scores (range: 21.2 to 67.6) using the PROMIS scoring manual (p.16). T-scores reported here are standardized scores that can be compared to the US general population and have a mean QOL score of 50 with a standard deviation of 10. Higher scores mean better mental health. | One participant in the Clinically Integrated group did not submit baseline measures for PHDD, QOL-PH, and QOL-MH, so the sample size for this group and these outcomes was 186, not the original number, 187. | Mean | Standard Deviation | T-scores |
|
| OG001 | 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. 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. |
| OG002 | 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. 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. |
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| Primary | 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. | Posted | Mean | Standard Deviation | T-Scores | 12 months |
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| Primary | 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. | Posted | Mean | Standard Deviation | T-Scores | 12 months |
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| Secondary | 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. | We did not collect data for this metric. | Posted | 12 months |
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | Hospital nights | 12 months |
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| Secondary | 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. | Cost reflects total number enrolled, not number completed, to account for program being at full capacity. | Posted | Number | dollars | up to 3 years |
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| Secondary | 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. | Posted | Mean | Standard Deviation | Scores on a scale | 12 months |
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| Secondary | 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. | Posted | Mean | Standard Deviation | Scores on a scale | 12 months |
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| Secondary | 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. | Posted | Mean | Standard Deviation | Scores | 12 months |
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| Secondary | 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. | Posted | Mean | Standard Deviation | Scores | 12 months |
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| Secondary | 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. | Posted | Mean | Standard Deviation | Scores | 12 months |
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| Secondary | Time of Tula Used | The time that participants spent using Tula will be assessed. | Posted | Mean | Standard Deviation | Seconds | 12 months |
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| Secondary | 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. | We did not implement this setback alert so no data are collected for this measure. | Posted | 12 months |
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| Secondary | 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. | We did not implement this setback alert so no data are collected for this measure. | Posted | up to 3 years |
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| Secondary | 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. | We did not implement this setback alert so no data are collected for this measure. | Posted | up to 3 years |
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| Secondary | 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. | Posted | Mean | Standard Deviation | Page view counts | 12 Months |
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| Secondary | 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. | Posted | Mean | Standard Deviation | Score on a scale | 12 months |
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| 0 |
| 185 |
| 0 |
| 185 |
| 0 |
| 185 |
| EG001 | 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. 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. | 0 | 186 | 0 | 186 | 0 | 186 |
| EG002 | 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. 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. | 0 | 187 | 0 | 187 | 0 | 187 |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
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| Unknown or Not Reported |
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| HS or GED |
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| Vocation or associate |
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| Bachelors |
|
| Masters |
|
| Doctorate |
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| Harmful drinking |
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| Alcohol dependence |
|