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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23AA026333-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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The purpose of the study is to determine if providing participants with alcohol-related liver disease with tailored alcohol use treatment options is feasible and acceptable in order to increase their engagement with treatment and reduce alcohol use. This is an important area to study to help create ways to increase participants' knowledge about different treatment options as well as increase likelihood of seeking and participating in alcohol use disorder treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MAIN-ART Behavior Tool | Experimental | The Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Tool (MAIN-ART) behavioral intervention is an online web application with two modules: misconception correction and tailored, preference-sensitive alcohol use disorder (AUD) treatment matching. |
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| Routine care | No Intervention | Patients randomized to usual care will receive a pamphlet for alcohol treatment referral to the University of Michigan Addiction Treatment Services, but will receive no further education from the research team. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Michigan Alcohol Improvement Network-Alcohol Reduction and Treatment tool | Behavioral | The intervention corrects misconceptions about alcohol use, liver disease, and alcohol treatment and matches patients to their top three choices of treatment while providing them with brief explanations of each treatment option. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of MAIN-ART Tool as Measured by Recruitment Rates | Feasibility of administration of the MAIN-ART tool will be determined by recruitment rates and retention rates (as measured at 6 months after recruitment). Study recruitment started on 23 September, 2020 and concluded on 10 January 2022. The results reflect the number and percent of those patients who were approached, were determined to be eligible, and were consented. | Up to 6 months |
| Feasibility of MAIN-ART Tool as Measured by Retention Rates | Feasibility of administration of the MAIN-ART tool will be determined by recruitment rates and retention rates (as measured at 6 months after recruitment). Retention rate is shown by the number of participants who continued in the study for 6 months, and the percentage that it represents compared to those who began it but did not follow through to the end of the study (6 months). | Up to 6 months |
| Acceptability of the MAIN-ART Tool as Measured by Post-intervention Surveys | On the day the participants engage with the MAIN-ART tool, acceptability will be determined by patient-level surveys. The System usability Survey (SUS) consists of 10 questions ranging from 1 (strongly disagree) to 5 (strongly agree). A scoring algorithm which produces a range from 0 to 100 was used. Current literature suggests that a score above 68 for mean SUS is considered "above average." By "intervention," this measure means interaction with the MAIN-ART tool, which occurs only at the participant's initial visit. | Up to 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol Use Frequency as Measured by the Alcohol Timeline Follow-back (TLFB) Interview | Alcohol use will be defined according to World Health Organization (WHO) risk drinking level. WHO drinking risk levels were derived from patient reports of the number of standard drinks (defined as 0.6 ounces of absolute alcohol) consumed, which were converted to grams of pure alcohol (0.6 ounces = 14 grams). Ranging from abstinence (0 grams) to very high risk (101+ males / 61+ females grams). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Mellinger, MD, MSc | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37708435 | Derived | Mellinger JL, Medley S, Kidwell KM, Asefah H, Winder GS, Fernandez AC, Lok ASF, Blow F. Improving alcohol treatment engagement using integrated behavioral interventions in alcohol-associated liver disease: A randomized pilot trial. Hepatol Commun. 2023 Sep 15;7(10):e0181. doi: 10.1097/HC9.0000000000000181. eCollection 2023 Oct 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | MAIN-ART Behavior Tool | The Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Tool (MAIN-ART) behavioral intervention is an online web application with two modules: misconception correction and tailored, preference-sensitive alcohol use disorder (AUD) treatment matching. Michigan Alcohol Improvement Network-Alcohol Reduction and Treatment tool: The intervention corrects misconceptions about alcohol use, liver disease, and alcohol treatment and matches patients to their top three choices of treatment while providing them with brief explanations of each treatment option. |
| FG001 | Routine Care | Patients randomized to usual care will receive a pamphlet for alcohol treatment referral to the University of Michigan Addiction Treatment Services, but will receive no further education from the research team. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MAIN-ART Behavior Tool | The Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Tool (MAIN-ART) behavioral intervention is an online web application with two modules: misconception correction and tailored, preference-sensitive alcohol use disorder (AUD) treatment matching. Michigan Alcohol Improvement Network-Alcohol Reduction and Treatment tool: The intervention corrects misconceptions about alcohol use, liver disease, and alcohol treatment and matches patients to their top three choices of treatment while providing them with brief explanations of each treatment option. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Feasibility of MAIN-ART Tool as Measured by Recruitment Rates | Feasibility of administration of the MAIN-ART tool will be determined by recruitment rates and retention rates (as measured at 6 months after recruitment). Study recruitment started on 23 September, 2020 and concluded on 10 January 2022. The results reflect the number and percent of those patients who were approached, were determined to be eligible, and were consented. | This population is prior to consent and includes the patients who were ultimately excluded due to not meeting study criteria, cancellation, not showing up to appointments, being unreachable via phone, or for declining participation in the study. | Posted | Count of Participants | Participants | Up to 6 months |
|
Up to 6 months.
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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 | MAIN-ART Behavior Tool | The Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Tool (MAIN-ART) behavioral intervention is an online web application with two modules: misconception correction and tailored, preference-sensitive alcohol use disorder (AUD) treatment matching. Michigan Alcohol Improvement Network-Alcohol Reduction and Treatment tool: The intervention corrects misconceptions about alcohol use, liver disease, and alcohol treatment and matches patients to their top three choices of treatment while providing them with brief explanations of each treatment option. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Mellinger | University of Michigan | 734-232-0284 | jmelling@umich.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 | Jun 18, 2020 | Jun 29, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 21, 2020 | Oct 7, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
| Baseline and 6 months |
| Alcohol Treatment Engagement as Measured by Number of Participants Who Engaged in Any Alcohol Cessation or Reduction Visit as Measured by Self-report. | Alcohol treatment engagement will be defined as at least one visit with formal, external assistance in alcohol cessation or reduction including inpatient rehabilitation services, out patient alcohol cessation programs, engagement in therapy of any kind tailored for alcohol cessation, and engagement in any group therapy or support groups for alcohol cessation including alcoholics anonymous, 12 step facilitation and etc. | Up to 6 months |
| Withdrawal by Subject |
|
| BG001 | Routine Care | Patients randomized to usual care will receive a pamphlet for alcohol treatment referral to the University of Michigan Addiction Treatment Services, but will receive no further education from the research team. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Alcohol-Related Liver Disease (ALD) Severity | Count of Participants | Participants |
|
| Cirrhosis Diagnosis | Count of Participants | Participants |
|
| Self-reported last drink | Mean | Standard Deviation | Days |
|
|
|
| Primary | Feasibility of MAIN-ART Tool as Measured by Retention Rates | Feasibility of administration of the MAIN-ART tool will be determined by recruitment rates and retention rates (as measured at 6 months after recruitment). Retention rate is shown by the number of participants who continued in the study for 6 months, and the percentage that it represents compared to those who began it but did not follow through to the end of the study (6 months). | Posted | Count of Participants | Participants | Up to 6 months |
|
|
|
| Primary | Acceptability of the MAIN-ART Tool as Measured by Post-intervention Surveys | On the day the participants engage with the MAIN-ART tool, acceptability will be determined by patient-level surveys. The System usability Survey (SUS) consists of 10 questions ranging from 1 (strongly disagree) to 5 (strongly agree). A scoring algorithm which produces a range from 0 to 100 was used. Current literature suggests that a score above 68 for mean SUS is considered "above average." By "intervention," this measure means interaction with the MAIN-ART tool, which occurs only at the participant's initial visit. | Only subjects randomized to the intervention MAIN-ART behavioral tool were assessed in the intervention group. Because this intervention was given at the initial visit, all participants who were randomized to the MAIN-ART tool arm are available for analysis. | Posted | Mean | Full Range | score on a scale | Up to 1 hour |
|
|
|
| Secondary | Alcohol Use Frequency as Measured by the Alcohol Timeline Follow-back (TLFB) Interview | Alcohol use will be defined according to World Health Organization (WHO) risk drinking level. WHO drinking risk levels were derived from patient reports of the number of standard drinks (defined as 0.6 ounces of absolute alcohol) consumed, which were converted to grams of pure alcohol (0.6 ounces = 14 grams). Ranging from abstinence (0 grams) to very high risk (101+ males / 61+ females grams). | Baseline measure data includes all participants whose data was collected at baseline. The participants at 6 months includes only those who completed the study. | Posted | Mean | Standard Deviation | Grams per day | Baseline and 6 months |
|
|
|
|
| Secondary | Alcohol Treatment Engagement as Measured by Number of Participants Who Engaged in Any Alcohol Cessation or Reduction Visit as Measured by Self-report. | Alcohol treatment engagement will be defined as at least one visit with formal, external assistance in alcohol cessation or reduction including inpatient rehabilitation services, out patient alcohol cessation programs, engagement in therapy of any kind tailored for alcohol cessation, and engagement in any group therapy or support groups for alcohol cessation including alcoholics anonymous, 12 step facilitation and etc. | All participants involved in the initial use of the MAIN-ART tool or who received routine care are analyzed to evaluate what percent engaged with alcohol treatment by the end of the study. | Posted | Count of Participants | Participants | Up to 6 months |
|
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Routine Care | Patients randomized to usual care will receive a pamphlet for alcohol treatment referral to the University of Michigan Addiction Treatment Services, but will receive no further education from the research team. | 3 | 30 | 0 | 30 | 0 | 30 |
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| 6 months |
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