Alcohol-Related DisordersMAIN-ARTNCT04473482

Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Trial

A study testing Michigan Alcohol Improvement Network-Alcohol Reduction and Treatment tool in people with Alcohol-Related Disorders and Liver Diseases, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Alcohol-Related Disorders, Liver Diseases
What is being tested?: Michigan Alcohol Improvement Network-Alcohol Reduction and Treatment tool
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 23 Sep 2020to 30 Jun 2022
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Enrolled at University of Michigan general hepatology clinics or inpatient wards
Documented diagnosis of alcohol-associated cirrhosis or alcoholic hepatitis or alcohol-related liver disease of any stage
Drinking of any amount of alcohol within the 6 months prior to recruitment
No alcohol use treatment within the past 1 month
Access to a phone for purposes of follow-up

Who cannot join

Active alcohol use treatment
Undergoing active evaluation for liver transplantation, is listed for liver transplant, or is post-transplantation.
Is enrolled in the multidisciplinary alcohol-related liver disease clinic at Michigan Medicine

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of Michigan
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

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.

Conditions: Alcohol-Related Disorders, Liver Diseases
Being tested: Michigan Alcohol Improvement Network-Alcohol Reduction and Treatment tool
Medical subject headings: Alcohol-Related Disorders, Liver Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Michigan Alcohol Improvement Network-Alcohol Reduction and Treatment toolBehavioural
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.

Study groups in NCT04473482
Study group	Role	What they receive
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. Receives: Behavioral: Michigan Alcohol Improvement Network-Alcohol Reduction and Treatment tool
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).
Measured: 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.
Measured: Up to 1 hour

Secondary outcomes (2)

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).
Measured: 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.
Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Sep 202030 Jun 2022

First posted16 Jul 2020
Study start23 Sep 2020
Primary completion30 Jun 2022
Study completion30 Jun 2022

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 (1)Papers the sponsor has linked to this study.
Other trials for Alcohol-Related DisordersStudies of the same condition, open and under way.
More trials run by University of MichiganThe 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
Masking: Single blind
Who is masked: Investigator
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04473482
Sponsor's protocol ID: HUM00174946
Other IDs: 5K23AA026333-02
Acronym: MAIN-ART
Status last verified: Aug 2023
First submitted: 13 Jul 2020
Last updated: 30 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 37708435

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Trial
ClinicalTrials.gov ID: NCT04473482
Acronym / sponsor ID: MAIN-ART / HUM00174946
Conditions: Alcohol-Related Disorders, Liver Diseases
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study start: 23 Sep 2020 (actual)
Primary completion: 30 Jun 2022 (actual)
Study completion: 30 Jun 2022 (actual)
First posted: 16 Jul 2020 (actual)
Results: Posted 30 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
MAIN-ART Behavior Tool	Experimental	Behavioral: Michigan Alcohol Improvement Network-Alcohol Reduction and Treatment toolThe 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.
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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Enrolled at University of Michigan general hepatology clinics or inpatient wards
Documented diagnosis of alcohol-associated cirrhosis or alcoholic hepatitis or alcohol-related liver disease of any stage
Drinking of any amount of alcohol within the 6 months prior to recruitment
No alcohol use treatment within the past 1 month
Access to a phone for purposes of follow-up

Key exclusion criteria (3 listed)

Active alcohol use treatment
Undergoing active evaluation for liver transplantation, is listed for liver transplant, or is post-transplantation.
Is enrolled in the multidisciplinary alcohol-related liver disease clinic at Michigan Medicine

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
Michigan Alcohol Improvement Network-Alcohol Reduction and Treatment toolThe 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.	Behavioural	MAIN-ART Behavior Tool

Primary outcome

Feasibility of MAIN-ART Tool as Measured by Recruitment Rates
Time frame: Up to 6 months
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.
Feasibility of MAIN-ART Tool as Measured by Retention Rates
Time frame: Up to 6 months
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).
Acceptability of the MAIN-ART Tool as Measured by Post-intervention Surveys
Time frame: Up to 1 hour
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.

2 secondary outcomes

Alcohol Use Frequency as Measured by the Alcohol Timeline Follow-back (TLFB) Interview
Time frame: 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.
Time frame: Up to 6 months

Results and safety

Results posted to the registry on 30 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MAIN-ART Behavior Tool	30	19
Routine Care	30	19

Primary outcome: Feasibility of MAIN-ART Tool as Measured by Recruitment Rates

Time frame: Up to 6 months. Count of participants. Unit: Participants

Measure	Clinical Population n = 276
Value	60

Population analysed: 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.

Primary outcome: Feasibility of MAIN-ART Tool as Measured by Retention Rates

Time frame: Up to 6 months. Count of participants. Unit: Participants

Measure	MAIN-ART Behavior Tool n = 30	Routine Care n = 30
Value	19	19

Primary outcome: Acceptability of the MAIN-ART Tool as Measured by Post-intervention Surveys

Time frame: Up to 1 hour. Mean (Full Range). Unit: score on a scale

Measure	MAIN-ART Behavior Tool n = 30
Value	70 (47.5 to 95)

Population analysed: 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.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 6 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MAIN-ART Behavior Tool	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Routine Care	0 of 30 (0%)	0 of 30 (0%)	3 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37708435Mellinger 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.
Individual participant dataSharing planned: No

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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.

Jessica Mellinger, MD, MSc principal investigator

University of Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 3 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 30 Aug 2023. 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 30 Aug 2023). 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?

Feasibility of MAIN-ART Tool as Measured by Recruitment Rates (time frame: Up to 6 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 NCT04473482, which also lists 1 linked publication.

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 30 Aug 2023.