Alcohol Use DisorderDALCNCT06319222
Implementation of a Digital Clinic for Alcohol-associated Liver Disease and Alcohol Use Disorder (DALC)
A study testing DALC Digital Clinic in people with Alcohol Use Disorder and Liver Diseases, run by Mayo Clinic at 2 sites in United States.
Trial summary
The purpose of this study is to determine whether a multidisciplinary digital clinic will improve health outcomes, reduce costs, increase access, and improve provider satisfaction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder, Liver Diseases
- What is being tested?
- DALC Digital Clinic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Mar 2024to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Provider-Hepatology Providers at Mayo Clinic Rochester and Scottsdale
- Patient-Age ≥ 18 y.o.
- Patient-Alcohol-associated liver disease
Who cannot join
- Provider-Providers in other divisions
- Patient-Inability to provide consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic
Rochester, Minnesota, 55905
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
About this study
Official title: Implementation of a Digital Clinic for Alcohol-associated Liver Disease and Alcohol Use Disorder (DALC): A Randomized Pragmatic Clinical Trial
The purpose of this study is to determine whether a multidisciplinary digital clinic will improve health outcomes, reduce costs, increase access, and improve provider satisfaction.
The primary aim of this study is to improve clinical outcomes in patients with ALD through the implementation of a novel digital health platform for personalized multi-disciplinary treatment of patients with ALD and AUD. Secondary aims include improvement in provider and patient-reported outcomes including satisfaction with AUD treatment.
Read the detailed description
This will be a pilot study with a pragmatic trial design wherein all hepatology providers at the Mayo Clinic in Rochester, MN and Scottsdale, AZ will be invited to participate in the study. Consented providers will be randomized to the Digital ALD/AUD Clinic (DALC) arm or standard of care. Provides randomized to standard of care arm will continue to enroll their patients with ALD in the Interactive Care Plan (ICP), a nursing led program started at Mayo in 2021 for longitudinal remote care of patients with compensated and decompensated cirrhosis. All patients will receive nursing education on alcohol abstinence at ICP enrollment and longitudinal management of their liver disease (current state). Providers randomized to the intervention arm will be able to refer their patients with ALD, to the DALC in addition to standard of care.
The target sample size will be 40 providers (20 providers per arm) and the investigators anticipate 150 patients with ALD will be seen during the study period across both arms. The number of ICP eligible patients seen versus the number of ICP referred patients will be recorded for all providers. Clinically relevant outcomes including hepatic decompensation, MELD 3.0 score, liver chemistries, alcohol use or relapse, liver-related hospitalizations, medication compliance, and mortality will be recorded as part of current ICP program, in both arms. Data will be collected retrospectively from the available medical records at the end of the study period, and no research contact will be made with the patients after initial consent for those patients being offered the DALC. The study duration will be 6 months after the initial Hepatology appointment. At study enrollment and completion, providers will be asked to fill out a survey regarding their satisfaction with ALD/AUD treatment. Consented providers will be informed that they may drop out of the study at any time.
- Conditions
- Alcohol Use Disorder, Liver Diseases
- Being tested
- DALC Digital Clinic
- Keywords
- Alcohol, Liver, Disorder
- Medical subject headings
- Alcoholism, Liver Diseases, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DALC Digital ClinicOther
Providers randomized to the intervention arm will be able to refer their patients with ALD, to the DALC in addition to standard of care. Patients with providers randomized to the intervention arm will be consented by the study team. After appropriate consent, the referred patients will be instructed by our study team to download the RTP application in their smart devices (smartphones or tablets).
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Arm | No intervention | Primary care providers will treat subject per standard of care utilizing the Interactive Care Plan program. |
| Digital Clinic Arm | Other | The Ria Treatment Platform (RTP) application will be downloaded onto the patient's smart phone or tablet. Receives: Other: DALC Digital Clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median delta MELD-3.0 from baseline to end of study.
The primary aim of this study is to improve clinical outcomes in patients with ALD as defined as median delta MELD-3.0 from baseline to the end of the study.
Measured: 6 months
Secondary outcomes (3)
Sustained alcohol abstinence
Secondary aims include sustained alcohol abstinence which is obtained by asking the patient if they are continuing to not drink alcohol
Measured: 6 months
Reduction of Number of hospitalizations
Secondary outcome measures include a reduction of number of hospitalizations in the DALC arm compared to the standard of care arm.
Measured: 6 months
Greater provider satisfaction in DALC arm
Secondary outcome measures include greater provider satisfaction with AUD management in the DALC compared to standard of care based on surveys answered by providers. Provider outcome will be assessed by providing the provider a 12 question questionnaire with options to answer Extremely satisfied (5 pts), moderately satisfied (4 pts), neutral (3 pts), moderately dissatisfied (2 pts), very dissatisfied (1pt). The greater the points the greater the satisfaction.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start12 Mar 2024
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Ria Health
- Responsible party
- Principal investigator, Douglas (Doug) A. Simonetto, Mayo Clinic
- Investigators
- Douglas Simonetto, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319222
- Sponsor's protocol ID
- 23-007870
- Acronym
- DALC
- Status last verified
- Aug 2026
- First submitted
- 13 Mar 2024
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Digital Clinic for Alcohol-associated Liver Disease and Alcohol Use Disorder (DALC): A Randomized Pragmatic Clinical Trial
- ClinicalTrials.gov ID
- NCT06319222
- Acronym / sponsor ID
- DALC / 23-007870
- Conditions
- Alcohol Use Disorder, Liver Diseases
- Keywords
- Alcohol, Liver, Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Ria Health
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether a multidisciplinary digital clinic will improve health outcomes, reduce costs, increase access, and improve provider satisfaction.
The primary aim of this study is to improve clinical outcomes in patients with ALD through the implementation of a novel digital health platform for personalized multi-disciplinary treatment of patients with ALD and AUD. Secondary aims include improvement in provider and patient-reported outcomes including satisfaction with AUD treatment.
Detailed description
This will be a pilot study with a pragmatic trial design wherein all hepatology providers at the Mayo Clinic in Rochester, MN and Scottsdale, AZ will be invited to participate in the study. Consented providers will be randomized to the Digital ALD/AUD Clinic (DALC) arm or standard of care. Provides randomized to standard of care arm will continue to enroll their patients with ALD in the Interactive Care Plan (ICP), a nursing led program started at Mayo in 2021 for longitudinal remote care of patients with compensated and decompensated cirrhosis. All patients will receive nursing education on alcohol abstinence at ICP enrollment and longitudinal management of their liver disease (current state). Providers randomized to the intervention arm will be able to refer their patients with ALD, to the DALC in addition to standard of care.
The target sample size will be 40 providers (20 providers per arm) and the investigators anticipate 150 patients with ALD will be seen during the study period across both arms. The number of ICP eligible patients seen versus the number of ICP referred patients will be recorded for all providers. Clinically relevant outcomes including hepatic decompensation, MELD 3.0 score, liver chemistries, alcohol use or relapse, liver-related hospitalizations, medication compliance, and mortality will be recorded as part of current ICP program, in both arms. Data will be collected retrospectively from the available medical records at the end of the study period, and no research contact will be made with the patients after initial consent for those patients being offered the DALC. The study duration will be 6 months after the initial Hepatology appointment. At study enrollment and completion, providers will be asked to fill out a survey regarding their satisfaction with ALD/AUD treatment. Consented providers will be informed that they may drop out of the study at any time.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Arm | No intervention | –Primary care providers will treat subject per standard of care utilizing the Interactive Care Plan program. |
| Digital Clinic Arm | Other | Other: DALC Digital ClinicThe Ria Treatment Platform (RTP) application will be downloaded onto the patient's smart phone or tablet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Provider-Hepatology Providers at Mayo Clinic Rochester and Scottsdale
- Patient-Age ≥ 18 y.o.
- Patient-Alcohol-associated liver disease
Key exclusion criteria (2 listed)
- Provider-Providers in other divisions
- Patient-Inability to provide consent
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 |
|---|---|---|
| DALC Digital ClinicProviders randomized to the intervention arm will be able to refer their patients with ALD, to the DALC in addition to standard of care. Patients with providers randomized to the intervention arm will be consented by the study team. After appropriate consent, the referred patients will be instructed by our study team to download the RTP application in their smart devices (smartphones or tablets). | Other | Digital Clinic Arm |
Primary outcome
Median delta MELD-3.0 from baseline to end of study.
Time frame: 6 months
The primary aim of this study is to improve clinical outcomes in patients with ALD as defined as median delta MELD-3.0 from baseline to the end of the study.
3 secondary outcomes
Sustained alcohol abstinence
Time frame: 6 months
Reduction of Number of hospitalizations
Time frame: 6 months
Greater provider satisfaction in DALC arm
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- 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.
Douglas Simonetto, MD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DALC Digital Clinic in people with Alcohol Use Disorder and Liver Diseases, run by Mayo Clinic at 2 sites 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 3 inclusion and 2 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 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Median delta MELD-3.0 from baseline to end of study. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2026.