A Study to Evaluate Smartphone-based Digital Phenotyping for Relapse Prediction in Alcohol-associated Liver Disease

Overview

About this study

The primary aim of this study is to define a comprehensive digital phenotype that predicts risk for near-future relapse or relapse in alcohol use in patients with alcohol-associated liver disease.

The secondary aim of this study is to assess the relationship between this digital phenotype and markers of disease severity outcome, including MELD score and readmission rates.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Aged 18 or over.
  • Diagnosis of alcohol-associated liver disease and alcohol use disorder:
    • The diagnosis of ALD will be determined by a hepatologist based on history of regular and excessive alcohol consumption in the absence of other causes of liver cirrhosis or acute hepatitis, compatible clinical, imaging, and laboratory findings and typical histology on liver biopsy, if performed;
    • The diagnosis of AUD will be determined by a hepatologist and/or addiction psychiatrist based on history obtained that is consistent with DSM-5 diagnostic criteria for AUD (all categories of mild, moderate, and severe considered eligible).
  • Capacity to provide consent.
  • Access to a smartphone using Android operating system, cellular data, and wireless internet connection through the smartphone device.

Exclusion Criteria:

  • Inability to respond to smartphone-delivered questionnaires.
  • Inability to send and receive text messages.
  • Moderate to severe hepatic encephalopathy, defined by West-Haven score of 3 or higher.
  • Severe psychiatric comorbidity, not controlled on pharmacological or non-pharmacological therapy.
  • Concurrent behavioral AUD  treatment, such as enrollment in 12-step program, during 30 days of digital surveillance.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Vijay Shah, M.D.

Open for enrollment

Contact information:

Tiffany Wu M.D.

Wu.Tiffany@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20516355

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