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Using Addiction Comprehensive Health Enhancement Support System (ACHESS) in an Alcoholic Liver Disease Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03388320
Recruitment Status : Unknown
Verified March 2019 by Nicole T Shen, New York Presbyterian Hospital.
Recruitment status was:  Recruiting
First Posted : January 2, 2018
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
University of Wisconsin, Madison
Information provided by (Responsible Party):
Nicole T Shen, New York Presbyterian Hospital

Study Description
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Brief Summary:
This is a pilot study examining whether an evidence-based recovery support smartphone application, the Addiction Comprehensive Health Enhancement Support System (A-CHESS), can decrease alcohol recidivism in a previously unstudied group of patients with alcoholic liver disease (ALD).

Condition or disease Intervention/treatment Phase
Liver Diseases, Alcoholic Device: A-CHESS Not Applicable

Detailed Description:
A-CHESS is a smartphone application developed by the University of Wisconsin-Madison based on self-determination theory, with a previous randomized clinical trial showing that use of the app resulted in significantly fewer risky drinking days in patients leaving treatment for alcohol-use disorders. The application is downloaded to the participant's smartphone, and provides ongoing access to peer support and educational materials, monitoring of the risk of relapse, and delivery of reminders and encouragements to the patient. The application also has a survey platform to assess and reassess the participants' most recent alcohol consumption, quality of life, and experience using the application. We anticipate that use of the A-CHESS app will result in decreased drinking and improved abstinence, identifying a potential intervention to offer patients with ALD to improve their mortality, liver disease, and likelihood of liver transplant candidacy status.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Using Addiction Comprehensive Health Enhancement Support System (ACHESS) in an Alcoholic Liver Disease Population
Actual Study Start Date : April 24, 2018
Estimated Primary Completion Date : January 15, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: Participants receiving A-CHESS
Participants will be provided access to the smartphone application A-CHESS (intervention) that will be downloaded to their phone.
 Device: A-CHESS
Use of smartphone application: Addiction Comprehensive Health Enhancement Support System (A-CHESS)


Outcome Measures
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Primary Outcome Measures :
  1. Rates of recidivism [ Time Frame: 6 months ]
    Rates of recidivism in this population using A-CHESS will be compared to historical control rates


Secondary Outcome Measures :
  1. Use of A-CHESS [ Time Frame: 6 months ]
    The association between the extent to which patients use the A-CHESS application and their recidivism; to compare use of the A-CHESS app among subjects who drink and remain abstinent.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Alcoholic liver disease
  • Followed or seen at New York Presbyterian Hospital / Weill Cornell Medical Center
  • English speaking
  • Access to a smartphone

Exclusion Criteria:

  • Unable to consent
  • Primary language other than English
  • No access to a smartphone
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03388320


Contacts
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Contact: Nicole T Shen, MD 3146095911 nts9004@nyp.org

Locations
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United States, New York
New York Presbyterian Hospital - Weill Cornell Medicine and Columbia University Medical Center Recruiting
New York, New York, United States, 10021
Contact: Nicole T Shen, MD    314-609-5911    nts9004@nyp.org   
Contact: Cecilia M Mero    (646) 962-9358    cmm2002@med.cornell.edu   
Sponsors and Collaborators
New York Presbyterian Hospital
University of Wisconsin, Madison
Investigators
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Principal Investigator: Robert S Brown, MD, MPH Weill Cornell Medical College/NYPH
More Information
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Responsible Party: Nicole T Shen, Principal Investigator, New York Presbyterian Hospital
ClinicalTrials.gov Identifier: NCT03388320    
Other Study ID Numbers: 1704018122
First Posted: January 2, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Liver Diseases, Alcoholic
Digestive System Diseases
Alcohol-Induced Disorders
 Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders