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

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ClinicalTrials.gov Identifier: NCT03388320
Recruitment Status : 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

Tracking Information
First Submitted Date  ICMJE December 22, 2017
First Posted Date  ICMJE January 2, 2018
Last Update Posted Date March 13, 2019
Actual Study Start Date  ICMJE April 24, 2018
Estimated Primary Completion Date January 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2017)
Rates of recidivism [ Time Frame: 6 months ]
Rates of recidivism in this population using A-CHESS will be compared to historical control rates
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2017)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Using Addiction Comprehensive Health Enhancement Support System (ACHESS) in an Alcoholic Liver Disease Population
Official Title  ICMJE Using Addiction Comprehensive Health Enhancement Support System (ACHESS) in an Alcoholic Liver Disease Population
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Liver Diseases, Alcoholic
Intervention  ICMJE Device: A-CHESS
Use of smartphone application: Addiction Comprehensive Health Enhancement Support System (A-CHESS)
Study Arms  ICMJE Experimental: Participants receiving A-CHESS
Participants will be provided access to the smartphone application A-CHESS (intervention) that will be downloaded to their phone.
Intervention: Device: A-CHESS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 22, 2017)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2021
Estimated Primary Completion Date January 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nicole T Shen, MD 3146095911 nts9004@nyp.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03388320
Other Study ID Numbers  ICMJE 1704018122
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nicole T Shen, New York Presbyterian Hospital
Study Sponsor  ICMJE New York Presbyterian Hospital
Collaborators  ICMJE University of Wisconsin, Madison
Investigators  ICMJE
Principal Investigator: Robert S Brown, MD, MPH Weill Cornell Medical College/NYPH
PRS Account New York Presbyterian Hospital
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP