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

Primary Purpose

Liver Diseases, Alcoholic

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
A-CHESS
Sponsored by
New York Presbyterian Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Liver Diseases, Alcoholic

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York Presbyterian Hospital - Weill Cornell Medicine and Columbia University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants receiving A-CHESS

Arm Description

Participants will be provided access to the smartphone application A-CHESS (intervention) that will be downloaded to their phone.

Outcomes

Primary Outcome Measures

Rates of recidivism
Rates of recidivism in this population using A-CHESS will be compared to historical control rates

Secondary Outcome Measures

Use of A-CHESS
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.

Full Information

First Posted
December 22, 2017
Last Updated
March 11, 2019
Sponsor
New York Presbyterian Hospital
Collaborators
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT03388320
Brief Title
Using Addiction Comprehensive Health Enhancement Support System (ACHESS) in an Alcoholic Liver Disease Population
Official Title
Using Addiction Comprehensive Health Enhancement Support System (ACHESS) in an Alcoholic Liver Disease Population
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 24, 2018 (Actual)
Primary Completion Date
January 15, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York Presbyterian Hospital
Collaborators
University of Wisconsin, Madison

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Diseases, Alcoholic

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants receiving A-CHESS
Arm Type
Experimental
Arm Description
Participants will be provided access to the smartphone application A-CHESS (intervention) that will be downloaded to their phone.
Intervention Type
Device
Intervention Name(s)
A-CHESS
Intervention Description
Use of smartphone application: Addiction Comprehensive Health Enhancement Support System (A-CHESS)
Primary Outcome Measure Information:
Title
Rates of recidivism
Description
Rates of recidivism in this population using A-CHESS will be compared to historical control rates
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Use of A-CHESS
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole T Shen, MD
Phone
3146095911
Email
nts9004@nyp.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert S Brown, MD, MPH
Organizational Affiliation
Weill Cornell Medical College/NYPH
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Presbyterian Hospital - Weill Cornell Medicine and Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole T Shen, MD
Phone
314-609-5911
Email
nts9004@nyp.org
First Name & Middle Initial & Last Name & Degree
Cecilia M Mero
Phone
(646) 962-9358
Email
cmm2002@med.cornell.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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