- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03388320
Using Addiction Comprehensive Health Enhancement Support System (ACHESS) in an Alcoholic Liver Disease Population
March 11, 2019 updated by: Nicole T Shen, New York Presbyterian Hospital
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).
Study Overview
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
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nicole T Shen, MD
- Phone Number: 3146095911
- Email: nts9004@nyp.org
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Recruiting
- New York Presbyterian Hospital - Weill Cornell Medicine and Columbia University Medical Center
-
Contact:
- Nicole T Shen, MD
- Phone Number: 314-609-5911
- Email: nts9004@nyp.org
-
Contact:
- Cecilia M Mero
- Phone Number: (646) 962-9358
- Email: cmm2002@med.cornell.edu
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Use of smartphone application: Addiction Comprehensive Health Enhancement Support System (A-CHESS)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rates of recidivism
Time Frame: 6 months
|
Rates of recidivism in this population using A-CHESS will be compared to historical control rates
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Robert S Brown, MD, MPH, Weill Cornell Medical College/NYPH
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 24, 2018
Primary Completion (Anticipated)
January 15, 2021
Study Completion (Anticipated)
December 1, 2021
Study Registration Dates
First Submitted
December 22, 2017
First Submitted That Met QC Criteria
December 22, 2017
First Posted (Actual)
January 2, 2018
Study Record Updates
Last Update Posted (Actual)
March 13, 2019
Last Update Submitted That Met QC Criteria
March 11, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1704018122
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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