CClinicalTrials.gg
Status unknownNCT03388320Updated Mar 13, 2019

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

An interventional study of A-CHESS in Liver Diseases, Alcoholic, sponsored by New York Presbyterian Hospital. Status unknown at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-03-13.

Sponsored by New York Presbyterian Hospital · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Liver Diseases, Alcoholic
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Unable to consent
  • Primary language other than English
  • No access to a smartphone
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • 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

Interventions

  • DeviceA-CHESS

    Use of smartphone application: Addiction Comprehensive Health Enhancement Support System (A-CHESS)

05

What researchers measure

Primary outcomes

  1. Rates of recidivism

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

    Time frame: 6 months

Secondary outcomes

  1. 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.

    Time frame: 6 months

06

Study locations

1 of 1 sites recruiting
  • New York Presbyterian Hospital - Weill Cornell Medicine and Columbia University Medical Center
    New York, New York 10021, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03388320
Lead sponsor
New York Presbyterian Hospital
Collaborators
University of Wisconsin, Madison
Responsible party
Nicole T Shen (Principal Investigator, New York Presbyterian Hospital) — Principal investigator
First posted
Jan 2, 2018
Start date
Apr 24, 2018
Primary completion
Jan 15, 2021 (estimated)
Completion
Dec 1, 2021 (estimated)
Last update
Mar 13, 2019

Study contacts

Nicole T Shen, MD
Contact
nts9004@nyp.org
3146095911
Robert S Brown, MD, MPH
principal investigator · Weill Cornell Medical College/NYPH

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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