NCT03388320

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 2, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

April 24, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

2.7 years

First QC Date

December 22, 2017

Last Update Submit

March 11, 2019

Conditions

Liver Diseases, Alcoholic

Outcome Measures

Primary Outcomes (1)

  • Rates of recidivism

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

    6 months

Secondary Outcomes (1)

  • Use of A-CHESS

    6 months

Study Arms (1)

Participants receiving A-CHESS

EXPERIMENTAL

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

Device: A-CHESS

Interventions

A-CHESSDEVICE

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

Participants receiving A-CHESS

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

New York, New York, 10021, United States

RECRUITING

MeSH Terms

Conditions

Liver Diseases, Alcoholic

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Study Officials

  • Robert S Brown, MD, MPH

    Weill Cornell Medical College/NYPH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole T Shen, MD

CONTACT

3146095911nts9004@nyp.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 22, 2017

First Posted

January 2, 2018

Study Start

April 24, 2018

Primary Completion

January 15, 2021

Study Completion

December 1, 2021

Last Updated

March 13, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)