Liver Diseases, AlcoholicNCT03388320
Using Addiction Comprehensive Health Enhancement Support System (ACHESS) in an Alcoholic Liver Disease Population
A study testing A-CHESS in people with Liver Diseases, Alcoholic, run by New York Presbyterian Hospital at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Diseases, Alcoholic
- What is being tested?
- A-CHESS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2018to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Alcoholic liver disease
- Followed or seen at New York Presbyterian Hospital / Weill Cornell Medical Center
- English speaking
- Access to a smartphone
Who cannot join
- Unable to consent
- Primary language other than English
- No access to a smartphone
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
New York Presbyterian Hospital - Weill Cornell Medicine and Columbia University Medical Center
New York, New York, 10021
Nicole T Shen, MD, 314-609-5911, nts9004@nyp.org
Cecilia M Mero, (646) 962-9358, cmm2002@med.cornell.edu
About this study
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.
- Conditions
- Liver Diseases, Alcoholic
- Being tested
- A-CHESS
- Medical subject headings
- Liver Diseases, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A-CHESSDevice
Use of smartphone application: Addiction Comprehensive Health Enhancement Support System (A-CHESS)
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving A-CHESS | Experimental | Participants will be provided access to the smartphone application A-CHESS (intervention) that will be downloaded to their phone. Receives: Device: A-CHESS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of recidivism
Rates of recidivism in this population using A-CHESS will be compared to historical control rates
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start24 Apr 2018
- Primary completion15 Jan 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Diseases, AlcoholicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York Presbyterian Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wisconsin, Madison
- Responsible party
- Principal investigator, Nicole T Shen, New York Presbyterian Hospital
- Investigators
- Robert S Brown, MD, MPH, Principal investigator, Weill Cornell Medical College/NYPH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388320
- Sponsor's protocol ID
- 1704018122
- Status last verified
- Mar 2019
- First submitted
- 22 Dec 2017
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Addiction Comprehensive Health Enhancement Support System (ACHESS) in an Alcoholic Liver Disease Population
- ClinicalTrials.gov ID
- NCT03388320
- Acronym / sponsor ID
- 1704018122
- Conditions
- Liver Diseases, Alcoholic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- New York Presbyterian HospitalUniversity, hospital or other
- Collaborators
- University of Wisconsin, Madison
- Study start
- 24 Apr 2018 (actual)
- Primary completion
- 15 Jan 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 2 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants receiving A-CHESS | Experimental | Device: A-CHESSParticipants will be provided access to the smartphone application A-CHESS (intervention) that will be downloaded to their phone. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Alcoholic liver disease
- Followed or seen at New York Presbyterian Hospital / Weill Cornell Medical Center
- English speaking
- Access to a smartphone
Key exclusion criteria (3 listed)
- Unable to consent
- Primary language other than English
- No access to a smartphone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A-CHESSUse of smartphone application: Addiction Comprehensive Health Enhancement Support System (A-CHESS) | Device | Participants receiving A-CHESS |
Primary outcome
Rates of recidivism
Time frame: 6 months
Rates of recidivism in this population using A-CHESS will be compared to historical control rates
1 secondary outcome
Use of A-CHESS
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert S Brown, MD, MPH principal investigator
Weill Cornell Medical College/NYPH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A-CHESS in people with Liver Diseases, Alcoholic, run by New York Presbyterian Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicole T Shen, MD (3146095911, nts9004@nyp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of recidivism (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.