Alcohol-Related Disorders Clinical Trial
Official title:
AlcoChange: An Open Label Pilot Study of Smartphone Monitoring for Alcoholic Liver Disease
Verified date | August 2018 |
Source | Royal Free Hospital NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Alcohol contributes to over 5% of deaths worldwide, and death rates from alcohol-related
liver disease (ARLD) in the UK continue to rise sharply. On-going alcohol use in ARLD leads
to markedly increased mortality (Thursz et al, 2015), and maintaining abstinence is a key
therapeutic goal. However, there are no effective pharmacological therapies for maintaining
abstinence. Brief intervention (BI) is an effective psychological tool for reducing alcohol
use, but is difficult to scale widely.
AlcoChange is a smartphone app and breathalyser (AlcoChange), which facilitates
self-monitoring and delivers BIs in response to patient triggers. The aim of this open-label
study is provide AlcoChange to 60 patients with ARLD, to determine compliance with the
app/breathalyser and changes in self-reported alcohol consumption.
Recruitment of inpatients/outpatients with ARLD and recent alcohol use will take place at
Royal Free London. The inclusion criteria are: intent to maintain abstinence, possession of
compatible smartphone. The exclusion criteria are: inability to provide consent. Participants
will be assessed at baseline and 3-months. The primary endpoint is self-reported alcohol use
(units/week, timeline follow-back). Secondary endpoint is compliance with the app (monitored
remotely).
Status | Active, not recruiting |
Enrollment | 60 |
Est. completion date | November 2018 |
Est. primary completion date | November 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - presence of ARLD - age 18-70 - intent to maintain abstinence - possession of compatible smartphone Exclusion Criteria: - inability to provide consent. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Royal Free Hospital NHS Foundation Trust |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Self-reported alcohol consumption (average/week) | Assessed by time line follow back method over study period | 3-month study period | |
Secondary | Compliance with the app (no. of logins, duration spent on the app) | This will be assessed independently, and for associations of compliance with the app and changes in alcohol consumption (primary endpoint) | 3-month study period |
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