AlcoChange: An Open Label Pilot Study of Smartphone Monitoring for Alcoholic Liver Disease

Not Applicable

• Conditions: Alcohol-Related Disorders
• Interventions: Device: AlcoChange

• Registration Number: NCT03474328
• Lead Sponsor: Royal Free Hospital NHS Foundation Trust

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-25
• Study First Submitted: 2018-03-15
• Study First Submitted QC: 2018-03-15
• Study First Posted: 2018-03-22
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-29
• Last Update Posted: 2018-08-31
• Primary Completion: 2018-11
• Study Completion: 2018-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

• presence of ARLD
• age 18-70
• intent to maintain abstinence
• possession of compatible smartphone

Exclusion Criteria

• inability to provide consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment arm	AlcoChange	-

Primary Outcome Measures

Name	Time	Method
Self-reported alcohol consumption (average/week)	3-month study period	Assessed by time line follow back method over study period

Secondary Outcome Measures

Name	Time	Method
Compliance with the app (no. of logins, duration spent on the app)	3-month study period	This will be assessed independently, and for associations of compliance with the app and changes in alcohol consumption (primary endpoint)