NCT03474328

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Royal Free Hospital NHS Foundation Trust · Academic / Other
• Sex: —
• Age: —
• Healthy volunteers: Not accepted

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).

Conditions

• Alcohol-Related Disorders

Interventions

Type	Name	Description
DEVICE	AlcoChange	Smartphone app and breathalyser

Timeline

• Start date: 2016-04-25
• Primary completion: 2018-11-01
• Completion: 2018-11-01
• First posted: 2018-03-22
• Last updated: 2018-08-31