AlcoChange: An Open Label Pilot Study of Smartphone Monitoring for Alcoholic Liver Disease
1 other identifier
interventional
60
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2016
Typical duration for not_applicable
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
Study Start
First participant enrolled
April 25, 2016
CompletedFirst Submitted
Initial submission to the registry
March 15, 2018
CompletedFirst Posted
Study publicly available on registry
March 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedAugust 31, 2018
August 1, 2018
2.5 years
March 15, 2018
August 29, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Self-reported alcohol consumption (average/week)
Assessed by time line follow back method over study period
3-month study period
Secondary Outcomes (1)
Compliance with the app (no. of logins, duration spent on the app)
3-month study period
Study Arms (1)
Treatment arm
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- presence of ARLD
- age 18-70
- intent to maintain abstinence
- possession of compatible smartphone
You may not qualify if:
- \- inability to provide consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Honorary Consultant and Senior Lecturer in Hepatology
Study Record Dates
First Submitted
March 15, 2018
First Posted
March 22, 2018
Study Start
April 25, 2016
Primary Completion
November 1, 2018
Study Completion
November 1, 2018
Last Updated
August 31, 2018
Record last verified: 2018-08