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

NCT ID: NCT03474328

Last Updated: 2018-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-25

Study Completion Date

2018-11-30

Brief Summary

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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

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Conditions

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Alcohol-Related Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Treatment arm

Group Type EXPERIMENTAL

AlcoChange

Intervention Type DEVICE

Smartphone app and breathalyser

Interventions

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AlcoChange

Smartphone app and breathalyser

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- inability to provide consent.
Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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Royal Free Hospital NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Gautam Mehta

Honorary Consultant and Senior Lecturer in Hepatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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16LO0290

Identifier Type: -

Identifier Source: org_study_id

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