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

Sponsor
Royal Free Hospital NHS Foundation Trust (Other)
Overall Status
Unknown status
CT.gov ID
NCT03474328
Collaborator
(none)
60
Enrollment
1
Arm
30.2
Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: AlcoChange
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
AlcoChange: An Open Label Pilot Study of Smartphone Monitoring for Alcoholic Liver Disease
Actual Study Start Date :
Apr 25, 2016
Anticipated Primary Completion Date :
Nov 1, 2018
Anticipated Study Completion Date :
Nov 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment arm

Device: AlcoChange
Smartphone app and breathalyser

Outcome Measures

Primary Outcome Measures

  1. Self-reported alcohol consumption (average/week) [3-month study period]

    Assessed by time line follow back method over study period

Secondary Outcome Measures

  1. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • presence of ARLD

  • age 18-70

  • intent to maintain abstinence

  • possession of compatible smartphone

Exclusion Criteria:
  • inability to provide consent.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Royal Free Hospital NHS Foundation Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gautam Mehta, Honorary Consultant and Senior Lecturer in Hepatology, Royal Free Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT03474328
Other Study ID Numbers:
  • 16LO0290
First Posted:
Mar 22, 2018
Last Update Posted:
Aug 31, 2018
Last Verified:
Aug 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Liver Diseases
Liver Diseases, Alcoholic
Alcohol-Related Disorders

Study Results

No Results Posted as of Aug 31, 2018