AlcoChange: An Open Label Pilot Study of Smartphone Monitoring for Alcoholic Liver Disease
Primary Purpose
Alcohol-Related Disorders
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
AlcoChange
Sponsored by
About this trial
This is an interventional supportive care trial for Alcohol-Related Disorders
Eligibility Criteria
Inclusion Criteria:
- presence of ARLD
- age 18-70
- intent to maintain abstinence
- possession of compatible smartphone
Exclusion Criteria:
- inability to provide consent.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment arm
Arm Description
Outcomes
Primary Outcome Measures
Self-reported alcohol consumption (average/week)
Assessed by time line follow back method over study period
Secondary Outcome Measures
Compliance with the app (no. of logins, duration spent on the app)
This will be assessed independently, and for associations of compliance with the app and changes in alcohol consumption (primary endpoint)
Full Information
NCT ID
NCT03474328
First Posted
March 15, 2018
Last Updated
August 29, 2018
Sponsor
Royal Free Hospital NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT03474328
Brief Title
AlcoChange: An Open Label Pilot Study of Smartphone Monitoring for Alcoholic Liver Disease
Official Title
AlcoChange: An Open Label Pilot Study of Smartphone Monitoring for Alcoholic Liver Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 25, 2016 (Actual)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
November 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Royal Free Hospital NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol-Related Disorders
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment arm
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
AlcoChange
Intervention Description
Smartphone app and breathalyser
Primary Outcome Measure Information:
Title
Self-reported alcohol consumption (average/week)
Description
Assessed by time line follow back method over study period
Time Frame
3-month study period
Secondary Outcome Measure Information:
Title
Compliance with the app (no. of logins, duration spent on the app)
Description
This will be assessed independently, and for associations of compliance with the app and changes in alcohol consumption (primary endpoint)
Time Frame
3-month study period
10. Eligibility
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
presence of ARLD
age 18-70
intent to maintain abstinence
possession of compatible smartphone
Exclusion Criteria:
- inability to provide consent.
12. IPD Sharing Statement
Learn more about this trial
AlcoChange: An Open Label Pilot Study of Smartphone Monitoring for Alcoholic Liver Disease
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