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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
Royal Free Hospital NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alcohol-Related Disorders

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Does not accept healthy volunteers

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

    First Posted
    March 15, 2018
    Last Updated
    August 29, 2018
    Sponsor
    Royal Free Hospital NHS Foundation Trust
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    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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