AlcoChange

Title

Real world implementation of AlcoChange: a smartphone digital therapeutic to improve outcomes from alcohol-related liver disease.

Description

AlcoChange is a randomised controlled trial (RCT) evaluating whether the AlcoChange intervention (breathalyser and app) can help patients with alcohol-related liver disease (ArLD) reduce their alcohol use. For a more general overview of the trial, please visit the Alcochange website .

Outcomes

Primary outcome

Proportion of patients in the intervention arm, compared to the control arm, abstinent or reduced drinking to low-risk levels (<14 units/wk) at 180 days (Timeline Follow Back method, TLFB)

Secondary outcomes

At 90 days:

• self-reported alcohol use over the previous 28 days (TLFB),
• self-reported alcohol use over the previous 14 days (calculated from TLFB data)
• self-reported drink-free days over the previous 90 days,
• heavy drinking days over the previous 28 days, calculated from the TLFB and defined as ≥ 60g alcohol/day for males and ≥ 40g/day for females
• app usage data,
• health-related quality of life (HRQoL), measured by EuroQoL (EQ-5D 5L) questionnaire,
• quality-adjusted life years (QALYs),
• health care resource use and costs,
• hospital admissions,
• loss of capacity
• death/rehospitalisation composite.

At 180 days:

• self-reported alcohol use over the previous 28 days (TLFB)
• self-reported alcohol use over the previous 14 days (calculated from TLFB data)
• self-reported drink-free days over the previous 90 days,
• heavy drinking days over the previous 28 days, calculated from the TLFB and defined as ≥ 60g alcohol/day for males and ≥ 40g/day for females
• app usage data,
• MELD score,
• UKELD score,
• Child-Pugh score,
• health-related quality of life (HRQoL), measured by EuroQoL (EQ-5D 5L) questionnaire,
• quality-adjusted life years (QALYs),
• health care resource use and costs,
• net monetary benefits (cost-effectiveness),
• hospital admissions,
• loss of capacity,
• death/rehospitalisation composite.

Exploratory analyses

• At baseline and 180 days: saliva sample for microbiome analysis (correlated with severity of ArLD)
• At 180 days: urine sample for ethylglucoronide (alcohol metabolite) and other exploratory metabolic markers of ArLD

Trial Design

AlcoChange is a multicentre, 2 arm individually randomised controlled trial comparing usual care against usual care plus the AlcoChange intervention in patients with ArLD.

The treatment allocation ratio will be 1:1. We aim to recruit 400 patients from up to 18 UK hospitals over 12 months.

Participants will be asked to attend two clinic visits over their 6 month involvement (at baseline and 180 days) and complete one telephone questionnaire with a member of the study team (at 90 days).

Trial Status

Open to recruitment.

Population

Inclusion criteria:

1. Adults aged 18 years or older
2. Non-elective admission with ArLD (alcoholic hepatitis or cirrhosis – diagnosed clinically or by imaging/biopsy)
3. Alcohol use within one month of admission, and referred to alcohol care team
4. Access to appropriate smart phone
5. Willing and able to give written informed consent
6. Sufficient English to understand the instructions for using the AlcoChange device

Exclusion criteria:

1. Taking part in another interventional study
2. Referred for palliative care
3. Referred for in-patient alcohol rehabilitation

Data protection and privacy notices for the trial

AlcoChange DTx - Privacy Policy v1.2

AlcoChange DTx - Terms and Conditions v1.2

University of Southampton data protection policy governing the use of personal data by the University can be found here .

University of Southampton privacy notice for research participants provides more information on how the University of Southampton collects and uses your personal data when you take part in one of the University’s research projects and can be found here .

University College London’s data protection policy can be found on its website .

University College London’s privacy notice for participants and researchers in health and care research studies is available here .

This trial is funded by a National Institute for Health Research i4i grant (award reference no. NIHR201002)