Alcohol-related liver disease Digestive System Alcoholic liver disease
Conditions
Interventions
Current intervention as of 03/03/2022:
The AlcoChange trial is a multicentre, 2 arm individually randomised controlled trial comparing usual care against usual care plus the AlcoChange intervention (b
Sponsors
University of Southampton
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 02/03/2022: 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 1 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 Previous participant inclusion criteria: 1. Adults aged 18 years or older 2. Admission with ARLD (alcoholic hepatitis or cirrhosis – diagnosed clinically or by imaging/biopsy), alcohol use within 1 month of admission, referred to alcohol care team 3. Access to appropriate smartphone 4. Willing and able to give written informed consent 5. Sufficient English to understand the instructions for using the AlcoChange device
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 02/03/2022: 1. Taking part in another interventional study 2. Referred for palliative care 3. Referred for inpatient alcohol rehabilitation Previous participant exclusion criteria: 1. Taking part in another interventional study 2. Referred for palliative care 3. Referred to rehabilitation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who are abstinent or reduced drinking to low-risk levels (<14 units/week), measured using the Timeline Follow Back method (TLFB) (data collected for the previous 28 days) at 180 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 03/03/2022: 1. Self-reported alcohol use over the previous 28 days, using the Timeline Followback (TLFB) method, at baseline, 90 days, and 180 days 2. Self-reported alcohol use over the previous 14 days, calculated from TLFB data,at baseline, 90 days, and 180 days 3. Proportion of patients in the intervention condition achieving abstinence in the previous 28 days compared to control condition, calculated from TLFB data, at baseline, 90 days, and 180 days 4. Drink-free days over the previous 90 days, reported by the patient, at baseline, 90 days, and 180 days 5. Heavy drinking days over the previous 28 days, calculated from TLFB data and defined as =60 g alcohol/day for males and =40 g/day for females, at baseline, 90 days, and 180 days 6. App usage data (for participants allocated to the intervention arm), at 90 days and 180 days 7. Health-related quality of life (HRQoL), measured by EuroQoL (EQ-5D 5L) questionnaire, at baseline, 90 days, and 180 days 8. Quality-adjusted life years (QALYs), calculated from the EQ-5D-5L, at baseline, 90 days, and 180 days 9. Health care resource use and costs, calculated using the resource use questionnaire, at baseline, 90 days, and 180 days 10. Hospital admissions, using medical notes check, at 90 days and 180 days 11. Loss of capacity, determined by clinician decision, at 90 days and 180 days 12. Death/rehospitalisation composite, using medical notes check, at 90 days and 180 days. Previous secondary outcome measures: 1. Self-reported alcohol use over the previous 28 days measured using TLFB at 90 and 180 days 2. Self-reported drink-free days over the previous 90 days measured using patient questionnaire at 90 and 180 days 3. Heavy drinking days over the previous 28 days, calculated from the TLFB and defined as =60 g alcohol/day for males and =40 g/day for females; at 90 and 180 days 4. App usage data (for participants recruited under the intervention condition) at 90 and 180 days 5. L | — |
Countries
England, United Kingdom
Outcome results
None listed