Impact of knowledge of liver fibrosis on drinking behaviour

Not Applicable

Completed

• Conditions: Alcohol misuse; Mental and Behavioural Disorders; Mental and behavioural disorders due to use of alcohol

• Registration Number: ISRCTN16922410
• Lead Sponsor: ottinghamshire Healthcare NHS Foundation Trust

Brief Summary

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34732502/ (added 05/11/2021) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37448808/ (added 17/07/2023) 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/37792440/ Intervention development (added 05/10/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-26
• Study Completion: 2022-11-30
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

Work package 1 (WP1):
1. A person aged 18 years and over attending with a primary problem of alcohol misuse as defined by initial clinical assessment and had a fibroscan in past
2. Willing to participate in a focus group

Work package 2 (WP2):
1. A person aged 18 years and over attending with a primary problem of alcohol misuse as defined by initial clinical assessment.
2. A person who previously had a fibroscan
3. A person with lived experience of alcohol problems, willing to consent to the recording and public use of video recording (identified via KLIFAD PPI group, existing NRN networks or research networks at Nottingham University Hospital)
Participants from WP1 will also be invited to participate in WP2

Randomised feasibility trial (WP3):
1. A person aged 18 years and over attending with a primary problem of alcohol misuse as defined by initial clinical assessment

Exclusion Criteria

Work package 1 (WP1):
1. Other primary substance misuses even where alcohol is a factor
2. Lacks the capacity to give confirmed consent

Work package 2 (WP2):
1. Lacks the capacity to give confirmed consent

Randomised feasibility trial (WP3):
1. Other primary substance misuses even where alcohol is a factor
2. Referrals from driving offences and student referrals as these individuals are essentially not self-presenting, may have different motivation and have lower overall levels of alcohol use and so are substantially lower risk of having liver disease
3. Out of area clients at Edwin house in whom we cannot obtain follow up data due to lack of follow up availability
4. Participants unable to comply with study procedures
5. Lacks the capacity to give confirmed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Recruitment rate recorded as the number of eligible participants who consent to participate in the study by 12 months<br>2. Retention rate: number of participants who consent to participate that remain in the study until the end of follow up at 6 months <br>3. Acceptability of the intervention measured using qualitative interview at 6 months<br>4. Feasibility of outcome measures measured by analysing the feasibility of outcomes outlined as primary and secondary at baseline, 3 months and 6 months

Secondary Outcome Measures

Name	Time	Method
1. Weekly alcohol intake measured using self-reported alcohol intake at baseline, 3 months and 6 months<br>2. Alcohol misuse measured using AUDIT score at baseline, 3 months and 6 months<br>3. Severity of alcohol misuse measured using SADQ score at baseline, 3 months and 6 months