Alcohol misuse Mental and Behavioural Disorders Mental and behavioural disorders due to use of alcohol
Conditions
Interventions
Trial Design
The trial has the following work packages (WP):
1. WP1: Establish a standardised script framework for fibroscan operators to deliver liver disease-specific advice to eligible participants
Sponsors
Nottinghamshire Healthcare NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Recruitment rate recorded as the number of eligible participants who consent to participate in the study by 12 months 2. Retention rate: number of participants who consent to participate that remain in the study until the end of follow up at 6 months 3. Acceptability of the intervention measured using qualitative interview at 6 months 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
| Measure | Time frame |
|---|---|
| 1. Weekly alcohol intake measured using self-reported alcohol intake at baseline, 3 months and 6 months 2. Alcohol misuse measured using AUDIT score at baseline, 3 months and 6 months 3. Severity of alcohol misuse measured using SADQ score at baseline, 3 months and 6 months | — |
Countries
England, United Kingdom
Outcome results
None listed