Clinical trial NCT05018624: Alcohol Brief Intervention Integrated With Mobile Chat-based Support for Risky Drinkers in Emergency Departments
Official title: Alcohol Brief Intervention Integrated With Mobile Chat-based Support for Risky Drinkers in Emergency Departments: a Pragmatic Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alcohol Misuse
Keywords: Chat-based IM
Alcohol brief intervention
AED
AUDIT
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 632
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to assess the effectiveness of chat-based intervention on reducing risky alcohol consumption to inform clinical practice for providing ABI to risky drinkers attending AED in Hong Kong.

Detailed description: Alcohol use is a major risk factor for non-communicable diseases and 6th leading cause of death and disability-adjusted life years. The prevalence of alcohol consumption has increased since 2008 after introduction of zero tax on alcohol with strength \<30% (e.g., wine and beer) and due to promoting the city as Asia's wine hub. ABI reduced alcohol intake by about 20g/week at 12-month follow-up in primary healthcare populations. Given the relatively low prevalence of risky alcohol drinkers in Hong Kong, testing ABI in clinics may face difficulties in recruitment. Alcohol use is associated with problems such as injury and violence requiring accident and emergency department (AED) services, thus AEDs in Hong Kong are more feasible places to recruit subjects for delivering ABI.

Primary hypothesis: The Intervention group has significantly larger reduction of weekly alcohol consumption compared with the Control group at 12-month follow-up

Secondary hypotheses: Compared with the Control group, the Intervention group has lower AUDIT scores, fewer episodes of heavy/binge drinking, lower re-attendence at AED and reduced alcohol-related harms at 6-month and 12-month follow-up.

Eligibility criteria: Inclusion Criteria:

* HK resident able to read/communicate in Cantonese/Putonghua. This may exclude potential subjects from other countries with higher alcohol consumption than local Chinese, but quality of the chat-based intervention is important for the research hypothesis, and it will not be feasible to recruit other language speakers (e.g., English) in the present study.
* Aged ≥18 with proficiency in using IM Apps (e.g., WhatsApp, WeChat). Those aged \<18 are excluded as other studies suggest they have different patterns of alcohol drinking and reduction from adult drinkers.

Exclusion Criteria:

* Those unable to understand or receive face-to-face ABI due to severe traumatic injury, unconscious, or drunk patients unable to follow commands
* Anticipated to be admitted to in-patient department for \>1 week, which will interfere with the chat-based intervention
* Having psychiatric/psychological diseases or receiving regular psychotropic medication
* Participating in other alcohol reduction or abstinence programmes

Primary outcomes:
measure: Amount of alcohol consumption per week (gram/week) at 12-month follow-up
timeFrame: 12-month after baseline
measure: Compare the primary outcome using intention-to-treat (ITT), per-protocol (PP) and as-treated (AP) analysis with Compliance Average Causal Effect (CACE) analysis
timeFrame: 6-month after baseline
Secondary outcomes:
measure: Amount of alcohol consumption per week (gram/week) at 6-month follow-up
timeFrame: 6-month after baseline
measure: AUDIT scores at 6-month follow-up
timeFrame: 6-month after baseline
measure: AUDIT scores at 12-month follow-up
timeFrame: 12-month after baseline
measure: Number of standard drinks (10g of alcohol) per week at 6-month follow-up
timeFrame: 6-month after baseline
measure: Number of standard drinks (10g of alcohol) per week at 12-month follow-up
timeFrame: 12-month after baseline
measure: Episode of binge drinking in the past 30-day at 6-month follow up
timeFrame: at 6-month after baseline
measure: Episode of binge drinking in the past 30-day at 12-month follow up
timeFrame: at 12-month after baseline
measure: Episode of heavy drinking in the past 30-day at 6-month follow up
timeFrame: at 6 -month after baseline
measure: Episode of heavy drinking in the past 30-day at 12-month follow up
timeFrame: at 12-month after baseline
measure: Planned drinking measured in the coming 30-day at 6-month follow up
timeFrame: at 6-month after baseline
measure: Planned drinking measured in the coming 30-day at 12-month follow up
timeFrame: at 12-month after baseline
measure: Alcohol Problems Scale at 6-month follow-up
timeFrame: at 6-month after baseline
measure: Alcohol Problems Scale at 12-month follow-up
timeFrame: at 12- month after baseline
measure: Subgroup analysis of baseline intention to quit/reduce drinking
timeFrame: at 12- month after baseline
measure: Content analysis of IM Apps conversation using alcohol BCT taxonomy
timeFrame: at 12- month after baseline
measure: Patient Health Questionnaire 4-item (PHQ-4) at 6-month
timeFrame: at 6-month after baseline
measure: Patient Health Questionnaire 4-item (PHQ-4) at 12-month
timeFrame: at 12-month after baseline
measure: Perceived Stress Scale 4-item (PSS-4) at 6-month
timeFrame: at 6-month after baseline
measure: Perceived Stress Scale 4-item (PSS-4) at 12-month
timeFrame: at 12-month after baseline
measure: Perceived usefulness of IM app intervention at 12-month
timeFrame: at 12-month after baseline
measure: Intention to continue using IM app intervention at 12-month
timeFrame: at 12-month after baseline
measure: Self-efficacy to reduce/quit drinking at 6-month
timeFrame: at 6-month after baseline
measure: Self-efficacy to reduce/quit drinking at 12-month
timeFrame: at 12-month after baseline
measure: Re-attendance of AED at 6-month
timeFrame: at 6-month after baseline
measure: Re-attendance of AED at 12-month
timeFrame: at 12-month after baseline
measure: Health status of participants at 6-month
timeFrame: at 6-month after baseline
measure: Health status of participants at 12-month
timeFrame: at 12-month after baseline
measure: Current health of participants at 6-month
timeFrame: at 6-month after baseline
measure: Current health of participants at 12-month
timeFrame: at 12-month after baseline
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Nursing, The University of Hong Kong
Study officials:
References: