Alcohol Brief Intervention Integrated With Mobile Chat-based Support for Risky Drinkers in Emergency Departments

Not Applicable

• Conditions: Alcohol Misuse
• Interventions: Behavioral: Alcohol brief intervention; Behavioral: 12-page health warning leaflet; Behavioral: General health through IM Apps; Behavioral: Regular messages through Instant Messaging (IM); Behavioral: Real-time chat-based support through IM Apps; Behavioral: AUDIT score interpretation sheet adapted from the Department of Health of Hong Kong

• Registration Number: NCT05018624
• Lead Sponsor: The University of Hong Kong

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-08-18
• Study First Submitted QC: 2021-08-18
• Study First Posted: 2021-08-24
• Study Start: 2022-05-23
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-07
• Last Update Posted: 2022-07-11
• Primary Completion: 2024-01-05
• Study Completion: 2024-01-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 632

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	AUDIT score interpretation sheet adapted from the Department of Health of Hong Kong	Alcohol brief intervention, leaflets, regular personalized messages on ABI through IM Apps, real-time chat-based support through IM Apps
control group	Alcohol brief intervention	Alcohol brief intervention, leaflets, regular messages on general health through IM Apps
Intervention group	Alcohol brief intervention	Alcohol brief intervention, leaflets, regular personalized messages on ABI through IM Apps, real-time chat-based support through IM Apps
control group	12-page health warning leaflet	Alcohol brief intervention, leaflets, regular messages on general health through IM Apps
control group	General health through IM Apps	Alcohol brief intervention, leaflets, regular messages on general health through IM Apps
Intervention group	Regular messages through Instant Messaging (IM)	Alcohol brief intervention, leaflets, regular personalized messages on ABI through IM Apps, real-time chat-based support through IM Apps
Intervention group	12-page health warning leaflet	Alcohol brief intervention, leaflets, regular personalized messages on ABI through IM Apps, real-time chat-based support through IM Apps
Intervention group	Real-time chat-based support through IM Apps	Alcohol brief intervention, leaflets, regular personalized messages on ABI through IM Apps, real-time chat-based support through IM Apps
control group	AUDIT score interpretation sheet adapted from the Department of Health of Hong Kong	Alcohol brief intervention, leaflets, regular messages on general health through IM Apps

Primary Outcome Measures

Name	Time	Method
Amount of alcohol consumption per week (gram/week) at 12-month follow-up	12-month after baseline	Assessed by unit in gram and compare the alcohol consumption between intervention and control group at 12-month after baseline.
Compare the primary outcome using intention-to-treat (ITT), per-protocol (PP) and as-treated (AP) analysis with Compliance Average Causal Effect (CACE) analysis	6-month after baseline	To estimate large, moderate and null (same as the control) treatment effects and check whether ITT, AP and PP analysis estimates are biased compared with CACE estimates (alcohol consumption per week at 6-month follow-up)

Secondary Outcome Measures

Name	Time	Method
Amount of alcohol consumption per week (gram/week) at 6-month follow-up	6-month after baseline	Assessed by unit in gram and compare the alcohol consumption between intervention and control group at 6-month after baseline.
AUDIT scores at 6-month follow-up	6-month after baseline	Assessed by Alcohol Use Disorders Identification Test (ranged 0-40 with higher score indicating problematic alcohol use) and compare the AUDIT between intervention and control group at 6-month after baseline.
AUDIT scores at 12-month follow-up	12-month after baseline	Assessed by Alcohol Use Disorders Identification Test (ranged 0-40 with higher score indicating problematic alcohol use) and compare the AUDIT between intervention and control group at 12-month after baseline.
Number of standard drinks (10g of alcohol) per week at 6-month follow-up	6-month after baseline	Assessed by either increase or decrease in standard drinks number and compared between intervention and control group at 6-month
Number of standard drinks (10g of alcohol) per week at 12-month follow-up	12-month after baseline	Assessed by either increase or decrease in standard drinks number and compared between intervention and control group at 12-month
Episode of binge drinking in the past 30-day at 6-month follow up	at 6-month after baseline	Defined by 5 standard drink \[male\] or 4 standard drink \[female\] in one occasion for binge drinking and compare the episode of binge drinking between intervention group and control at baseline and 6-month follow-up questionnaires
Episode of binge drinking in the past 30-day at 12-month follow up	at 12-month after baseline	Defined by 5 standard drink \[male\] or 4 standard drink \[female\] in one occasion for binge drinking and compare the episode of binge drinking between intervention group and control at baseline and 12-month follow-up questionnaires
Episode of heavy drinking in the past 30-day at 6-month follow up	at 6 -month after baseline	Defined by 15 standard drink \[male\] or 8 standard drink\[female\] in a week for heavy drinking and compare the episode of heavy drinking between intervention group and control at baseline and 6-month follow-up questionnaires
Episode of heavy drinking in the past 30-day at 12-month follow up	at 12-month after baseline	Defined by 15 standard drink \[male\] or 8 standard drink \[female\] in a week for heavy drinking and compare the episode of heavy drinking between intervention group and control at baseline and 12-month follow-up questionnaires
Planned drinking measured in the coming 30-day at 6-month follow up	at 6-month after baseline	Compare the number of planned drinking (yes or no) between intervention group and control group at baseline and 6-month follow-up questionnaires
Planned drinking measured in the coming 30-day at 12-month follow up	at 12-month after baseline	Compare the number of planned drinking (yes or no) between intervention group and control group at baseline and 12-month follow-up questionnaires
Alcohol Problems Scale at 6-month follow-up	at 6-month after baseline	The 14-item measure of alcohol-related personal, social, sexual, and legal problems (eg, being physically aggressive toward someone while under the influence of alcohol).The score will be compared between intervention group and control group at baseline and 6-month follow-up questionnaires
Alcohol Problems Scale at 12-month follow-up	at 12- month after baseline	The 14-item measure of alcohol-related personal, social, sexual, and legal problems (eg, being physically aggressive toward someone while under the influence of alcohol).The score will be compared between intervention group and control group at baseline and 12-month follow-up questionnaires
Subgroup analysis of baseline intention to quit/reduce drinking	at 12- month after baseline	Subgroup analysis to check whether the intervention is more effective with participants with intention to quit/reduce drinking on outcomes
Content analysis of IM Apps conversation using alcohol BCT taxonomy	at 12- month after baseline	The conversations between the participants and the nurse will be analyzed and categorized into different sub-type of BCT taxonomy
Patient Health Questionnaire 4-item (PHQ-4) at 6-month	at 6-month after baseline	Total score is determined by adding together the scores of each of the 4 items. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12).; Total score ≥3 for first 2 questions suggests anxiety. Total score ≥3 for last 2 questions suggests depression. The score will be compared between intervention group and control group at baseline and 6-month follow-up questionnaires
Patient Health Questionnaire 4-item (PHQ-4) at 12-month	at 12-month after baseline	Total score is determined by adding together the scores of each of the 4 items. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12).; Total score ≥3 for first 2 questions suggests anxiety. Total score ≥3 for last 2 questions suggests depression. The score will be compared between intervention group and control group at baseline and 12-month follow-up questionnaires
Perceived Stress Scale 4-item (PSS-4) at 6-month	at 6-month after baseline	Subjects' responses are measured on a five-point scale (0 = never, 1 = almost never, 2; =sometimes, 3 = fairly often, 4 = very often). Scoring: PSS-4 scores are obtained by summing across all four items. Scoring items 2 and 3 require reverse coding. This involves assigning the opposite score. For example, a score of 0=4, 1=3, 2=2, 3=1, and 4=0. The higher the score, the more perceived stress.; The score will be compared between intervention group and control group at baseline and 6-month follow-up questionnaires
Perceived Stress Scale 4-item (PSS-4) at 12-month	at 12-month after baseline	Subjects' responses are measured on a five-point scale (0 = never, 1 = almost never, 2; =sometimes, 3 = fairly often, 4 = very often). Scoring: PSS-4 scores are obtained by summing across all four items. Scoring items 2 and 3 require reverse coding. This involves assigning the opposite score. For example, a score of 0=4, 1=3, 2=2, 3=1, and 4=0. The higher the score, the more perceived stress.; The score will be compared between intervention group and control group at baseline and 12-month follow-up questionnaires
Perceived usefulness of IM app intervention at 12-month	at 12-month after baseline	Score ranges from 0 to 10 with higher score indicates a higher level of usefulness of our intervention.
Intention to continue using IM app intervention at 12-month	at 12-month after baseline	Ask for intention to use (yes/no) IM app intervention to reduce/quit drinking at 12-month
Self-efficacy to reduce/quit drinking at 6-month	at 6-month after baseline	Perceived difficulty, confidence and importance of quitting/reducing to drink will be asked.; Score ranges from 0 to 10 with higher score indicates a high level. The score will be compared between intervention group and control group at baseline and 6-month follow-up questionnaires
Self-efficacy to reduce/quit drinking at 12-month	at 12-month after baseline	Perceived difficulty, confidence and importance of quitting/reducing to drink will be asked.; Score ranges from 0 to 10 with higher score indicates a high level. The score will be compared between intervention group and control group at baseline and 12-month follow-up questionnaires
Re-attendance of AED at 6-month	at 6-month after baseline	Ask for attendance of AED (yes/no) in the past 3-month at 6-month
Re-attendance of AED at 12-month	at 12-month after baseline	Ask for attendance of AED (yes/no) in the past 3-month at 12-month
Health status of participants at 6-month	at 6-month after baseline	Measured by EQ-5D-5L. Comprises five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN /DISCOMFORT and ANXIETY / DEPRESSION), each dimension has five response levels:no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. The participant is asked to indicate his/her health state by checking the box next to the most appropriate response level. Responses are coded as single-digit numbers expressing the severity level selected in each dimension. Extreme problem is coded as 5, severe problem is coded as 4, moderate is coded as 3, slight problem is coded as 2 and no problem is coded as 1.
Health status of participants at 12-month	at 12-month after baseline	Measured by EQ-5D-5L. Comprises five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN /DISCOMFORT and ANXIETY / DEPRESSION), each dimension has five response levels:no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. The participant is asked to indicate his/her health state by checking the box next to the most appropriate response level. Responses are coded as single-digit numbers expressing the severity level selected in each dimension. Extreme problem is coded as 5, severe problem is coded as 4, moderate is coded as 3, slight problem is coded as 2 and no problem is coded as 1.
Current health of participants at 6-month	at 6-month after baseline	Measured by EQ VAS. Participant is asked to rate his/her health on a vertical visual analogue scale. The scale is numbered from 0-100.100 means the best health, 0 is the worst. Participant will put a "cross" on the scale to indicate his/her current health.
Current health of participants at 12-month	at 12-month after baseline	Measured by EQ VAS. Participant is asked to rate his/her health on a vertical visual analogue scale. The scale is numbered from 0-100.100 means the best health, 0 is the worst. Participant will put a "cross" on the scale to indicate his/her current health.

Trial Locations

Locations (1)

School of Nursing, The University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong