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

Alcohol Misuse Clinical Trial

Official title:

Alcohol Brief Intervention Integrated With Mobile Chat-based Support for Risky Drinkers in Emergency Departments: a Pragmatic Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05018624
• Other study ID #: Chat-based ABI (AED)
• Status: Recruiting
• Phase: N/A
• Start date: May 23, 2022
• Est. completion date: January 5, 2024

Study information

• Verified date: July 2022
• Source: The University of Hong Kong
• Contact: Siu Long Chau, PhD
• Phone: +852-39176981
• Email: h1357885[@]connect.hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 632
• Est. completion date: January 5, 2024
• Est. primary completion date: January 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Misuse
• Emergencies

Intervention

Behavioral:
• Alcohol brief intervention
At baseline, subjects will receive face-to-face or online alcohol brief intervention developed based on the guideline by the World Health Organisation in 5-10 minutes
• 12-page health warning leaflet
Nurses will provide information about the consequences of drinking using a 12-page health warning booklet. Benefits of reducing and quit drinking will be emphasized by focusing on improving their perception towards the impacts on health, social problems, risky behaviors, academic performance and financial issues.
• Regular messages through Instant Messaging (IM)
A total of 26 e-messages will be scheduled: once daily for the first week, 3 time/week for subsequent 4 weeks and 1 time/week for the remaining 7 weeks. The frequency will be adjusted according to IM Apps conversation and subject's requests.
• Real-time chat-based support through IM Apps
The chat-based IM support is the extension of baseline ABI and regular e-messages, which aims to provide real-time behavioral and psychosocial support to reduce or quit drinking. It will be personalized according to the subjects' characteristics (gender, drinking pattern and alcoholic drinks preferences), intention to drink and specific questions regarding drinking. Through real-time chatting (text and/or voice), drinkers can acquire information on consequences of drinking and gain social support immediately to reduce intention to drink and alcohol consumption.
• General health through IM Apps
After baseline, they will receive regular e-message through IM Apps with similar frequency to Intervention group with content on general health and the reminding the importance of participating in the follow-up surveys.
• AUDIT score interpretation sheet adapted from the Department of Health of Hong Kong
a diagram explaining drinking behaviour and potential health risks, definitions of "alcohol unit" and "binge drinking", and advise on limiting daily drinking to 2 alcohol units for men and 1 unit for women

Locations

Country	Name	City	State
Hong Kong	School of Nursing, The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of alcohol consumption per week (gram/week) at 12-month follow-up	Assessed by unit in gram and compare the alcohol consumption between intervention and control group at 12-month after baseline.	12-month after baseline
Primary	Compare the primary outcome using intention-to-treat (ITT), per-protocol (PP) and as-treated (AP) analysis with Compliance Average Causal Effect (CACE) analysis	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)	6-month after baseline
Secondary	Amount of alcohol consumption per week (gram/week) at 6-month follow-up	Assessed by unit in gram and compare the alcohol consumption between intervention and control group at 6-month after baseline.	6-month after baseline
Secondary	AUDIT scores at 6-month follow-up	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.	6-month after baseline
Secondary	AUDIT scores at 12-month follow-up	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.	12-month after baseline
Secondary	Number of standard drinks (10g of alcohol) per week at 6-month follow-up	Assessed by either increase or decrease in standard drinks number and compared between intervention and control group at 6-month	6-month after baseline
Secondary	Number of standard drinks (10g of alcohol) per week at 12-month follow-up	Assessed by either increase or decrease in standard drinks number and compared between intervention and control group at 12-month	12-month after baseline
Secondary	Episode of binge drinking in the past 30-day at 6-month follow up	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	at 6-month after baseline
Secondary	Episode of binge drinking in the past 30-day at 12-month follow up	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	at 12-month after baseline
Secondary	Episode of heavy drinking in the past 30-day at 6-month follow up	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	at 6 -month after baseline
Secondary	Episode of heavy drinking in the past 30-day at 12-month follow up	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	at 12-month after baseline
Secondary	Planned drinking measured in the coming 30-day at 6-month follow up	Compare the number of planned drinking (yes or no) between intervention group and control group at baseline and 6-month follow-up questionnaires	at 6-month after baseline
Secondary	Planned drinking measured in the coming 30-day at 12-month follow up	Compare the number of planned drinking (yes or no) between intervention group and control group at baseline and 12-month follow-up questionnaires	at 12-month after baseline
Secondary	Alcohol Problems Scale at 6-month follow-up	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	at 6-month after baseline
Secondary	Alcohol Problems Scale at 12-month follow-up	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	at 12- month after baseline
Secondary	Subgroup analysis of baseline intention to quit/reduce drinking	Subgroup analysis to check whether the intervention is more effective with participants with intention to quit/reduce drinking on outcomes	at 12- month after baseline
Secondary	Content analysis of IM Apps conversation using alcohol BCT taxonomy	The conversations between the participants and the nurse will be analyzed and categorized into different sub-type of BCT taxonomy	at 12- month after baseline
Secondary	Patient Health Questionnaire 4-item (PHQ-4) at 6-month	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	at 6-month after baseline
Secondary	Patient Health Questionnaire 4-item (PHQ-4) at 12-month	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	at 12-month after baseline
Secondary	Perceived Stress Scale 4-item (PSS-4) at 6-month	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	at 6-month after baseline
Secondary	Perceived Stress Scale 4-item (PSS-4) at 12-month	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	at 12-month after baseline
Secondary	Perceived usefulness of IM app intervention at 12-month	Score ranges from 0 to 10 with higher score indicates a higher level of usefulness of our intervention.	at 12-month after baseline
Secondary	Intention to continue using IM app intervention at 12-month	Ask for intention to use (yes/no) IM app intervention to reduce/quit drinking at 12-month	at 12-month after baseline
Secondary	Self-efficacy to reduce/quit drinking at 6-month	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	at 6-month after baseline
Secondary	Self-efficacy to reduce/quit drinking at 12-month	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	at 12-month after baseline
Secondary	Re-attendance of AED at 6-month	Ask for attendance of AED (yes/no) in the past 3-month at 6-month	at 6-month after baseline
Secondary	Re-attendance of AED at 12-month	Ask for attendance of AED (yes/no) in the past 3-month at 12-month	at 12-month after baseline
Secondary	Health status of participants at 6-month	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.	at 6-month after baseline
Secondary	Health status of participants at 12-month	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.	at 12-month after baseline
Secondary	Current health of participants at 6-month	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.	at 6-month after baseline
Secondary	Current health of participants at 12-month	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.	at 12-month after baseline