Nurse-led Alcohol Brief Intervention Plus Mobile Personalized Chat-based Support on Reducing Alcohol Use in University Students

Study Overview
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Brief Summary
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This study aims to assess the effect of personalized support using instant messaging application on alcohol drinking reduction in university students proactively recruited from universities in Hong Kong.

Detailed Description
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The government has promoted Hong Kong as the Asian's wine hub with zero alcohol tax (ethanol ≤30%) since 2008, which causes dramatic increases in alcohol drinking and binge drinking rates. Alcohol use in youth is the leading cause of disability adjusted life-years loss. Most adult drinkers start drinking at age 18-21. Evidence shows that alcohol brief intervention (ABI) is effective reducing hazardous and harmful alcohol use in university students. The proposed trial aims to enhance the ABI by incorporating information communication technologies (ICTs) such as instant messaging (IM) Apps (e.g. WhatsApp and WeChat) to provide personalized, real-time chat-based support led by nurses. The aims of study are as follows: To determine the main effect of the Intervention vs. Control group on alcohol consumption per week at 6-month (Primary) To assess the effects on alcohol consumption per week at 12-month, AUDIT scores at 6 and 12-month, perceived usefulness of IM app at 12-month, intention to use IM app to reduce/quit drinking at 12-month, number of standard drinks, episode of binge drinking, episode of heavy drinking, planned drinking, Academic Role Expectation and Alcohol Scale, Alcohol Problems Scale, Patient Health Questionnaire 4-item, Perceived Stress Scale 4-item, Covid-19 related drinking behavioral changes, and self-efficacy to reduce/quit drinking at 6-month and 12-month To identify mediators between intervention and outcomes to inform the potential mechanisms To qualitatively explore experience on the interventions for reducing alcohol use and related harms

Official Title
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Nurse-led Alcohol Brief Intervention Plus Mobile Personalized Chat-based Support on Reducing Alcohol Use in University Students: a Pragmatic Randomized Controlled Trial

Conditions
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Alcohol Misuse

Intervention / Treatment
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* Behavioral: Alcohol brief intervention
* Behavioral: 12-page health warning leaflet
* Behavioral: Regular messages through Instant Messaging (IM)
* Behavioral: Real-time chat-based support through IM Apps
* Behavioral: General health through SMS
* Behavioral: AUDIT score interpretation sheet adapted from the Department of Health of Hong Kong


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Student aged ≥18 years from local universities in Hong Kong Able to read and communicate in Chinese (Cantonese or Mandarin) Likely to stay in Hong Kong for most of the time in the next 12 months Using IM Apps (WhatsApp or WeChat) installed on a smartphone Baseline AUDIT screening score ≥8 Exclusion Criteria: Having a history of psychiatric/psychological disease or currently on regular psychotropic medications Currently participating in treatments or programmes on reducing alcohol use

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Alcohol brief intervention, leaflets, regular personalized messages on ABI through IM Apps, real-time chat-based support through IM Apps | Behavioral: Alcohol brief intervention<br>* 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<br>Behavioral: 12-page health warning leaflet<br>* 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.<br>Behavioral: Regular messages through Instant Messaging (IM)<br>* 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.<br>Behavioral: Real-time chat-based support through IM Apps<br>* 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.<br>Behavioral: AUDIT score interpretation sheet adapted from the Department of Health of Hong Kong<br>* 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<br>|
| Active Comparator: control group<br>Alcohol brief intervention, leaflets, regular messages on general health through SMS | Behavioral: Alcohol brief intervention<br>* 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<br>Behavioral: 12-page health warning leaflet<br>* 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.<br>Behavioral: General health through SMS<br>* After baseline, they will receive regular e-message through SMS with similar frequency to Intervention group with content on general health and the reminding the importance of participating in the follow-up surveys.<br>Behavioral: AUDIT score interpretation sheet adapted from the Department of Health of Hong Kong<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Academic Role Expectation and Alcohol Scale at 6-month follow-up | The four items in this scale addressed the number of times the student had been 'late to class', 'missed class', was 'unable to concentrate' and 'failed to complete assignment' (score range 0-16). The responses included 'not at all', 'once', 'twice', 'three times' and 'four times or more'. The score will be compared between intervention group and control group at baseline and 6-month follow-up questionnaires | at 6-month after baseline | 
| Academic Role Expectation and Alcohol Scale at 12-month follow-up | The four items in this scale addressed the number of times the student had been 'late to class', 'missed class', was 'unable to concentrate' and 'failed to complete assignment' (score range 0-16). The responses included 'not at all', 'once', 'twice', 'three times' and 'four times or more'. The score will be compared between intervention group and control group at baseline and 12-month follow-up questionnaires | at 12-month after baseline | 
| 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 | 
| 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 | 
| Mediation analysis of variables at 6-month on weekly amount of alcohol consumption at 12-month | Mediation analysis of 6-month factors (knowledge of alcohol drinking, perception of alcohol drinking, intention to quit drinking, mental health) on weekly amount of alcohol consumption at 12-month | at 12- month after baseline | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Covid-19 related drinking behavioral changes at baseline | Assessed by stop drinking, increase (+50%), slight increase, decrease (-50%), slight decrease or no change of drinking after the start of pandemic | at baseline | 
| Covid-19 related drinking behavioral changes at 6-month | Assessed by stop drinking, increase (+50%), slight increase, decrease (-50%), slight decrease or no change of drinking after the start of pandemic. The changes will be compared between the intervention group and control group at 6-month | at 6-month | 
| Covid-19 related drinking behavioral changes at 12-month | Assessed by stop drinking, increase (+50%), slight increase, decrease (-50%), slight decrease or no change of drinking after the start of pandemic. The changes will be compared between the intervention group and control group at 12-month | at 12-month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chat-based IM, alcohol brief intervention, alcohol misuse, university students