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

Alcohol Misuse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04025151
• Other study ID #: Chat-based ABI (UniStudents)
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2020
• Est. completion date: November 30, 2022

Study information

• Verified date: September 2021
• 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 effect of personalized support using instant messaging application on alcohol drinking reduction in university students proactively recruited from universities in Hong Kong.

Description:

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:

1. To determine the main effect of the Intervention vs. Control group on alcohol consumption per week at 6-month (Primary)

2. 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

3. To identify mediators between intervention and outcomes to inform the potential mechanisms

4. To qualitatively explore experience on the interventions for reducing alcohol use and related harms

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 770
• Est. completion date: November 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Misuse

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 SMS
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.
• 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, 

References & Publications (18)

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Kypri K, Hallett J, Howat P, McManus A, Maycock B, Bowe S, Horton NJ. Randomized controlled trial of proactive web-based alcohol screening and brief intervention for university students. Arch Intern Med. 2009 Sep 14;169(16):1508-14. doi: 10.1001/archinternmed.2009.249. — View Citation

Kypri K, Vater T, Bowe SJ, Saunders JB, Cunningham JA, Horton NJ, McCambridge J. Web-based alcohol screening and brief intervention for university students: a randomized trial. JAMA. 2014 Mar 26;311(12):1218-24. doi: 10.1001/jama.2014.2138. — View Citation

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Luk TT, Li WHC, Cheung DYT, Wong SW, Kwong ACS, Lai VWY, Chan SS, Lam TH, Wang MP. Chat-based instant messaging support combined with brief smoking cessation interventions for Chinese community smokers in Hong Kong: Rationale and study protocol for a pragmatic, cluster-randomized controlled trial. Contemp Clin Trials. 2019 Feb;77:70-75. doi: 10.1016/j.cct.2018.12.013. Epub 2018 Dec 26. — View Citation

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Wang MP, Ho SY, Lam TH. Underage alcohol drinking and medical services use in Hong Kong: a cross-sectional study. BMJ Open. 2013 May 28;3(5). pii: e002740. doi: 10.1136/bmjopen-2013-002740. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
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 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
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	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
Secondary	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
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	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
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	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
Secondary	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
Secondary	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