- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04025151
Nurse-led Alcohol Brief Intervention Plus Mobile Personalized Chat-based Support on Reducing Alcohol Use in University Students
Nurse-led Alcohol Brief Intervention Plus Mobile Personalized Chat-based Support on Reducing Alcohol Use in University Students: a Pragmatic Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
- 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: AUDIT score interpretation sheet adapted from the Department of Health of Hong Kong
- Behavioral: General health through SMS
Detailed 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:
- 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
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Hong Kong, Hong Kong, 000000
- Recruiting
- School of Nursing, The University of Hong Kong
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention group
Alcohol brief intervention, leaflets, regular personalized messages on ABI through IM Apps, real-time chat-based support through IM Apps
|
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
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.
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.
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.
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
|
ACTIVE_COMPARATOR: control group
Alcohol brief intervention, leaflets, regular messages on general health through SMS
|
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
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.
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
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Amount of alcohol consumption per week (gram/week) at 6-month follow-up
Time Frame: 6-month after baseline
|
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
Time Frame: 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)
|
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
Time Frame: 12-month after baseline
|
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
Time Frame: 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.
|
6-month after baseline
|
AUDIT scores at 12-month follow-up
Time Frame: 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.
|
12-month after baseline
|
Number of standard drinks (10g of alcohol) per week at 6-month follow-up
Time Frame: 6-month after baseline
|
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
Time Frame: 12-month after baseline
|
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
Time Frame: 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
|
at 6-month after baseline
|
Episode of binge drinking in the past 30-day at 12-month follow up
Time Frame: 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
|
at 12-month after baseline
|
Episode of heavy drinking in the past 30-day at 6-month follow up
Time Frame: 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
|
at 6 -month after baseline
|
Episode of heavy drinking in the past 30-day at 12-month follow up
Time Frame: 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
|
at 12-month after baseline
|
Planned drinking measured in the coming 30-day at 6-month follow up
Time Frame: 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
|
at 6-month after baseline
|
Planned drinking measured in the coming 30-day at 12-month follow up
Time Frame: 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
|
at 12-month after baseline
|
Academic Role Expectation and Alcohol Scale at 6-month follow-up
Time Frame: at 6-month after baseline
|
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
Time Frame: at 12-month after baseline
|
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
Time Frame: 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
|
at 6-month after baseline
|
Alcohol Problems Scale at 12-month follow-up
Time Frame: 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
|
at 12- month after baseline
|
Mediation analysis of variables at 6-month on weekly amount of alcohol consumption at 12-month
Time Frame: at 12- month after baseline
|
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
Time Frame: 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
|
at 12- month after baseline
|
Content analysis of IM Apps conversation using alcohol BCT taxonomy
Time Frame: 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
|
at 12- month after baseline
|
Patient Health Questionnaire 4-item (PHQ-4) at 6-month
Time Frame: 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 |
at 6-month after baseline
|
Patient Health Questionnaire 4-item (PHQ-4) at 12-month
Time Frame: 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 |
at 12-month after baseline
|
Perceived Stress Scale 4-item (PSS-4) at 6-month
Time Frame: 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 |
at 6-month after baseline
|
Perceived Stress Scale 4-item (PSS-4) at 12-month
Time Frame: 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 |
at 12-month after baseline
|
Perceived usefulness of IM app intervention at 12-month
Time Frame: at 12-month after baseline
|
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
Time Frame: at 12-month after baseline
|
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
Time Frame: 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 |
at 6-month after baseline
|
Self-efficacy to reduce/quit drinking at 12-month
Time Frame: 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 |
at 12-month after baseline
|
Covid-19 related drinking behavioral changes at baseline
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Eysenbach G; CONSORT-EHEALTH Group. CONSORT-EHEALTH: improving and standardizing evaluation reports of Web-based and mobile health interventions. J Med Internet Res. 2011 Dec 31;13(4):e126. doi: 10.2196/jmir.1923.
- 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.
- Thomas GN, Wang MP, Ho SY, Mak KH, Cheng KK, Lam TH. Adverse lifestyle leads to an annual excess of 2 million deaths in China. PLoS One. 2014 Feb 26;9(2):e89650. doi: 10.1371/journal.pone.0089650. eCollection 2014.
- Gore FM, Bloem PJ, Patton GC, Ferguson J, Joseph V, Coffey C, Sawyer SM, Mathers CD. Global burden of disease in young people aged 10-24 years: a systematic analysis. Lancet. 2011 Jun 18;377(9783):2093-102. doi: 10.1016/S0140-6736(11)60512-6. Epub 2011 Jun 7. Erratum In: Lancet. 2011 Aug 6;378(9790):486.
- 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):e002740. doi: 10.1136/bmjopen-2013-002740.
- Huang R, Ho SY, Wang MP, Lo WS, Lam TH. Reported alcohol drinking and mental health problems in Hong Kong Chinese adolescents. Drug Alcohol Depend. 2016 Jul 1;164:47-54. doi: 10.1016/j.drugalcdep.2016.04.028. Epub 2016 Apr 25.
- Department of Health. Report of population health survey 2014/15, Hong Kong SAR; 2018. Retrived at 24 Oct 2018 from: https://www.chp.gov.hk/en/static/51256.html
- Kaner EF, Beyer FR, Muirhead C, Campbell F, Pienaar ED, Bertholet N, Daeppen JB, Saunders JB, Burnand B. Effectiveness of brief alcohol interventions in primary care populations. Cochrane Database Syst Rev. 2018 Feb 24;2(2):CD004148. doi: 10.1002/14651858.CD004148.pub4.
- Fachini A, Aliane PP, Martinez EZ, Furtado EF. Efficacy of brief alcohol screening intervention for college students (BASICS): a meta-analysis of randomized controlled trials. Subst Abuse Treat Prev Policy. 2012 Sep 12;7:40. doi: 10.1186/1747-597X-7-40.
- Kaner EF, Beyer FR, Garnett C, Crane D, Brown J, Muirhead C, Redmore J, O'Donnell A, Newham JJ, de Vocht F, Hickman M, Brown H, Maniatopoulos G, Michie S. Personalised digital interventions for reducing hazardous and harmful alcohol consumption in community-dwelling populations. Cochrane Database Syst Rev. 2017 Sep 25;9(9):CD011479. doi: 10.1002/14651858.CD011479.pub2.
- Larimer ME, Cronce JM, Lee CM, Kilmer JR. Brief intervention in college settings. Alcohol Res Health. 2004-2005;28(2):94-104.
- Moyer A, Finney JW, Swearingen CE, Vergun P. Brief interventions for alcohol problems: a meta-analytic review of controlled investigations in treatment-seeking and non-treatment-seeking populations. Addiction. 2002 Mar;97(3):279-92. doi: 10.1046/j.1360-0443.2002.00018.x.
- Fowler LA, Holt SL, Joshi D. Mobile technology-based interventions for adult users of alcohol: A systematic review of the literature. Addict Behav. 2016 Nov;62:25-34. doi: 10.1016/j.addbeh.2016.06.008. Epub 2016 Jun 7.
- 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.
- Hoermann S, McCabe KL, Milne DN, Calvo RA. Application of Synchronous Text-Based Dialogue Systems in Mental Health Interventions: Systematic Review. J Med Internet Res. 2017 Jul 21;19(8):e267. doi: 10.2196/jmir.7023.
- 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.
- Bock BC, Barnett NP, Thind H, Rosen R, Walaska K, Traficante R, Foster R, Deutsch C, Fava JL, Scott-Sheldon LA. A text message intervention for alcohol risk reduction among community college students: TMAP. Addict Behav. 2016 Dec;63:107-13. doi: 10.1016/j.addbeh.2016.07.012. Epub 2016 Jul 18.
- Michie S, Whittington C, Hamoudi Z, Zarnani F, Tober G, West R. Identification of behaviour change techniques to reduce excessive alcohol consumption. Addiction. 2012 Aug;107(8):1431-40. doi: 10.1111/j.1360-0443.2012.03845.x. Epub 2012 Apr 17.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Chat-based ABI (UniStudents)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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