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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04025151
Recruitment Status : Not yet recruiting
First Posted : July 18, 2019
Last Update Posted : September 18, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Wang Man-Ping, The University of Hong Kong

Tracking Information
First Submitted Date  ICMJE July 16, 2019
First Posted Date  ICMJE July 18, 2019
Last Update Posted Date September 18, 2020
Estimated Study Start Date  ICMJE September 30, 2020
Estimated Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2019)
  • 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.
  • 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)
Original Primary Outcome Measures  ICMJE
 (submitted: July 16, 2019)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2020)
  • 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.
  • 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.
  • 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.
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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.
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2019)
  • 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.
  • Change in 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.
  • Change in number of standard drinks at 6-month and 12-month follow-up [ Time Frame: 6 and 12-month after baseline ]
    Assessed by either increase or decrease in standard drinks number and compared between intervention and control group at 6-month and 12-month follow-up
  • change in episode of binge drinking measured by asking "Never", "less than a month", "two to four times a month", " two to three times a week" and "almost everyday" [ Time Frame: at 6 and 12- months after baseline ]
    Defined by 5 [male] or 4 [female] in a row for binge drinking and compare the episode of binge drinking between intervention group and control at baseline, 6 and 12-month follow-up questionnaires
  • change in episode of heavy drinking measured by asking "Never", "less than a month", "two to four times a month", " two to three times a week" and "almost everyday" [ Time Frame: at 6 and 12- months after baseline ]
    Defined by 15 [male] or 8 [female] in a row for binge drinking and compare the episode of binge drinking between intervention group and control at baseline, 6 and 12-month follow-up questionnaires
  • Planned drinking measured by asking whether they planned to drink in the coming 30-day (yes or no) [ Time Frame: at 6 and 12- months after baseline ]
    Compare the number of planned drinking between intervention group and control group at baseline, 6 and 12-month follow-up questionnaires
  • Change in Academic Role Expectation and Alcohol Scale at 6 and 12-month follow-up [ Time Frame: at 6 and 12- months 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, 6 and 12-month follow-up questionnaires
  • Change in Alcohol Problems Scale at 6 and 12-month follow-up [ Time Frame: at 6 and 12- months 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, 6 and 12-month follow-up questionnaires
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nurse-led Alcohol Brief Intervention Plus Mobile Personalized Chat-based Support on Reducing Alcohol Use in University Students
Official Title  ICMJE Nurse-led Alcohol Brief Intervention Plus Mobile Personalized Chat-based Support on Reducing Alcohol Use in University Students: a Pragmatic Randomized Controlled Trial
Brief 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.
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:

  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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alcohol Misuse
Intervention  ICMJE
  • 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
  • Behavioral: 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.
  • Behavioral: 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.
  • Behavioral: 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.
  • Behavioral: 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.
  • Behavioral: 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
Study Arms  ICMJE
  • Experimental: Intervention group
    Alcohol brief intervention, leaflets, regular personalized messages on ABI through IM Apps, real-time chat-based support through IM Apps
    Interventions:
    • 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
  • Active Comparator: control group
    Alcohol brief intervention, leaflets, regular messages on general health through IM Apps
    Interventions:
    • Behavioral: Alcohol brief intervention
    • Behavioral: 12-page health warning leaflet
    • Behavioral: General health through IM Apps
    • Behavioral: AUDIT score interpretation sheet adapted from the Department of Health of Hong Kong
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 16, 2019)
770
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2022
Estimated Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Siu Long Chau, PhD +852-39176981 h1357885@connect.hku.hk
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04025151
Other Study ID Numbers  ICMJE Chat-based ABI (UniStudents)
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Wang Man-Ping, The University of Hong Kong
Study Sponsor  ICMJE The University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The University of Hong Kong
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP