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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

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.

Condition or disease Intervention/treatment Phase
Alcohol Misuse 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 IM Apps Behavioral: AUDIT score interpretation sheet adapted from the Department of Health of Hong Kong Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 770 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : September 30, 2020
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

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
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: 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

Active Comparator: control group
Alcohol brief intervention, leaflets, regular messages on general health through IM Apps
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: 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




Primary Outcome Measures :
  1. 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.

  2. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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


  20. 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


  21. 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


  22. 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


  23. 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.

  24. 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

  25. 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


  26. 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


  27. 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

  28. 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

  29. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04025151


Contacts
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Contact: Siu Long Chau, PhD +852-39176981 h1357885@connect.hku.hk

Locations
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Hong Kong
School of Nursing, The University of Hong Kong
Hong Kong, Hong Kong, 000000
Contact: Siu Long Chau, PhD    +852-39176981    h1357885@connect.hku.hk   
Sponsors and Collaborators
The University of Hong Kong
Publications:
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

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Responsible Party: Dr. Wang Man-Ping, Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT04025151    
Other Study ID Numbers: Chat-based ABI (UniStudents)
First Posted: July 18, 2019    Key Record Dates
Last Update Posted: September 18, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Wang Man-Ping, The University of Hong Kong:
chat-based IM
alcohol brief intervention
alcohol misuse
university students
Additional relevant MeSH terms:
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Alcohol Drinking
Drinking Behavior