Clinical trial NCT04025151: Nurse-led Alcohol Brief Intervention Plus Mobile Personalized Chat-based Support on Reducing Alcohol Use in University Students
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alcohol Misuse
Keywords: chat-based IM
alcohol brief intervention
alcohol misuse
university students
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2019-07-18
Enrollment: 770
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Amount of alcohol consumption per week (gram/week) at 6-month follow-up
timeFrame: 6-month after baseline
measure: Compare the primary outcome using intention-to-treat (ITT), per-protocol (PP) and as-treated (AP) analysis with Compliance Average Causal Effect (CACE) analysis
timeFrame: 6-month after baseline
Secondary outcomes:
measure: Amount of alcohol consumption per week (gram/week) at 12-month follow-up
timeFrame: 12-month after baseline
measure: AUDIT scores at 6-month follow-up
timeFrame: 6-month after baseline
measure: AUDIT scores at 12-month follow-up
timeFrame: 12-month after baseline
measure: Number of standard drinks (10g of alcohol) per week at 6-month follow-up
timeFrame: 6-month after baseline
measure: Number of standard drinks (10g of alcohol) per week at 12-month follow-up
timeFrame: 12-month after baseline
measure: Episode of binge drinking in the past 30-day at 6-month follow up
timeFrame: at 6-month after baseline
measure: Episode of binge drinking in the past 30-day at 12-month follow up
timeFrame: at 12-month after baseline
measure: Episode of heavy drinking in the past 30-day at 6-month follow up
timeFrame: at 6 -month after baseline
measure: Episode of heavy drinking in the past 30-day at 12-month follow up
timeFrame: at 12-month after baseline
measure: Planned drinking measured in the coming 30-day at 6-month follow up
timeFrame: at 6-month after baseline
measure: Planned drinking measured in the coming 30-day at 12-month follow up
timeFrame: at 12-month after baseline
measure: Academic Role Expectation and Alcohol Scale at 6-month follow-up
timeFrame: at 6-month after baseline
measure: Academic Role Expectation and Alcohol Scale at 12-month follow-up
timeFrame: at 12-month after baseline
measure: Alcohol Problems Scale at 6-month follow-up
timeFrame: at 6-month after baseline
measure: Alcohol Problems Scale at 12-month follow-up
timeFrame: at 12- month after baseline
measure: Mediation analysis of variables at 6-month on weekly amount of alcohol consumption at 12-month
timeFrame: at 12- month after baseline
measure: Subgroup analysis of baseline intention to quit/reduce drinking
timeFrame: at 12- month after baseline
measure: Content analysis of IM Apps conversation using alcohol BCT taxonomy
timeFrame: at 12- month after baseline
measure: Patient Health Questionnaire 4-item (PHQ-4) at 6-month
timeFrame: at 6-month after baseline
measure: Patient Health Questionnaire 4-item (PHQ-4) at 12-month
timeFrame: at 12-month after baseline
measure: Perceived Stress Scale 4-item (PSS-4) at 6-month
timeFrame: at 6-month after baseline
measure: Perceived Stress Scale 4-item (PSS-4) at 12-month
timeFrame: at 12-month after baseline
measure: Perceived usefulness of IM app intervention at 12-month
timeFrame: at 12-month after baseline
measure: Intention to continue using IM app intervention at 12-month
timeFrame: at 12-month after baseline
measure: Self-efficacy to reduce/quit drinking at 6-month
timeFrame: at 6-month after baseline
measure: Self-efficacy to reduce/quit drinking at 12-month
timeFrame: at 12-month after baseline
measure: Covid-19 related drinking behavioral changes at baseline
timeFrame: at baseline
measure: Covid-19 related drinking behavioral changes at 6-month
timeFrame: at 6-month
measure: Covid-19 related drinking behavioral changes at 12-month
timeFrame: at 12-month
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: School of Nursing, The University of Hong Kong
Study officials:
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