Alcohol Brief Intervention Integrated With Mobile Chat-based Support for Risky Drinkers in Emergency Departments: a Pragmatic Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 632
- 试验地点
- 2
- 主要终点
- Amount of alcohol consumption per week (gram/week) at 12-month follow-up
研究概览
简要总结
This study aims to assess the effectiveness of chat-based intervention on reducing risky alcohol consumption to inform clinical practice for providing ABI to risky drinkers attending AED in Hong Kong.
详细描述
Alcohol use is a major risk factor for non-communicable diseases and 6th leading cause of death and disability-adjusted life years. The prevalence of alcohol consumption has increased since 2008 after introduction of zero tax on alcohol with strength <30% (e.g., wine and beer) and due to promoting the city as Asia's wine hub. ABI reduced alcohol intake by about 20g/week at 12-month follow-up in primary healthcare populations. Given the relatively low prevalence of risky alcohol drinkers in Hong Kong, testing ABI in clinics may face difficulties in recruitment. Alcohol use is associated with problems such as injury and violence requiring accident and emergency department (AED) services, thus AEDs in Hong Kong are more feasible places to recruit subjects for delivering ABI.
Primary hypothesis: The Intervention group has significantly larger reduction of weekly alcohol consumption compared with the Control group at 12-month follow-up
Secondary hypotheses: Compared with the Control group, the Intervention group has lower AUDIT scores, fewer episodes of heavy/binge drinking, lower re-attendence at AED and reduced alcohol-related harms at 6-month and 12-month follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •HK resident able to read/communicate in Cantonese/Putonghua. This may exclude potential subjects from other countries with higher alcohol consumption than local Chinese, but quality of the chat-based intervention is important for the research hypothesis, and it will not be feasible to recruit other language speakers (e.g., English) in the present study.
- •Aged ≥18 with proficiency in using IM Apps (e.g., WhatsApp, WeChat). Those aged <18 are excluded as other studies suggest they have different patterns of alcohol drinking and reduction from adult drinkers.
排除标准
- •Those unable to understand or receive face-to-face ABI due to severe traumatic injury, unconscious, or drunk patients unable to follow commands
- •Anticipated to be admitted to in-patient department for >1 week, which will interfere with the chat-based intervention
- •Having psychiatric/psychological diseases or receiving regular psychotropic medication
- •Participating in other alcohol reduction or abstinence programmes
结局指标
主要结局
Amount of alcohol consumption per week (gram/week) at 12-month follow-up
时间窗: 12-month after baseline
Assessed by unit in gram and compare the alcohol consumption between intervention and control group at 12-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
时间窗: 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)
次要结局
- Amount of alcohol consumption per week (gram/week) at 3- and 6-month follow-ups(3 and 6 months after baseline)
- Episode of binge drinking in the past 30-day at 3-, 6- and 12-month follow-ups(3, 6, and 12 months after baseline)
- Planned drinking measured in the coming 30-day at 3-, 6- and 12-month follow-ups(3, 6, and 12 months after baseline)
- AUDIT scores at 3-, 6- and 12-month follow-ups(3, 6 and 12 months after baseline)
- Number of standard drinks (10g of alcohol) per week at 3-, 6-, and 12-month follow-ups(3, 6 and 12 months after baseline)
- Episode of heavy drinking in the past 30-day at 3-, 6- and 12-month follow-ups(3, 6, and 12 months after baseline)
- Re-attendance of AED at 3-, 6- and 12-month follow-ups(3, 6, and 12 months after baseline)
- Health status of participants at 12-month(12 months after baseline)
- Current health of participants at 12-month(12 months after baseline)
- Health status of participants at 12-month(12 months after baseline)
- Current health of participants at 12-month(12 months after baseline)
- Amount of alcohol consumption per week (gram/week) at 3- and 6-month follow-ups(3 and 6 months after baseline)
- AUDIT scores at 3-, 6- and 12-month follow-ups(3, 6 and 12 months after baseline)
- Number of standard drinks (10g of alcohol) per week at 3-, 6-, and 12-month follow-ups(3, 6 and 12 months after baseline)
- Episode of binge drinking in the past 30-day at 3-, 6- and 12-month follow-ups(3, 6, and 12 months after baseline)
- Episode of heavy drinking in the past 30-day at 3-, 6- and 12-month follow-ups(3, 6, and 12 months after baseline)
- Planned drinking measured in the coming 30-day at 3-, 6- and 12-month follow-ups(3, 6, and 12 months after baseline)
- Re-attendance of AED at 3-, 6- and 12-month follow-ups(3, 6, and 12 months after baseline)
研究者
Dr. Wang Man-Ping
Professor
The University of Hong Kong