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临床试验/NCT06602882
NCT06602882进行中(未招募)不适用

Effectiveness and Usability of a Chatbot-delivered Screening and Brief Intervention for Alcohol Reduction in Working-age Adults: A Proof-of-concept Randomised Controlled Trial

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
300
试验地点
1
主要终点
Alcohol consumption in grams per week

研究概览

简要总结

Alcohol abuse led to 5.3% of all deaths and 5.1% of all disability-adjusted life years globally in 2016, representing a heavier public health burden than diabetes, tuberculosis or HIV/AIDS (as documented in the World Health Organization (WHO) Global Status Report on Alcohol and Health). The increasing consumption of alcohol for a few decades has led to a higher risk of cirrhosis, cancers, hypertension, and cardiovascular and cerebrovascular diseases. Strengthening of the prevention and treatment of alcohol abuse has been incorporated in the Sustainable Development Goals (SDG3) by the United Nations.

Strong evidence from a meta-analysis demonstrated the efficacy of screening and brief intervention (SBI) in reducing weekly alcohol consumption. Although SBI is known to be effective in reducing alcohol consumption in at-risk drinkers, barriers to implementing SBI have been an issue. A systematic review identified that common barriers to the routine delivery of SBI by doctors and nurses included a lack of alcohol-related knowledge, time, confidence, ability, and incentive to intervene; worrying about offending patients; and SBI being an uncomfortable and frustrating task.

To scale up behavioural change interventions in primary care for expanding the scalability and reachability, artificial intelligence (AI) and AI-chatbots have been increasingly used in recent years. A systematic review showed that chatbots for mental health counselling were effective and safe. Other reviews also reported that chatbots might improve physical activity, diet, and weight management and oncology care. However, having searched PubMed and the Cochrane Library, there was no a randomised controlled trial on the use of an AI-chatbot for alcohol reduction.

详细描述

Aim:

To adapt a self-developed SBI chatbot and conduct a proof-of-concept evaluation on its preliminary effectiveness and usability in reducing alcohol consumption after 4 weeks for at-risk working-age adults by using a randomised, open label, two-arm, parallel-group controlled trial.

Objectives of this project are:

  1. To evaluate the SBI chatbot for its short-term effectiveness in reducing alcohol consumption in at-risk working-age adults over a 4-week period (primary outcome).
  2. To evaluate the SBI chatbot in reducing alcohol-related harm risk measured by AUDIT scores over 4 week in at-risk working-age adults.
  3. To assess the usability of the SBI chatbot by at-risk working-age adults.
  4. To explore which factors are associated with, moderate, or mediate the effects of the SBI chatbot.

Hypotheses Hypothesis 1 (Primary outcome): Participants receiving chatbot-delivered SBI (intervention group) will have a higher reduction in weekly alcohol consumption (grams/week) than those in the waitlist control group at 4-week 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
Screening
盲法
Single (Outcomes Assessor)

盲法说明

Blinding of the study participants will not be possible. However, as the questionnaires will be completed via an online platform instead of instant messaging app (i.e. WhatsApp), the outcome assessor will be blinded during data collection.

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •aged 18-59 years
  • •being employed in the past 12 months
  • •a modified Alcohol Use Disorders Identification Test (AUDIT-C) score ≥3
  • •having a smartphone with internet access
  • •able to communicate in Chinese

排除标准

  • •mentally and/or
  • •physically unable to complete the intervention and/or the two follow-ups
  • •undergoing any alcohol-related intervention

研究组 & 干预措施

Intervention group

Experimental

Participants in the intervention group will engage with a chatbot-delivered screening and brief intervention (SBI) over a 30-minute period on the chatbot webpage.

The SBI chatbot involves screening individuals for alcohol consumption by AUDIT before recruitment and then providing a brief intervention comprising personalised feedback. Its delivery is fully automated via a smartphone app.

干预措施: chatbot-delivered screening and brief intervention (Behavioral)

Waitlist control group

Experimental

All participants in the waitlist control will receive the SBI chatbot 4 weeks later. The intervention has the same content for both intervention and waitlist control groups.

干预措施: chatbot-delivered screening and brief intervention (Behavioral)

结局指标

主要结局

Alcohol consumption in grams per week

时间窗: 4-week follow-up

The primary outcome is the amount of alcohol consumed per week (grams/week) at the 4-week follow-up, which is recommended as the gold standard for determining effectiveness in many alcohol trials. The data collected for computing the alcohol consumption comprise type of alcohol (e.g. wine, beer, liquor, etc.) and units (e.g. 1 glass of 250ml, 1 can of 330 ml, etc.) consumed in the past week, which will be computed according to a formula with standard alcohol (unit per week) x 10 gram.

次要结局

  • AUDIT scores(4-week follow-up)
  • The 15-item Bot Usability Scale(4-week follow-up)
  • Economic evaluation(4-week follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Wang Man-Ping

Professor

The University of Hong Kong

研究点 (1)

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