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临床试验/NCT05680519
NCT05680519已完成不适用

Preventing Non-communicable Diseases by Screening and Educating Emergency Department Attendees on Health-risk Behaviours: A Pilot Randomized Controlled Trial

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年2月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
1
主要终点
Feasibility of the study

研究概览

简要总结

Aim:

To determine the feasibility and potential efficacy of a proactive approach using a brief self-determination theory-based intervention to help people attending the ED modify their health-risk behaviours and lead healthier lives.

Objectives

  1. To assess the recruitment, participation and retention rates of targeted participants in an emergency department
  2. To ascertain the feasibility of screening, recruiting and educating people to change health-risk behaviours in the emergency department

详细描述

Setting:

The setting is the ED of the United Christian Hospital (UCH), one of the major acute care hospitals in Kowloon East cluster in Hong Kong.

Intervention:

At the ED The potential participants will first be invited by our research assistant to complete a baseline behavioural risk factor survey. Those whose survey responses indicate that they are eligible participants will be explained the purpose and nature of the study and will be asked to sign an informed consent form. They will then be informed that they will receive a telephone call from a research assistant within 3 days to evaluate their assessment outcomes and provide them with appropriate interventions. The participants will also be given a Practical Resource Hub for Healthy Life leaflet containing information on various applications, including (i) 'Move Your Body', (ii) 'Eat Healthy', (iii) 'Live Alcohol Free', and (iv) 'Stay Away from Tobacco', which were developed by the Hong Kong Department of Health.

  1. Intervention group Brief intervention via telephone (within 3 days after visiting the ED) The participants will receive a brief intervention using the Ask, Warn, Advise, Refer and Do-it-again (AWARD) model, which was originally developed for primary-care tobacco-cessation interventions. The brief intervention includes the following steps: (1) ask about and assess health-risk behaviours; (2) warn about the high morbidity and mortality risks associated with health-risk behaviours; (3) advise to adopt healthy lifestyle practices to benefit the health of the participant; (4) refer to hotline services on request, such as smoking cessation and alcohol treatment services; and (5) do it again. For the warning message, the research assistant will provide the following standardised message: 'The WHO has identified four major behavioural risk factors, namely, tobacco use, harmful alcohol use, an unhealthy diet and physical inactivity, that contribute substantially to NCDs, which result in high rates of morbidity and mortality.' For the advice step, the research assistant will ask about the priority the participants place on engagement in desirable health-related lifestyle practices identified in the completed behavioural risk factor survey. The participants will also be asked to choose the goal that they consider easiest to achieve, such as quitting or reducing smoking, consuming more vegetables or less fatty foods or sugary drinks, performing more exercise or reducing alcohol consumption. The participants will be encouraged to quit health-risk behaviours (or adopt a healthy lifestyle) sequentially, but they will also be able to choose to quit them simultaneously if they are confident in doing so. Each participant will then receive a brief (approximately 5 minutes), individual intervention with health advice about the selected health-related lifestyle practice. The whole intervention will last approximately 10 minutes, but slightly longer if necessary. Such a brief intervention will be cost-effective and more feasible for routine use in clinical practice by healthcare professionals after minimal training. Previous clinical trials of smoking cessation have provided strong evidence regarding the effectiveness of brief interventions using the AWARD model.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (1) age ≥18 years,
  • (2) triage as semi-urgent (level 4) or non-urgent (level 5), and
  • (3) the presence of at least one health risk behaviour (tobacco use, harmful use of alcohol, unhealthy diet and physical inactivity)

排除标准

  • (1) poor cognitive state or mental illness and
  • (2) participation in another related study

结局指标

主要结局

Feasibility of the study

时间窗: 12 months

Assess the feasibility of the study through the participation/retention rate

Feasibility of the study

时间窗: at baseline

Assess the feasibility of the study through the recruitment/participation rate

Feasibility of the study

时间窗: 3 months

Assess the feasibility of the study through the participation/retention rate

Feasibility of the study

时间窗: 6 months

Assess the feasibility of the study through the participation/retention rate

次要结局

  • Change of physical inactivity(12 months)
  • Change of alcohol consumption(12 months)
  • Change of unhealthy diet(12 months)
  • Change of smoking consumption(12 months)
  • Change of smoking consumption(3 months)
  • Change of smoking consumption(6 months)
  • Change of alcohol consumption(3 months)
  • Change of alcohol consumption(6 months)
  • Change of physical inactivity(3 months)
  • Change of physical inactivity(6 months)
  • Change of unhealthy diet(3 months)
  • Change of unhealthy diet(6 months)

研究者

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

Li Ho Cheung William

Professor

Chinese University of Hong Kong

研究点 (1)

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