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临床试验/NCT05627765
NCT05627765已完成不适用

An Integrated Smoking Cessation and Alcohol Intervention Among Hong Kong Chinese Young People: A Feasibility Randomized Controlled Trial

The Hong Kong Polytechnic University2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年7月1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
2
主要终点
screening rate

研究概览

简要总结

The specific objectives of this study are to investigate the (1) feasibility, (2) preliminary effectiveness and (3) effect sizes of the integrated smoking cessation and alcohol intervention when compared to standalone smoking cessation (ST) and control among young adults in Hong Kong.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • aged 18 to 25 years
  • smoked at least one traditional cigarette in the past 30 days
  • consumed at least one alcohol unit (one "alcohol unit" contains 10g of pure alcohol) in the past 30 days
  • speak Cantonese.

排除标准

  • have a compromised mental status and/or communication problems
  • participating in other smoking cessation and/or alcohol interventions

结局指标

主要结局

screening rate

时间窗: From screening to the end of treatment after 6 months

the number of smokers screened divided by the number of smokers available for screening

eligibility rate

时间窗: From screening to the end of treatment after 6 months

the number of eligible smokers divided by the number of screened people

consent rate

时间窗: From screening to the end of treatment after 6 months

the number of eligible smokers who agree to participate divided by the number of eligible smokers

randomization rate

时间窗: From screening to the end of treatment after 6 months

the number of participants who are randomized divided by the number of eligible smokers who consent to participate

attendance rate

时间窗: From screening to the end of treatment after 6 months

the number of participants who complete the intervention divided by the number of participants who are randomized into the treatment arms (ST and II)

adherence to intervention

时间窗: From screening to the end of treatment after 6 months

the number of participants in the two treatment arms who practice the skills learned during the intervention divided by the number of participants in the two treatment arms

retention rate

时间窗: From screening to the end of treatment after 6 months

the number of participants who remain in the study divided by the number of participants randomized

completion rate

时间窗: From screening to the end of treatment after 6 months

the number of participants who complete the questionnaire divided by the number of questionnaires distributed

missing data

时间窗: From screening to the end of treatment after 6 months

the percentage of missing data

adverse events

时间窗: From screening to the end of treatment after 6 months

unfavorable or unintended events during the study period that were not present at baseline or appear to have worsened since baseline

次要结局

  • Smoking quit rate(From screening to the end of treatment after 6 months)
  • alcohol quit rate(From screening to the end of treatment after 6 months)

研究者

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

Dr Eva Ho

associate professor

The Hong Kong Polytechnic University

研究点 (2)

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