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临床试验/NCT05297370
NCT05297370Unknown不适用

Mixed and Match Versus One-size-fits-all: A Randomized Controlled Trial of Self-determination Theory on a Menu of Smoking Cessation Options (SDTM) Among Adult Smokers

The Hong Kong Polytechnic University0 个研究点目标入组 500 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
入组人数
500
主要终点
Self-efficacy at 6-month follow-up

研究概览

简要总结

Most existing smoking cessation services are based on '5A's' and '5R's' models which are recognized by the World Health Organization as a standardized tool for smoking cessation. While there are more techniques that are known to be effective and could be incorporated in existing smoking cessation interventions to further promote their effectiveness. This study is to examine the effectiveness SDTM in assisting adult smokers in Hong Kong to quit.

详细描述

A randomized controlled trial (RCT) will be conducted. One-hundred adult smokers aged 25 or above will be recruited from smoking hotspots in Hong Kong. Participants in the intervention group will be contacted by our trained research assistant to receive a telephone counselling session at baseline. Participants can choose to receive their own smoking cessation treatment options from our menu. Control group participants will only receive a self-help quitting leaflet

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
None

入排标准

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

入选标准

  • have smoking in the previous 30 days.
  • be above 25 years old
  • able to speak Cantonese and read Chinese

排除标准

  • who are receiving current smoking cessation services
  • report psychological disorders
  • at risk of suicide

结局指标

主要结局

Self-efficacy at 6-month follow-up

时间窗: At 6-month follow-up

Participants will be asked about their self-efficacy in quitting. The score ranges from 0 to 10. Higher scores represent a higher self-efficacy.

Self-reported abstinence at 6-month follow-up

时间窗: At 6-month follow-up

participants will be asked about their self-reported abstinence in the past 7 and 30 days

Biochemically validated abstinence

时间窗: At 6 months follow-up

validate the self-reported abstinence if the level of carbon monoxide in expired air was less than 4 parts per million and saliva cotinine level was less than100 ng/mL in parallel tests

次要结局

  • Screening rate(at day 1)
  • Randomization rate(at day 1)
  • Retention rate at 3-month follow-up(At 3-month follow-up)
  • Adherence to intervention protocol at 6-month follow-up(At 6-month follow-up)
  • Attendance rate(Immediately after the training workshop)
  • Retention rate at 1-month follow-up(At 1-month follow-up)
  • Complete rate at 1-week follow-up(At 1-week follow-up)
  • Missing data at 3-month follow-up(At 3-month follow-up)
  • Self-efficacy at 1-week follow-up(at 1-week follow-up)
  • Retention rate at 1-week follow-up(At 1-week follow-up)
  • Complete rate at 1-month follow-up(At 1-month follow-up)
  • Eligibility rate(at day 1)
  • Retention rate at 6-month follow-up(At 6-month follow-up)
  • Adherence to intervention protocol at 1-week follow-up(At 1-week follow-up)
  • Adherence to intervention protocol at 1-month follow-up(At 1-month follow-up)
  • Adherence to intervention protocol at 3-month follow-up(At 3-month follow-up)
  • Missing data at 6-month follow-up(At 6-month follow-up)
  • Adverse events at 3-month follow-up(At 3-month follow-up)
  • Self-reported abstinence at 1-week follow-up(At 1-week follow-up)
  • Complete rate at 3-month follow-up(At 3-month follow-up)
  • Complete rate at 6-month follow-up(At 6-month follow-up)
  • Missing data at 1-month follow-up(At 1-month follow-up)
  • Adverse events at 1-month follow-up(At 1-month follow-up)
  • Self-reported abstinence at 1-month follow-up(At 1-month follow-up)
  • Self-reported abstinence at 3-month follow-up(At 3-month follow-up)
  • Missing data at 1-week follow-up(At 1-week follow-up)
  • Adverse events at 1-week follow-up(At 1-week follow-up)
  • Self-efficacy at 1-month follow-up(at 1-month follow-up)
  • Adverse events at 6-month follow-up(At 6-month follow-up)
  • Self-efficacy at 3-month follow-up(at 3-month follow-up)

研究者

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

Dr Katherine Lam

Research Assistant Professor

The Hong Kong Polytechnic University

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