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临床试验/NCT06234475
NCT06234475进行中(未招募)不适用

A Randomized 2 by 2 Factorial Trial on mHealth Support and Financial Incentives to Promote Smoking Cessation in Deprived Older Smokers

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2024年2月20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
1,200
试验地点
1
主要终点
The biochemically validated smoking abstinence

研究概览

简要总结

This study aims to assess the effect of mobile health (mHealth) support or financial incentives and their interactive intervention effect on smoking cessation (SC) in old smokers in Hong Kong (HK).

详细描述

Low-income older smokers are disproportionally harmed by tobacco use and the evidence of effectiveness of smoking cessation (SC) intervention for this deprived group is scarce. Leveraging evidence of effectiveness of mHealth support and financial incentives in other adults, the investigators propose a scalable mHealth and/or financial incentives model using age-friendly components for the deprived older smokers.

The 2x2 factorial design consists of 2 interventions, including (1) smartphone mHealth support by scheduled age-friendly multimedia e-messages and real-time personalized behavioral supports for 3 months, and (2) an escalating incentive scheme for smoking abstinence: HK$500 for using any SC services within 6 months, and HK$1000, 1500 and 2000 for biochemically validated abstinence at 3-, 6- and 12-month, respectively.

The study aims to assess the effectiveness of two interventions and their interactive intervention effect.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • •Smokers aged 60 years or above;
  • •Currently smoking cigarettes or alternative tobacco products daily in the past 3 months with an exhaled carbon monoxide (CO) level ≥4ppm or salivary cotinine >30 ng/ml;
  • •Have a mobile phone that can receive short message/messaging Service (SMS) or instant messages (IM);
  • •Having a household monthly income lower than the median income of domestic household in Hong Kong
  • •6. Hong Kong residents able to communicate in Chinese.

排除标准

  • •Smokers not physically nor mentally fit for communication;
  • •Smokers currently using SC services;
  • •Hospitalized smokers;
  • •Not having a mobile phone or perceived difficulty in using mobile phone or communication Apps

研究组 & 干预措施

Mobile health group

Experimental

Smartphone mHealth support for smoking cessation by scheduled age-friendly multimedia e-messages and real-time personalized behavioral supports for 3 months.

干预措施: Mobile health support (Behavioral)

Financial incentive group

Experimental

An escalating incentive scheme for smoking abstinence: HK$500 for using any SC services within 6 months, and HK$1000, 1500 and 2000 for biochemically validated abstinence at 3-, 6- and 12-month, respectively.

干预措施: Financial incentive (Behavioral)

Combined intervention group

Experimental

Smartphone mHealth support for smoking cessation by scheduled age-friendly multimedia e-messages and real-time personalized behavioral supports for 3 months and an escalating incentive scheme for smoking abstinence: HK$500 for using any SC services within 6 months, and HK$1000, 1500 and 2000 for biochemically validated abstinence at 3-, 6- and 12-month, respectively.

干预措施: Combine intervention (Behavioral)

Control group

Active Comparator

Brief advice

干预措施: Control group (Behavioral)

结局指标

主要结局

The biochemically validated smoking abstinence

时间窗: the 6-month follow-ups

Smoking abstinence is defined by exhaled CO \< 4 ppm and salivary cotinine \<30 ng/ml

次要结局

  • Self-reported 7-day point-prevalence abstinence(3-, 6-, and 12-month follow-ups)
  • Self-reported self-efficacy of quitting(3-, 6-, and 12-month follow-ups)
  • Self-reported smoking change(3-, 6-, and 12-month follow-ups)
  • Self-reported quit attempts(3-, 6-, and 12-month follow-ups)
  • The biochemically validated smoking abstinence(the 3- and 12-month follow-ups)
  • Smoking cessation services use(3-, 6-, and 12-month follow-ups)
  • Nicotine dependence level(3-, 6-, and 12-month follow-ups)
  • Self-reported intention to quit(3-, 6-, and 12-month follow-ups)

研究者

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

Prof. Wang Man-Ping

Professor

The University of Hong Kong

研究点 (1)

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