Mobile Phone-based Smoking Cessation Program for Individuals With Cardiovascular Risk or Disease in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Continuous smoking abstinence
研究概览
简要总结
In this online, randomized controlled trial (RCT), the participants will be randomized and allocated in 1:1 ratio to mobile phone-based intervention group or to the wait-list control group. Participants will receive a 12-week intervention with follow-up at week 26. The primary outcome includes biologically verified continuous smoking abstinence at week 26 after the quit date. The main secondary outcomes include seven-day point prevalence smoking abstinence at weeks 1, 2, 3, 4, 8, 12, 16, 20 and 26, self-reported continuous smoking abstinence at weeks 4, 8, 12, 16, 20 and 26 after the quit date. About 2000 smokers with willingness to make a quit attempt within a month from October 2022 to April 2023 or until the recruitment process is complete will be recruited. The final 26-week follow-up will be completed in November 2023. The trial results will be available by the end of 2023 .
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In this RCT, approximately 2,000 smokers (a smoker is defined as an individual who smoked 100 cigarettes in their lifetime, and currently smoke ≥ 5 cigarettes per day) who are willing to make a quit attempt within one month with CVDs diagnosis or risk.
排除标准
- •patients unwilling to quit smoking
研究组 & 干预措施
the wait-list control group
the wait-list control group
mobile phone-based intervention group
Participants will receive a 12-week intervention with follow-up at week 26.
干预措施: mobile phone-based intervention (Other)
结局指标
主要结局
Continuous smoking abstinence
时间窗: at week 26 after the quit date
biologically verified continuous smoking abstinence at week 26 after the quit date
次要结局
- self-reported continuous smoking abstinence(week 4, 8, 12, 16, 20 and 26 after the quit date)
- 7-day point prevalence smoking abstinence(week 1, 2, 3, 4, 8, 12, 16, 20 and 26)