Effect of Helpers Program On-line Training on Smoking Relapse and Social Networks
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 940
- 试验地点
- 1
- 主要终点
- 7-day and 30-day abstinence from using combustible tobacco at 12 months post-randomization
研究概览
简要总结
The purpose of this study is to assess the effect of the Helpers Stay Quit training on abstinence over time of newly abstinent smokers, and on the interactions they have with their personal network related to smoking and smoking cessation.
详细描述
Despite major gains in smoking cessation treatment, over half of recently quit smokers will relapse within the first year. To date, relapse prevention interventions have focused on the newly abstinent smoker ("abstainer"), and not attempted to directly or indirectly influence the abstainer's personal network, e.g. by helping the abstainer influence others in their personal network to quit. Personal networks exert powerful effects on initiating and maintaining smoking behavior, and can facilitate maintaining abstinence or trigger relapse. A "help others" intervention that seeks to increase the abstainer's ability to influence smokers in their personal network to quit - thereby creating a social environment more supportive of long-term abstinence - may have a beneficial effect on relapse. The Helpers Stay Quit intervention encourages abstainers to reinforce their own abstinence through helping others quit, and to proactively influence their personal network to be more conducive to long-term smoking abstinence. Helpers Stay Quit teaches abstainers how to encourage other tobacco users to quit and avoid relapse through a non-confrontational "helping conversation" that encourages quitting and use of evidence-based cessation aids (e.g. Quitlines, cessation medications) without confrontation and nagging. The investigator hypothesizes that Quitline abstainers exposed to Helpers Stay Quit will have higher 30-day and 7-day point prevalence abstinence than those receiving Quitline follow-up usual care, and that the effect of Helpers Stay Quit may be mediated by personal network characteristics. To test this hypothesis, the investigator proposes a pragmatic randomized controlled trial with embedded mixed-methods personal network study to assess the effect of Helpers Stay Quit training on proportion and duration of abstainers' abstinence over time, and on abstainer's personal network interactions related to smoking and smoking cessation. Metrics derived from the personal network study will be used for mediational analyses of overall, and gender-based effects of Helpers Stay Quit on smoking relapse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Statistician analyzing outcomes is blinded to study arm assignment
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years or older
- •Abstinent from smoking for between 14 and 60 days
- •Primary tobacco use is cigarettes
- •Has access to Internet via computer or mobile device
- •Self-described proficiency with English
- •Willing and able to send/receive weekly text messages using personal mobile phone plan
- •Will allow Quitline to share their client data with research team
- •Willing to complete online surveys at baseline, 3-, 6-, 9- and 12 months
- •Willing to self-collect dried blood spot and send back to research team
- •If assigned to Helpers Stay Quit condition, willing to complete training within 14 days
- •If selected, willing to participate in qualitative interview
- •Willing to forego any other training for tobacco cessation intervention/support (i.e., to become a cessation counselor/facilitator or support person, e.g., 'quit buddy') for the duration of their study enrollment
排除标准
- •Any prior exposure to Helpers training or other cessation training in the previous 2 years
研究组 & 干预措施
Helpers Stay Quit Training
Research participants randomized to the experimental arm will receive the on-line Helpers Stay Quit training which provides training on how to help others quit smoking.
干预措施: Helpers Stay Quit Training (Behavioral)
Usual Care
Research participants randomized to the arm without intervention will receive Quitline usual care. They will be contacted for assessment of abstinence at 7 months after enrollment in services. If the participant has relapsed, the Quitline will attempt to re-engage the participant in cessation services (telephone and/or web-based).
结局指标
主要结局
7-day and 30-day abstinence from using combustible tobacco at 12 months post-randomization
时间窗: Self-reported data collected at 12 months post-randomization
Participants report the number of days (if any) they smoked combustible tobacco within the specified timeframe.
7-day and 30-day abstinence from using combustible tobacco at 6 months post-randomization
时间窗: Self-reported data collected at 6 months post-randomization
Participants report the number of days (if any) they smoked combustible tobacco within the specified timeframe.
次要结局
- Time to first relapse(Weekly data collected months 1-6, bi-weekly data collected months 7-12 post-randomization)
- Number of helping conversations offered(Weekly data collected months 1-6; bi-weekly data collected months 7-12; data collected at 3-, 6-, 9-, and 12-months post-randomization)
- Biochemical confirmation of abstinence at 6 and 12 months on a subsample(Data collected and 6- and 12-months post-randomization)
- 7-day and 30-day abstinence from using combustible tobacco at 3 months and 9 months post-randomization(Self-reported data collected at 3- and 9-months post-randomization)
- Number, timing, and duration of relapses(Weekly data collected months 1-6, bi-weekly data collected months 7-12 post-randomization)