Navigation and Artificial Intelligence Technology for Indigenous Virtual Education on Smoking Cessation (NAITIVE)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 772
- 试验地点
- 1
- 主要终点
- 30-day point prevalence abstinence (PPA)
研究概览
简要总结
This clinical trial develops a chatbot smartphone application (app), QuitBot, and text messaging to help American Indians (AI) and Alaska Natives (AN) to quit smoking commercial tobacco (smoking cessation), and evaluates two remote smoking cessation programs to see how well they work for helping AI/AN people quit smoking commercial tobacco. AI/AN populations have one of the highest rates of commercial cigarette smoking of any racial and ethnic group in the United States (US). They also have a higher rate of developing smoking-related cancer but are less likely to quit smoking. The two programs are designed to provide personalized support in setting a smoking cessation goal, tasks to reach the smoking cessation goal, and motivation to remain smoke-free. This may help to keep participants engaged and support them in their quit efforts, and may improve smoking cessation among AI and AN.
详细描述
OUTLINE: Participants are randomized to 1 of 2 arms. Both groups receive access to a 42-day quit smoking program.
ARM I: Participants receive daily QuitBot program chatbot messages about the importance of quitting smoking, setting a quit date, preparing to quit, quitting, and maintaining abstinence over 42 days.
ARM II: Participants receive daily QuitBot text messages about the importance of quitting smoking, setting a quit date, preparing to quit, quitting, and maintaining abstinence over 42 days.
After completion of study intervention, participants are followed up at 3, 6, and 12 months and may be contacted thereafter for up to 24 months.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Random assignments will be concealed from participants and researchers throughout the trial. Follow-up data will be collected by survey research unit that will be blind to random assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Self-identifying as American Indian or Alaska Native, either alone or in combination with other races
- •Age 18 and older
- •Smoking combustible cigarettes daily in the past year
- •Interest in quitting smoking
- •Interest in learning skills to quit smoking
- •Willing to be randomly assigned
- •Have daily access to their own Android or iPhone smartphone
- •Ability to download a smartphone app
- •Ability to read English
- •Not currently (i.e., within past 30 days) using other smoking cessation interventions
- •No prior participation in our studies
- •No prior use of SFT
- •No household or family member participating
- •US residency for the next twelve months
- •Willingness to complete follow-up assessments at the 3-, 6-, and 12-month follow-ups
- •Providing email, phone number(s), and mailing address
排除标准
- •The reverse of the inclusion criteria
- •Pregnant or breastfeeding
- •Use of other tobacco products (e.g., ceremonial use of tobacco, e-cigarettes) will be assessed but is not an exclusion criterion, as it would limit the study's generalizability
研究组 & 干预措施
Arm II (QuitBot texting)
Participants participate in the QuitBot program which involves text messages over 42 days. Therapy description withheld to protect the integrity of the study.
干预措施: Survey Administration (Other)
Arm II (QuitBot texting)
Participants participate in the QuitBot program which involves text messages over 42 days. Therapy description withheld to protect the integrity of the study.
干预措施: Carbon Monoxide Measurement (Procedure)
Arm I (QuitBot chatbot)
Participants participate in the QuitBot program which involves chatbot messages over 42 days. Therapy description withheld to protect the integrity of the study.
干预措施: QuitBot Smoking Cessation Chatbot Program (Device)
Arm I (QuitBot chatbot)
Participants participate in the QuitBot program which involves chatbot messages over 42 days. Therapy description withheld to protect the integrity of the study.
干预措施: Survey Administration (Other)
Arm I (QuitBot chatbot)
Participants participate in the QuitBot program which involves chatbot messages over 42 days. Therapy description withheld to protect the integrity of the study.
干预措施: Interview (Other)
Arm I (QuitBot chatbot)
Participants participate in the QuitBot program which involves chatbot messages over 42 days. Therapy description withheld to protect the integrity of the study.
干预措施: Carbon Monoxide Measurement (Procedure)
Arm II (QuitBot texting)
Participants participate in the QuitBot program which involves text messages over 42 days. Therapy description withheld to protect the integrity of the study.
干预措施: QuitBot Smoking Cessation Text Messaging Program (Device)
结局指标
主要结局
30-day point prevalence abstinence (PPA)
时间窗: At 12-months post-randomization
Will use a logistic regression model and standard smoking cessation trial intent-to-treat analysis, with all missing outcomes will be coded as smoking. The model will adjust for stratification factors and baseline factors that are significantly related to the outcome. Sensitivity analyses will include: (1) multiple imputation of missing outcomes, (2) complete case analysis, and (3) carbon monoxide (CO)-verified results adjusted for use of other combustible nicotine-containing tobacco products at the 12-month follow-up-in order to differentiate them from use of cigarettes at 12 months.
次要结局
- 30-day PPA(At 3- and 6- months post-randomization)
- Measures of bond between user and conversational chatbot(At 3- and 6-months post-randomization)
- Agreement on goals of treatment(At 3- and 6-months post-randomization)
- Agreement on tasks of treatment(At 3- and 6-months post-randomization)
- User's sense that QuitBot understands their needs(At 3- and 6-months post-randomization)