Digital Smoking Cessation Intervention for Nationally-Recruited American Indians and Alaska Natives: A Full-Scale Randomized Controlled Trial (IndigeQuit)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 776
- 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 compares a new smoking cessation smartphone application (app) (IndigeQuit) to an existing smarphone app (National Cancer Institute [NCI] QuitGuide) for helping American Indians and Alaska Natives (AI/ANs) quit smoking. Compared to other racial/ethnic groups, AIANs have 6 times higher rates of developing smoking-related cancers, including lung cancer. Commercial cigarette smoking accounts for half of all deaths among AIANs nationwide. AIANs' often lack of access to smoking cessation interventions, which may be due to inequities in the healthcare system, lack of health insurance, living in rural areas, systemic racism, and historical trauma. There is also a lack of effective smoking cessation interventions for AIANs. Smartphone apps have the potential to deliver a low-cost smoking cessation intervention with wide reach to AIANs. Apps require no in-person delivery and no provider training, do not require integration into complex hospital systems, can be freely accessed on an app store, and are available at any time and any place. IndigeQuit is a behavioral intervention designed to help adults stop smoking by teaching skills for coping with smoking urges, staying motivated, and preventing relapse. The IndigeQuit app intervention may be more effective than the currently available NCI QuitGuide app at helping AIANs quit smoking.
详细描述
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants use the IndigeQuit app, which includes setting up a personalized quit plan, participating in eight levels of the content, receiving on-demand help in coping with smoking urges, and tracking their daily smoking behaviors for at least 45 days on study.
ARM II: Participants use the NCI QuitGuide app for at least 45 days on study.
After completion of study intervention, patients are followed up at 3, 6, and 12-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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Random assignments will be concealed from participants and research staff throughout the trial.
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-identify as American Indian or Alaska Native, either alone or in combination with other races
- •Age 18 and older
- •Has smoked daily for the past year
- •Interest in quitting smoking within the next 30 days
- •Willing to be randomly assigned to either app
- •Have daily access to their own Android or iPhone
- •Able to download a smartphone app
- •Be willing and able to read English
- •Not currently or within past 30 days using other smoking cessation behavioral interventions or smoking cessation pharmacotherapies
- •Have never participated in our prior research
- •Have no other household or family member participating
- •Being willing to complete the 3, 6, and 12-month follow-up assessments
- •Providing email, phone number(s), and mailing address
- •Living off United States (US) AI/AN tribal reservations or living on five Northern Plains tribal reservations from whom we would obtain approvals to recruit
排除标准
- •Currently (i.e., within past 30 days) using other smoking cessation behavioral interventions
- •Has participated in our prior research trials
- •Has used the National Cancer Institute's (NCI's) QuitGuide app
- •Not willing to complete a follow-up survey at 3, 6, and 12 months post-randomization
- •Not providing email, phone number(s), and mailing address
研究组 & 干预措施
Arm II (NCI QuitGuide app)
Participants use the NCI QuitGuide app for at least 45 days on study.
干预措施: Biospecimen Collection (Procedure)
Arm II (NCI QuitGuide app)
Participants use the NCI QuitGuide app for at least 45 days on study.
干预措施: Smoking Cessation Intervention (Behavioral)
Arm II (NCI QuitGuide app)
Participants use the NCI QuitGuide app for at least 45 days on study.
干预措施: Survey Administration (Other)
Arm I (IndigeQuit app)
Participants use the IndigeQuit app, which includes setting up a personalized quit plan, participating in eight levels of the content, receiving on-demand help in coping with smoking urges, and tracking their daily smoking behaviors for at least 45 days on study.
干预措施: Biospecimen Collection (Procedure)
Arm I (IndigeQuit app)
Participants use the IndigeQuit app, which includes setting up a personalized quit plan, participating in eight levels of the content, receiving on-demand help in coping with smoking urges, and tracking their daily smoking behaviors for at least 45 days on study.
干预措施: Smoking Cessation Intervention (Behavioral)
Arm I (IndigeQuit app)
Participants use the IndigeQuit app, which includes setting up a personalized quit plan, participating in eight levels of the content, receiving on-demand help in coping with smoking urges, and tracking their daily smoking behaviors for at least 45 days on study.
干预措施: Survey Administration (Other)
结局指标
主要结局
30-day point prevalence abstinence (PPA)
时间窗: At 12 months post randomization
Will be assessed based on self-report with biochemical verification of salivary cotinine. For each comparison of treatment arms on cessation outcomes, will use a logistic regression model.
次要结局
- Self-reported 24-hour PPA(At the 3, 6, and 12-month follow-ups)
- 30-day PPA(At 3- and 6-months post randomization)
- Self-reported 7-day PPA(At the 3, 6, and 12-month follow-ups)