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临床试验/NCT05625685
NCT05625685撤回不适用

Accelerating Health Equity Via Just-In-Time Adaptive Interventions (JITAIs): Scalable and High Impact mHealth Precision Smoking Relapse Prevention.

Bryan W. Heckman2 个研究点 分布在 1 个国家开始时间: 2023年10月2日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
Abstinence Rate

研究概览

简要总结

The goal of this clinical trial is to test a GPS (Global Positioning System)-enabled smartphone app (QuitBuddy) in current smokers. The main questions it aims to answer are:

  • Is Quitbuddy a good treatment for quitting smoking and "staying quit"?
  • Will a second treatment that connects people to help for their social and financial needs improve Quitbuddy?

Participants will:

  • get nicotine lozenges in the mail
  • check in with the study team to report on their quitting progress after 1 day, 1 week, 1 month, 2 months, 3 months, and 6 months

Researchers will compare Quitbuddy to an app made by the National Cancer Institute to see if Quitbuddy is better for helping people stay quit.

详细描述

Tobacco smoking is a primary preventable trans-diagnostic risk factor that if targeted more effectively, could reduce a wide range of health disparities in prevalence, severity, treatment efficacy, and mortality across many chronic health conditions (e.g., diabetes, obstructive sleep apnea), reduce treatment complexity/multi-morbidity, and reduce healthcare costs up to 80%. The Southeast, in particular, has an urgent need to disrupt the status quo of tobacco control (<2% The Centers for Disease Control and Prevention (CDC) recommended tobacco control appropriations; highest smoking and mortality) driven in large part through neglected patterns of social determinants of health (SDoH; poverty, access to care) that disproportionately impact racial and ethnic minorities in the form of greater smoking and chronic disease rates, and ultimately nearly a decade of life lost. Unfortunately, only 5% of smoking cessation attempts last at least one year, with lower success among Black smokers even though they smoke at similar rates and intensity, and make more quit attempts. Accordingly, mobile health (mHealth) may have particular utility in addressing racial disparities.

Black smokers show high engagement rates with smartphones to access healthcare and greater adherence to digital interventions, which may facilitate tailoring to meet distinct needs. There is an urgent need to overcome equity gaps, which will require diversity and inclusion of individuals from underrepresented races/ethnicities to identify effective treatments. There is a need for just-in-time adaptive interventions (JITAIs) that 1) can be deployed rapidly (ideally before craving occurs), 2) effectively prevent or attenuate cravings quickly, and 3) are amenable to personalized treatment. Quitbuddy, the automated, yet personalized, JITAI app developed by the investigators, allows patients to prepare for high-risk situations before they arise, effectively promoting abstinence and preventing relapse. The overall goals are to optimize smart algorithms, identify personalized relapse risk, and automatically prompt NRT delivery in a real-time, preemptive manner, upon approaching personalized high-risk locations. Results from a National Institute on Drug abuse (NIDA)-funded (K23) pilot randomized controlled trial demonstrated outstanding usability (top 10% of over 500 apps), acceptability (>80% compliance), and technical feasibility (<10% GPS data loss). The investigators will build upon these promising data by testing effectiveness in a fully powered and rigorous SMART design with diverse representation of underserved populations and meeting community needs for SDoH interventions.

Specific Aims

Aims 1 & 2: Evaluate QuitBuddy and SDoH augmentation intervention effectiveness for smoking cessation and relapse prevention via pragmatic remote SMART design (N=2,090).

Expected Outcome: Superior 6-month biochemically verified abstinence rates for the QuitBuddy and SDoH augmentation interventions, relative to controls.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • At least 21 years of age
  • Smoking at least 10 cigarettes per day for the past year
  • Literate in English/Spanish
  • Willing to make a NRT-aided quit attempt within the next week

排除标准

  • Pregnancy (according to urine pregnancy test)
  • Breastfeeding or planning to become pregnant (self-report)
  • Recent (past 3 months) cardiovascular trauma: myocardial infarction, stroke (self-report)
  • Current use (past 30 days) of alternative tobacco products (e.g., electronic cigarettes, smokeless tobacco) or smoking cessation medications (self-report)

结局指标

主要结局

Abstinence Rate

时间窗: 24 hours

Self-report. Participant enters number of cigarettes smoked.

Withdrawal 6-month

时间窗: Measured six months after a participant's target quit-date.

Minnesota Nicotine Withdrawal Scale - A nine-item self-report scale for examining the severity of nicotine withdrawal symptoms in a subject. Participants select 0 (none) - 4 (severe) for each of the items. Higher scores correspond to higher perceived severity of withdrawal.

Cravings

时间窗: 24 hours

Self reported number of cravings experienced.

Withdrawal 1-day

时间窗: Measured one day after a participant's target quit-date.

Minnesota Nicotine Withdrawal Scale - A nine-item self-report scale for examining the severity of nicotine withdrawal symptoms in a subject. Participants select 0 (none) - 4 (severe) for each of the items. Higher scores correspond to higher perceived severity of withdrawal.

Withdrawal 1-week

时间窗: Measured one week after a participant's target quit-date.

Minnesota Nicotine Withdrawal Scale - A nine-item self-report scale for examining the severity of nicotine withdrawal symptoms in a subject. Participants select 0 (none) - 4 (severe) for each of the items. Higher scores correspond to higher perceived severity of withdrawal.

Withdrawal 1-month

时间窗: Measured one month after a participant's target quit-date.

Minnesota Nicotine Withdrawal Scale - A nine-item self-report scale for examining the severity of nicotine withdrawal symptoms in a subject. Participants select 0 (none) - 4 (severe) for each of the items. Higher scores correspond to higher perceived severity of withdrawal.

Withdrawal 2-month

时间窗: Measured two months after a participant's target quit-date.

Minnesota Nicotine Withdrawal Scale - A nine-item self-report scale for examining the severity of nicotine withdrawal symptoms in a subject. Participants select 0 (none) - 4 (severe) for each of the items. Higher scores correspond to higher perceived severity of withdrawal.

Withdrawal 3-month

时间窗: Measured three months after a participant's target quit-date.

Minnesota Nicotine Withdrawal Scale - A nine-item self-report scale for examining the severity of nicotine withdrawal symptoms in a subject. Participants select 0 (none) - 4 (severe) for each of the items. Higher scores correspond to higher perceived severity of withdrawal.

NRT Compliance

时间窗: 24 hours

Self report. Participant enters number of nicotine lozenges used.

次要结局

未报告次要终点

研究者

发起方
Bryan W. Heckman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Bryan W. Heckman

Associate Professor

Meharry Medical College

研究点 (2)

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