Providing Nicotine Replacement Therapy to Enhance the Efficacy of a Smoking Cessation Smartphone App for Hispanic Adults
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 854
- 试验地点
- 1
- 主要终点
- 30-day point prevalence abstinence (PPA)
研究概览
简要总结
This phase III trial compares a smartphone application with or without nicotine replacement therapy in improving smoking cessation among Hispanic adults who would like to quit smoking. The iCanQuit smartphone application focuses on skills for managing urges, motivation, and relapse prevention with personalized quit plans. Nicotine replacement therapy works by giving small, steady doses of nicotine to help stop cravings and relieve symptoms that occur when a person is trying to quit smoking without any of the other harmful chemicals found in tobacco products.
详细描述
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive access to the iCanQuit smartphone application for 12 months and complete personalized quit plans with education regarding managing urges, motivation, and relapse prevention, on-demand help with tracking of daily cigarette consumption, and monitoring of urges passed without smoking.
ARM II: Participants receive access to the iCanQuit smartphone application for 12 months and complete personalized quit plans with education regarding managing urges, motivation, and relapse prevention, on-demand help with tracking of daily cigarette consumption, and monitoring of urges passed without smoking. Participants also receive NRT patch(es) and gum or lozenges to use per the usage instructions tailored to the participants' baseline smoking levels. In addition, participants receive daily push notifications with NRT dosage and refill reminders for 12 months.
After completion of study intervention, patients may be followed up at 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
To assure blinding, random assignments will be concealed from participants and researchers throughout the trial. Follow-up data will be collected by our survey research unit that will be blind to treatment arm
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 Hispanic ethnicity
- •Age 18 and older
- •Smoking at least one cigarette per day in the past 30 days
- •Want to quit smoking within 30 days
- •Interest in learning skills to quit smoking
- •Willing to be randomly assigned
- •United States (US) or Puerto Rico (PR) residency for the next twelve months
- •Have daily access to their own Android or iPhone smartphone
- •Ability to download a smartphone application (app)
- •Proficiency in English or Spanish
- •Not currently (i.e., within past 30 days) using other smoking cessation interventions
- •Willing to consider using NRT
- •No previous use of iCanQuit
- •No household or family member participating
- •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
- •NRT CONTRAINDICATION: Heart attack in the last 2 months
- •NRT CONTRAINDICATION: Stroke in the last 6 months
- •NRT CONTRAINDICATION: Diagnosed arrhythmia or tachycardia
- •NRT CONTRAINDICATION: Uncontrolled hypertension
- •NRT CONTRAINDICATION: Currently using warfarin
- •NRT CONTRAINDICATION: Pregnant or breastfeeding, or plans to become pregnant during the next 6 months
研究组 & 干预措施
Arm II (iCanQuit application and NRT)
Participants receive access to the iCanQuit smartphone application for 12 months and complete personalized quit plans with education regarding managing urges, motivation, and relapse prevention, on-demand help with tracking of daily cigarette consumption, and monitoring of urges passed without smoking. Participants also receive NRT patch(es) and gum to use per the usage instructions tailored to the participants' baseline smoking levels. In addition, participants receive daily push notifications with NRT dosage and refill reminders for 12 months.
干预措施: Interview (Other)
Arm I (iCanQuit application)
Participants receive access to the iCanQuit smartphone application for 12 months and complete personalized quit plans with education regarding managing urges, motivation, and relapse prevention, on-demand help with tracking of daily cigarette consumption, and monitoring of urges passed without smoking.
干预措施: iCanQuit Smartphone App Smoking Cessation Program (Device)
Arm II (iCanQuit application and NRT)
Participants receive access to the iCanQuit smartphone application for 12 months and complete personalized quit plans with education regarding managing urges, motivation, and relapse prevention, on-demand help with tracking of daily cigarette consumption, and monitoring of urges passed without smoking. Participants also receive NRT patch(es) and gum to use per the usage instructions tailored to the participants' baseline smoking levels. In addition, participants receive daily push notifications with NRT dosage and refill reminders for 12 months.
干预措施: Survey Administration (Other)
Arm I (iCanQuit application)
Participants receive access to the iCanQuit smartphone application for 12 months and complete personalized quit plans with education regarding managing urges, motivation, and relapse prevention, on-demand help with tracking of daily cigarette consumption, and monitoring of urges passed without smoking.
干预措施: Interview (Other)
Arm II (iCanQuit application and NRT)
Participants receive access to the iCanQuit smartphone application for 12 months and complete personalized quit plans with education regarding managing urges, motivation, and relapse prevention, on-demand help with tracking of daily cigarette consumption, and monitoring of urges passed without smoking. Participants also receive NRT patch(es) and gum to use per the usage instructions tailored to the participants' baseline smoking levels. In addition, participants receive daily push notifications with NRT dosage and refill reminders for 12 months.
干预措施: Nicotine Gum (Drug)
Arm II (iCanQuit application and NRT)
Participants receive access to the iCanQuit smartphone application for 12 months and complete personalized quit plans with education regarding managing urges, motivation, and relapse prevention, on-demand help with tracking of daily cigarette consumption, and monitoring of urges passed without smoking. Participants also receive NRT patch(es) and gum to use per the usage instructions tailored to the participants' baseline smoking levels. In addition, participants receive daily push notifications with NRT dosage and refill reminders for 12 months.
干预措施: Nicotine Patch (Drug)
Arm II (iCanQuit application and NRT)
Participants receive access to the iCanQuit smartphone application for 12 months and complete personalized quit plans with education regarding managing urges, motivation, and relapse prevention, on-demand help with tracking of daily cigarette consumption, and monitoring of urges passed without smoking. Participants also receive NRT patch(es) and gum to use per the usage instructions tailored to the participants' baseline smoking levels. In addition, participants receive daily push notifications with NRT dosage and refill reminders for 12 months.
干预措施: Nicotine Lozenge (Drug)
Arm I (iCanQuit application)
Participants receive access to the iCanQuit smartphone application for 12 months and complete personalized quit plans with education regarding managing urges, motivation, and relapse prevention, on-demand help with tracking of daily cigarette consumption, and monitoring of urges passed without smoking.
干预措施: Survey Administration (Other)
Arm II (iCanQuit application and NRT)
Participants receive access to the iCanQuit smartphone application for 12 months and complete personalized quit plans with education regarding managing urges, motivation, and relapse prevention, on-demand help with tracking of daily cigarette consumption, and monitoring of urges passed without smoking. Participants also receive NRT patch(es) and gum to use per the usage instructions tailored to the participants' baseline smoking levels. In addition, participants receive daily push notifications with NRT dosage and refill reminders for 12 months.
干预措施: iCanQuit Smartphone App Smoking Cessation Program (Device)
结局指标
主要结局
30-day point prevalence abstinence (PPA)
时间窗: At 12 months post randomization
The comparison will use a logistic regression model, following standard intent-to-treat analysis for smoking cessation trials, will be employed, coding all missing outcomes as smoking. The model will adjust for stratification factors and baseline factors that are both imbalanced after randomization and significantly related to the outcome.
次要结局
- 30-day PPA(At 3 and 6 months post randomization)
- 24 hour PPA(At 3, 6 and 12 months post randomization)
- 7 day PPA(At 3, 6 and 12 months post randomization)
- Cost per quitter(At 12 months post randomization)
- Cost per life year gained(At 12 months post randomization)
- Cost per quality-adjusted life year (QALY) gained(At 12 months post randomization)