Comparative Effectiveness of Mobile Health Smoking Cessation Approaches Among Underserved Patients in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,332
- 试验地点
- 1
- 主要终点
- Smoking Point-Prevalence Abstinence (PPA)
研究概览
简要总结
This study will evaluate the comparative effectiveness of three smoking cessation therapies: mobile health (mHealth) application iCanQuit, mHealth application iCanQuit + Motiv8, and the Florida quit line.
详细描述
The research team will recruit 1,332 adult patients who smoke from primary care clinics in North Central Florida, focusing on: (a) the relative effectiveness of the 3 treatments in adult patients who smoke cigarettes, in underserved urban and rural primary care settings. The team will assign patients by chance to one of the 3 treatments. Smoking cessation will be confirmed with a breath test (measured at 2, 6, and 12 months). The study will measure the effects of these treatments in based on gender, race, ethnicity, rurality, and social vulnerability; (b) their effects on patients' quality of life, self-confidence in quitting, and satisfaction with the treatments; and (c) their impact on patients' reported levels of motivation, commitment to values, and acceptance of triggers for smoking.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Randomized to one of the 3 study arms, using a 1:1:1 allocation scheme
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥21 years old
- •Referred by the provider via Ask-Advise-Connect
- •Receiving care at one of the participating clinics
- •Daily access to their own smart phone (the study team will provide assistance to patients without a phone to obtain one through aid programs for low-income patients)
- •No household members already enrolled
排除标准
- •Unstable medical or psychiatric illness
研究组 & 干预措施
iCanQuit
iCanQuit is a modern, cognitive behavioral treatment which promotes cessation through greater acceptance of triggers for smoking and commitment to personal values. It is a smart phone-based acceptance and commitment therapy (ACT). For patients randomized to the iCanQuit arm (444 total), research staff will assist in downloading the app onto the patient's phone.
干预措施: iCanQuit (Behavioral)
iCanQuit+Motiv8
Motiv8 is an internet-and smart phone-based contingency management (CM) intervention. Motiv8 verifies smoking status via a hand-held breath carbon monoxide (CO) monitor that is connected to a smart phone. For patients randomized to the iCanQuit+Motiv8 arm (444 total), research staff will assist in downloading the combined pp and connecting the iCO to the patient's phone. Smokers will also be asked to complete the first 4 iCanQuit modules, which contain exercises designed to prepare the users for their quit day. The end of the preparation phase will also mark each patient's quit date. During the intervention (7 weeks), participants will be considered abstinent from smoking if their breath CO sample is ≤ 5 ppm or if the CO value has decreased by 5% per hour from the last sample provided.
干预措施: iCanQuit+Motiv8 (Behavioral)
Florida quit line
The Florida quit line provides telephone counseling for smoking cessation. Patients randomized to the Florida quit line arm (444 total) will be enrolled after contact information is sent electronically.
干预措施: Florida quit line (Behavioral)
结局指标
主要结局
Smoking Point-Prevalence Abstinence (PPA)
时间窗: Month 6
negative CO breath sample ≤ 5 ppm using an iCO monitor, and self-reported abstinence from smoking in the last 7 days
次要结局
- Values(Months 2 and 6)
- Quality of Life and Well-Being(Baseline, and month 6)
- Smoking Prolonged Abstinence(Months 6 and 12)
- Smoking Point-Prevalence Abstinence (PPA)(Months 2 and 12)
- Treatment Satisfaction(Month 12)
- Self Efficacy(Baseline, and month 6)
- Acceptance(Months 2 and 6)
- Motivation(Months 2 and 6)