COach2Quit TRIAL: Assessing a Prototype Personal Carbon Monoxide Monitor for Smoking Cessation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Smoking Status Using a Point of Care Test for Measuring Carbon Monoxide (CO)
研究概览
简要总结
The objective of this study is to conduct a randomized controlled trial to determine whether the use of the COach2Quit application (app) reduces smoking more than brief advice for smoking cessation. The investigators hypothesize that real time biomarker feedback and messaging support from the COach2Quit app will lead to greater smoking cessation rates than brief anti-smoking advice alone. If effective, the COach2Quit app could be an easily accessible and cost-effective tool to help smokers quit. The findings from this trial could have implications for the delivery of future outpatient smoking cessation programs.
详细描述
The goal of this randomized controlled trial is to assess the efficacy of the novel COach2Quit smartphone application by determining whether the use of this app reduces smoking more than brief anti-smoking advice alone. This will be a two-arm individually randomized trial and participants who are currently smoking will be assigned 1:1 to either study arm. Smoking behavior will be measured through self-report at baseline, 2-week and 1-month follow up visits. Smoking behavior will also be verified by 2 biomarker measurements: carbon monoxide breath test and urine cotinine, collected at baseline, 2-week and 1-month follow-up visits. In addition, participants will receive weekly follow-up calls. The primary outcome will be smoking cessation at the 1-month follow-up visit.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age
- •current, daily smokers
- •agree to participate and anticipate to be living in Baltimore for at least 2 months
- •own a phone that is compatible with the app
- •be willing to set at baseline assessment a quit date within 2 weeks
排除标准
- •are suffering from any unstable medical condition precluding the use of the CO monitor (e.g. severe COPD)
- •are currently using smokeless tobacco including e-cigarettes
- •are currently using nicotine replacement therapy or other smoking cessation treatment
- •are pregnant, determined by participant self-report
- •have a negative baseline result on both urine cotinine AND CO monitor
研究组 & 干预措施
Control
A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute (NCI) 5 A's model.
干预措施: Cessation counseling (Behavioral)
COach2Quit
A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute's 5 A's model.
Participants in the COach2Quit arm will be provided with an individualized carbon monoxide (iCO) monitor along with instructions on the use of the monitor and the COach2Quit application.
干预措施: Individualized carbon monoxide (iCO) monitor (Device)
COach2Quit
A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute's 5 A's model.
Participants in the COach2Quit arm will be provided with an individualized carbon monoxide (iCO) monitor along with instructions on the use of the monitor and the COach2Quit application.
干预措施: COach2Quit smartphone application (Other)
COach2Quit
A certified smoking cessation interventionist (SCI) will deliver standardized smoking cessation counseling using the National Cancer Institute's 5 A's model.
Participants in the COach2Quit arm will be provided with an individualized carbon monoxide (iCO) monitor along with instructions on the use of the monitor and the COach2Quit application.
干预措施: Cessation counseling (Behavioral)
结局指标
主要结局
Smoking Status Using a Point of Care Test for Measuring Carbon Monoxide (CO)
时间窗: 1 month
A point of care test for measuring carbon monoxide (CO) will be conducted via the piCO Smokerlyzer from OPS Medical, designed specifically for smoking cessation programs and tobacco control programs. Carbon monoxide will be measured in an exhaled breath in parts-per-million (ppm). A reading of ≤ 10ppm will indicate abstinence.
Number of Participants With Color Change for Urine Test for Measuring Cotinine
时间窗: 1 month
A point of care urine test for measuring cotinine will also be conducted via the SmokeScreen® test from GFC Diagnostics Ltd. to verify smoking status. A color change to red/orange indicates a positive sample, with a darker color indicating greater nicotine intake.
次要结局
- Reasons for Quitting Scale(baseline)