Smartphone-delivered Scheduled Smoking With Compliance Facilitation as an Adjunct Cessation Therapy: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Application (App) Usability Questionnaire
研究概览
简要总结
To collect user experience data for a smartphone app that is designed to help people reduce or quit smoking and to learn if the app, combined with nicotine patches, can help people quit smoking.
详细描述
Objectives:
We propose to develop a mobile smoking intervention termed COmpliance-facilitated Scheduled Smoking Reduction (COSSR) delivered as a smartphone app. Through the proposed research as a pilot study, we want to identify the effect size of the proposed COSSR
intervention. We will pursue the following aims:
Aim 1:
Develop the COSSR app and evaluate the app's usability. In this aim, our first objective is to develop the COSSR app, and our second objective is to evaluate the app's usability, making sure that our app's core features are working, such as generating personalized smoking schedules, recording smoking, and taking carbon monoxide (CO) measures using the portable CO devices. We will recruit 15 participants from across the state of Texas to test our app for 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Age: 18 years old or older
- •Smoking: an average of 10 or more cigarettes, little cigars, or cigarillos combined per day within the past 30 days preceding the phone screen
- •Expired carbon monoxide (CO): > 6 ppm
- •Can install and run the study app on their Android smartphone, or agree to use the study smartphone loaned from the research team
- •Agree to return the study smartphone if the participant loans one from the research team
- •Willing to reduce smoking (Aim 1)
- •Seeking smoking cessation treatment (Aim 2)
- •Fluency in spoken and written English
- •Agree to be treated via telehealth (live audio-video conference and phone) and to be contacted via text and/or email
- •Provide informed consent and agree to all assessments and study procedures
- •Willing to refrain from the use of other nicotine/tobacco products for the duration of the study
- •Willing to refrain from the use of marijuana, prescription medications not prescribed to the participant, and illegal drugs
排除标准
- •Taking psychotropic, anticonvulsive, or narcotic medication
- •Meet criteria for a current major depressive episode or suicidality according to the PHQ (indicated by a score of 10 or higher).
- •Involved in current and imminent (within the next 45 days) smoking cessation activity
- •Women who are pregnant or breastfeeding
- •Shares the same address as a currently enrolled participant
- •Unwilling to use or allergic to nicotine patches (Aim 2)
- •Considered by the investigator to be an unsuitable or unstable candidate, such as those who appear to have cognitive impairment, and those who reside in a shelter, group/recovery facility, or treatment facility
- •Any plans to move out of the state in the next 6 months
- •Using marijuana, prescription medications not prescribed to the participant, and illegal drugs on a daily basis
- •Have experienced abnormal heart rhythms or cardiovascular disease, such as stroke, chest pain, and heart attack, in the last month (Aim 2)
研究组 & 干预措施
Part 1
Participants will use the app for 4 weeks, during which participants will follow a smoking schedule on the app to help you reduce your cigarette consumption
干预措施: Smart Phone App (Behavioral)
Part 2
Participants will also use the app for the duration of the study (about 3 months).
Participants will be asked to record your smoking using the app and complete online surveys
干预措施: Smart Phone App (Behavioral)
Part 1
Participants will use the app for 4 weeks, during which participants will follow a smoking schedule on the app to help you reduce your cigarette consumption
干预措施: NIcotine Patches (Other)
Part 2
Participants will also use the app for the duration of the study (about 3 months).
Participants will be asked to record your smoking using the app and complete online surveys
干预措施: NIcotine Patches (Other)
结局指标
主要结局
Application (App) Usability Questionnaire
时间窗: through completion of study; an average of 1 year.
Scale Scores (1-5) 1-strongly disagree, 2-disagree, 3-neither disagree nor agree, 4-agree and 5-strongly agree
次要结局
未报告次要终点