Social Media Technology for Treating Tobacco Addiction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 980
- 试验地点
- 2
- 主要终点
- Percentage of Participants With a 6-month Sustained Abstinence
研究概览
简要总结
Tweet2Quit is an innovative smoking cessation intervention that combines real-time online peer-to-peer support with auto messaging. In a three-group randomized controlled trial, the investigators will compare: 1) usual care, 2) Tweet2Quit-coed, and 3) Tweet2Quit-Women only.
详细描述
The proposed randomized controlled evaluation of the Tweet2Quit intervention will biochemically verify abstinence out to 6-months follow-up and will test the personalized benefit for women of a women-only versus co-ed Tweet2Quit group. In a 3-arm design, the investigators will compare: 1) usual care, 2) Tweet2Quit-coed, and 3) Tweet2Quit-Women only.
Each Tweet2Quit group will include buddy pairs based on similarity in demographics. Also automated pattern detection will identify dips in tweeting and trigger automated alerts and engagement strategies.
The sample consists of 960 adult smokers plus 20 in an initial pilot group to check technology functionality (not included in outcome assessment).
The primary aims test Hypothesis 1: Relative to usual care (n=240), Tweet2Quit-coed groups (n=480) will achieve significantly greater bioconfirmed sustained abstinence out to 6-months follow-up for each gender, and Hypothesis 2: Women in Tweet2Quit will achieve significantly greater bioconfirmed 6-months abstinence in woman-only groups (n=240) vs. coed groups (n=240 women).
Our secondary aims are to test the same hypotheses based on 3-month (end of treatment) sustained abstinence and 7-day point prevalence at 1, 3, and 6 months with biochemical verification at 3 and 6 months. Exploratory aims will study the Tweet2Quit groups' social network structures with a focus on the identification of buddy pairs and social brokers and test if these relationships are stronger for women in women-only groups versus women in coed groups of Tweet2Quit.
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
- 21 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are 21-59 years of age
- •Are smoking 5+ cigarettes/day and 100+ cigarettes in one's lifetime
- •In the preparation stage of quitting smoking
- •Are English speaking
- •Have a mobile phone with an unlimited texting plan and internet access (via mobile phone)
- •Text at least once a week
- •Are a social media user
- •Have an active email account
- •Lives in the continental USA
排除标准
- •Have certain medical conditions that are contraindicated for nicotine replacement therapy: pregnant, breast feeding, a recent heart attack, an irregular heartbeat, high blood pressure not controlled with medication, skin allergies to adhesive tape or serious skin problems, taking a prescription medicine for depression, and/or any other medical conditions that would prevent you from completing this study.
- •Are an illicit hard drug user or regular marijuana user
- •Share a household with someone else or has an immediate family member who has already enrolled in the study currently or in the past or if the participant has already been enrolled or failed to pass the screening once already since October 2016
- •Participated in Tweet2Quit between 2012-2013 in a Twitter group and was not an active tweeter (<1 week)
- •Fails to provide valid forms of all the required personal contact information
研究组 & 干预措施
NRT + Web Guide
NCI Smokefree.gov plus 8 weeks of combination NRT (nicotine patch plus gum/lozenges)
干预措施: NRT (Drug)
NRT + Web Guide
NCI Smokefree.gov plus 8 weeks of combination NRT (nicotine patch plus gum/lozenges)
干预措施: Web Guide (Behavioral)
NRT + Web Guide + Tweet2Quit-Coed
NCI Smokefree.gov plus 8 weeks of combination NRT (nicotine patch plus gum/lozenges) plus assignment to a coed Tweet2Quit group
干预措施: NRT (Drug)
NRT + Web Guide + Tweet2Quit-Coed
NCI Smokefree.gov plus 8 weeks of combination NRT (nicotine patch plus gum/lozenges) plus assignment to a coed Tweet2Quit group
干预措施: Web Guide (Behavioral)
NRT + Web Guide + Tweet2Quit-Coed
NCI Smokefree.gov plus 8 weeks of combination NRT (nicotine patch plus gum/lozenges) plus assignment to a coed Tweet2Quit group
干预措施: Tweet2Quit (Behavioral)
NRT + Web Guide + Tweet2Quit-Women
Experimental: NRT + Web Guide + Tweet2Quit-Women NCI Smokefree.gov plus 8 weeks of combination NRT (nicotine patch plus gum/lozenges) plus assignment to a women-only Tweet2Quit group
干预措施: NRT (Drug)
NRT + Web Guide + Tweet2Quit-Women
Experimental: NRT + Web Guide + Tweet2Quit-Women NCI Smokefree.gov plus 8 weeks of combination NRT (nicotine patch plus gum/lozenges) plus assignment to a women-only Tweet2Quit group
干预措施: Web Guide (Behavioral)
NRT + Web Guide + Tweet2Quit-Women
Experimental: NRT + Web Guide + Tweet2Quit-Women NCI Smokefree.gov plus 8 weeks of combination NRT (nicotine patch plus gum/lozenges) plus assignment to a women-only Tweet2Quit group
干预措施: Tweet2Quit (Behavioral)
Initial Pilot Group (NRT + Web Guide + Tweet2Quit-Coed)
The initial pilot group was run to check technology functionality and user acceptance; it was not included in outcome assessments. These participants received NCI Smokefree.gov plus 8 weeks of combination NRT (nicotine patch plus gum/lozenges) plus assignment to a coed Tweet2Quit group.
干预措施: NRT (Drug)
Initial Pilot Group (NRT + Web Guide + Tweet2Quit-Coed)
The initial pilot group was run to check technology functionality and user acceptance; it was not included in outcome assessments. These participants received NCI Smokefree.gov plus 8 weeks of combination NRT (nicotine patch plus gum/lozenges) plus assignment to a coed Tweet2Quit group.
干预措施: Web Guide (Behavioral)
Initial Pilot Group (NRT + Web Guide + Tweet2Quit-Coed)
The initial pilot group was run to check technology functionality and user acceptance; it was not included in outcome assessments. These participants received NCI Smokefree.gov plus 8 weeks of combination NRT (nicotine patch plus gum/lozenges) plus assignment to a coed Tweet2Quit group.
干预措施: Tweet2Quit (Behavioral)
结局指标
主要结局
Percentage of Participants With a 6-month Sustained Abstinence
时间窗: 6 Month
Percentage of participants who reported no use of tobacco products by answering the questions: 'How many cigarettes have you smoked', 'How many other tobacco products have you used', and 'How many times have you used e-cigs' since the quit date (assessed at 1, 3 and 6 months post quit date) confirmed by salivary cotinine measurement (assessed at 3 and 6 months post quit date). Note: We will apply the Russell Standard for abstinence, allowing 5 or fewer instances of tobacco use over 6 months. In our primary (most rigorous) analysis, we will consider a cotinine-positive test, regardless of source, to be non-abstinent. In additional analyses, we will code as abstinent those who assert tobacco abstinence but continue use of FDA-approved nicotine replacement therapy. In other analyses we will report results with ENDS-only users coded first as non-abstinent and then for comparison as abstinent.
次要结局
未报告次要终点
研究者
Cornelia Pechmann
Principle Investigator
University of California, Irvine