Tobacco Cessation for Sexual Minorities
There is a growing body of evidence revealing disproportionately higher rates of tobacco use among sexual and gender minority (SGM) individuals, compared to their heterosexual peers. These disparities have led organizations to support the inclusion of SGM in all local, state, and national tobacco prevention and control activities. In an attempt to leverage the online milieu for health-related interventions, mobile apps have been created to support tobacco cessation. However, evidence-based apps promoted by the National Cancer Institute are unpopular, remain poorly supported, and were not studied for use by SGM persons. Commercial apps, on the other hand, have been downloaded millions of times, contain many valuable features, and enjoy better infrastructure. Unfortunately, they are not evidence-based and have not been rigorously tested.
The University of Pittsburgh (Pitt) is currently conducting a randomized controlled trial to assess the feasibility and efficacy of using the Kwit tobacco cessation app with patients at UPMC Montefiore and Presbyterian hospitals (PI: Chu). It is a pragmatic clinical trial applying a patient-centered outcomes framework to ensure that-rather than focusing only on successful cessation-the study includes measurements for quality of life, mobility, and social interactions. We propose to extend the study to underrepresented SGM young adults.
Survey measures will be adapted as needed to address issues specific to the SGM population.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15213
- University of Pittsburgh
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age 18-30
- Self-identified as a sexual minority (gay, lesbian, bisexual)
- Smokers interested in cessation (>1 cigarettes/day over the past 30 days)
- Must own an Apple or Android based smartphone.
Exclusion Criteria:
- Already receiving pharmacological and/or behavioral intervention or counseling for smoking cessation
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Kwit smartphone app
This arm will receive the Kwit smartphone app.
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The Kwit smartphone app combines several popular features of tobacco cessation apps, including game-like features (e.g., unlocking achievement milestones for completing cessation-related tasks), useful statistics (e.g., money saved), and an ability to share progress with friends.
Users can actively engage with the app to track cravings or view progress, such as life expectancy gained.
A passive component notifies users when milestones have been achieved, e.g., when blood no longer contains nicotine.
Motivational messages can be actively requested at any time; they can also appear unsolicited, as when the user logs cravings.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Helpfulness, frequency of use, and ease of use of the intervention smartphone app
大体时间：1-month and 3-month
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Assessment of feasibility: Two follow-up surveys will be administered: the first, 1-month after recruitment,and the second, 3 months after recruitment. Surveys will be administered in-person. Specific questions will be asked to rate the Kwit smartphone application's feasibility, based on a combination of helpfulness, frequency of use, and ease of use. Frustrations and helpful aspects of the application will be assesses qualitatively.
Each of these responses (Q1-3) will be combined to report a single overall feasibility value. Qualitative data (Q4) will be used to modify scores as needed. |
1-month and 3-month
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Cessation (self-report)
大体时间：1-month and 3-month
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Descriptive statistics will be used to assess cessation outcomes. The information will be obtained via two follow-up surveys (1 month and 3 months after recruitment), with specific questions pertaining to the level of participant smoking as well as their confidence levels on maintaining cessation.
The overall assessment of cessation will be primarily based on the 7-day item. |
1-month and 3-month
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Cessation (bio-chemical)
大体时间：1-month and 3-month
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Cessation will also be verified by a breath analysis monitor.
The information will be obtained during each follow-up.
Biochemical verification will be based on a 10 COppm cutoff to determine whether or not the participant has successfully quit tobacco.
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1-month and 3-month
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- PRO18050656
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Kwit smartphone app的临床试验
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University of WashingtonNational Institute of Dental and Craniofacial Research (NIDCR)邀请报名
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Medical University of South CarolinaNational Cancer Institute (NCI)完全的
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Research Center for Clinical Neuroimmunology and...Hoffmann-La Roche; Novartis Pharmaceuticals; University Hospital, Basel, Switzerland; University... 和其他合作者主动，不招人