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临床试验/NCT03643679
NCT03643679终止不适用

Tobacco Cessation for Sexual Minorities

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2018年10月4日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
32
试验地点
2
主要终点
Helpfulness, frequency of use, and ease of use of the intervention smartphone app

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Already receiving pharmacological and/or behavioral intervention or counseling for smoking cessation

结局指标

主要结局

Helpfulness, frequency of use, and ease of use of the intervention smartphone app

时间窗: 1-month and 3-month

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. 1. How helpful was the Kwit app? 2. Was the app easy to use? 3. Was it frustrating to use? Responses for 1-3 will be limited to Very helpful, Somewhat helpful, Neutral, Not very helpful, Not at all helpful 4. What, if anything, was helpful about the app? What, if anything, was not helpful about the app? 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.

次要结局

  • Cessation (self-report)(1-month and 3-month)
  • Cessation (bio-chemical)(1-month and 3-month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kar-Hai Chu

Assistant Professor of Medicine

University of Pittsburgh

研究点 (2)

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