跳至主要内容
临床试验/NCT02478697
NCT02478697已完成不适用

Tobacco Treatment for Employable Californians (TTEC), Improving Employability Partnership: Alliance to Curb Tobacco (Total IMPACT)

Stanford University6 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
360
试验地点
6
主要终点
Smoking Status: 7-day point prevalence abstinence

研究概览

简要总结

Previous findings indicate elevated risk for tobacco use among adults in California who are unemployed and seeking work. In a pilot study, tobacco use was associated with a longer duration of time out of work. This community-based participatory research study aims to deliver and evaluate the impact of a web-based job seeker tailored tobacco cessation intervention vs. a control group in the San Francisco Bay Area. This research investigates whether an employment-centered tobacco treatment intervention is efficacious in supporting abstinence and also associated with more timely engagement of employment.

详细描述

PLEASE NOTE: The grant for this project was approved under the title "Tobacco Treatment for Employable Californians," abbreviated "TTEC."

However, as this study is being run under the principles of community- based participatory research, the Stanford team provided the community advisors and representatives of the recruitment sites the opportunity to create a name they felt better conveyed the interests and goals of the study to potential participants. As such, the term Total IMPACT Study is used on all participant-facing materials.

Dr. Prochaska will oversee study procedures for participant recruitment, informed consent, data collection, analysis, and dissemination. IRB approved study flyers and e-communications will promote the study with a central study contact phone number and email address held by the study coordinator. The study will follow the Dillman method for electronic communications inviting and encouraging potential respondents to participate. For systematic data collection and storage, all assessments will be conducted using Qualtrics or RedCap for online data collection with data encryption for added security protection.

Face-to-face informed consenting procedures occur onsite at the employment agencies. Some participants may call in and get preliminarily screened for eligibility over the phone, but will be directed to meet with on-site staff to begin the consent process. Hired and trained field research study staff will be recent job-seeking clients from the agencies who will complete the informed consenting procedures with participants, obtain collateral contact information for follow-up contacts, and provide participants with a study ID code and the website URL for completing the online survey. The collateral contact information will be used if research staff cannot reach the participant directly. Study staff may ask collateral contacts for updated contact information as well as updated smoking and/or employment status (e.g., "Has [name] been smoking recently?" "Do you know if [name] is currently working?)

Study eligibility will be defined as unemployed and job seeking at a participating America's Job Centers of California (AJCC) organization and currently smoking 1 or more cigarettes daily and at least 100+ cigarettes in one's lifetime with a carbon monoxide (CO) breath sample of 10 ppm or greater. The CO sample will be taken prior to consenting potential participants. Participants must be 18 years or older, English literate, able to provide at least three collateral sources of contact for follow-up assessments, and not immediately planning to relocate out of California (though researchers would continue to follow-up with participants who move out of area, and the research team has demonstrated success with doing so in prior studies). Dual use of e-cigarettes will not be an exclusion criterion.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

入选标准

  • Study eligibility will be defined as unemployed and job seeking at a participating America's Job Centers of California (AJCC) organization and currently smoking 1 or more cigarettes daily and at least 100+ cigarettes in one's lifetime with a carbon monoxide (CO) breath sample of 10 ppm or greater. The CO sample will be taken prior to consenting potential participants. Participants must be 18 years or older, English literate, able to provide at least three collateral sources of contact for follow-up assessments, and not immediately planning to relocate out of California (though researchers would continue to follow-up with participants who move out of area, and have demonstrated success with doing so in prior studies). Dual use of e-cigarettes will not be an exclusion criterion.

排除标准

  • Failure to meet inclusion criteria; non-job-seeking, persons employed or underemployed, occasional/non-daily smokers, daily smokers with carbon monoxide readings less than 10ppm, nonsmokers.

结局指标

主要结局

Smoking Status: 7-day point prevalence abstinence

时间窗: 6-months follow-up

Past 7-day use of conventional cigarettes, alternative tobacco (smokeless, snus), and electronic nicotine devices (ENDS, e.g., e-cigarettes) with details on cigarettes/day, frequency, brand, flavor, strength, and quit attempts. For biochemical verification, participants reporting 7-day PPA at follow-up will have an expired CO sample evaluated using a Bedfont Smokerlyzer. Participants with CO \< 8 ppm indicating nonsmoking will provide a saliva sample for testing with of cotinine with an Accutest? NicAlertTM test strip. Salivary cotinine levels \< 15 ng/ml will confirm nonsmoking. Additionally, participants reporting being quit will be asked to provide a urine sample to test for the presence of anabasine (if they have quit smoking but are still using nicotine replacement or another nicotine containing product).

Time to find employment (weeks)

时间窗: 6-months

How quickly participants find employment, measured in weeks

次要结局

  • Employment Status - Within study period(6-months follow-up)
  • Employment Status(3-months follow-up)
  • 3-month Prolonged Abstinence(6-months follow-up)
  • Employment Status - Current(6-months follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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