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临床试验/NCT05145738
NCT05145738已完成不适用

Pilot Testing a Computer Delivered Tobacco Cessation Intervention in Outpatient Clinical Settings: A Feasibility Study

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2021年12月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
2
主要终点
Percent of contacts made with community health worker

研究概览

简要总结

The investigators have developed a hybrid computer- and person-delivered intervention, called "C-Raven" for smoking cessation that is tailored to people with tobacco use in Baltimore City. The computer delivered component consists of two ~20 minute sessions on an iPad guided by Edna Poe, an interactive avatar. These sessions are followed by elective in vivo initiation of nicotine replacement therapy (NRT). Community health workers (CHWs) trained in smoking cessation and motivational interviewing provide 6 weeks of supportive follow up counseling. The investigators propose a pilot of the intervention package in the Tobacco Treatment and Lung Cancer Screening Clinic (TTLCSC) at Johns Hopkins Hospital, and the Johns Hopkins Broadway Center for Addiction, assessing feasibility and acceptability of using this tool in these clinical settings. In addition, the investigators will compare whether the use of a virtual counselor is associated with greater satisfaction and engagement with the program.

To this end, the investigators propose a two-arm randomized controlled trial, randomizing up to 90 individuals with tobacco use to the current CRAVEN program which includes a virtual counselor, to CRAVEN without a virtual counselor. Primary outcomes include intervention feasibility and acceptability. The investigators will secondarily examine uptake and maintenance of pharmacotherapy for tobacco cessation, readiness to quit smoking, and tobacco cessation (7 day abstinence) at 6 months, patient satisfaction by intervention arm and CHW engagement by intervention arm.

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
Triple (Care Provider, Investigator, Outcomes Assessor)

盲法说明

Care providers, investigators and outcome assessors will be blind to avatar versus no avatar conditions

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

  • Adults ≥18 years of age receiving care in one of the two specified clinics
  • Current daily smoker and has smoked >100 cigarettes in their lifetime
  • English speaking
  • Cognitively able to understand proposed research design

排除标准

  • Actively psychotic or other severe mental health symptoms
  • Any contraindication to NRT use
  • Hearing impaired (unable to listen to audio component of intervention)

结局指标

主要结局

Percent of contacts made with community health worker

时间窗: 3 months

Implementation will be assessed with percent of contacts made with community health worker.

Percent of persons agreeing to participate among those referred

时间窗: 3 months

Feasibility will be assessed with percent of persons agreeing to participate among those referred.

次要结局

  • Readiness to quit smoking as assessed by a visual analog scale(Immediately post intervention)
  • Smoking cessation as assessed by 7-day no tobacco use self report(3 months)
  • Uptake of pharmacotherapy as assessed by a yes/no response(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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