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临床试验/NCT05327660
NCT05327660已完成1 期

Remote Carbon Monoxide Monitoring and Incentives for Tobacco Cessation in Quitlines

Consumer Wellness Solutions1 个研究点 分布在 1 个国家目标入组 229 人开始时间: 2021年12月31日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
229
试验地点
1
主要终点
Treatment Satisfaction

研究概览

简要总结

The present study is a 3-arm randomized controlled pilot study. Participants who call the Maryland Tobacco Quitline and are eligible for study participation are randomized to receive quitline tobacco cessation treatment as usual (TAU), TAU plus remote carbon monoxide (CO) monitoring via smartphone app, or TAU plus remote carbon monoxide monitoring plus incentives vis smartphone app. The investigators hypothesize that remote CO monitoring will be feasible and acceptable to deliver in the quitline setting, will increase treatment engagement, and will increase tobacco cessation and treatment satisfaction rates.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Daily cigarette smokers calling into participating quitlines
  • •18 year or older
  • •Reads and speaks English
  • •Has a smartphone with a data plan
  • •Willing to download and use study app
  • •Willing to use CO monitor

排除标准

  • •Pregnant or breast feeding

研究组 & 干预措施

Quitline treatment as usual (TAU)

Active Comparator

Quitline services provided by participating state quitlines

干预措施: Quitline Treatment as Usual (TAU) (Combination Product)

Quitline TAU plus remote CO monitoring

Experimental

Quitline service plus daily CO monitoring via a smartphone app

干预措施: Quitline Treatment as Usual (TAU) (Combination Product)

Quitline TAU plus remote CO monitoring

Experimental

Quitline service plus daily CO monitoring via a smartphone app

干预措施: Remote Carbon Monoxide (CO) Monitoring (Combination Product)

Quitline TAU plus incentivized remote CO monitoring

Experimental

Quitline TAU plus remote CO monitoring with small monetary incentives

干预措施: Quitline Treatment as Usual (TAU) (Combination Product)

Quitline TAU plus incentivized remote CO monitoring

Experimental

Quitline TAU plus remote CO monitoring with small monetary incentives

干预措施: Incentivized Remote CO Monitoring (Combination Product)

结局指标

主要结局

Treatment Satisfaction

时间窗: 60 days

Rating of satisfaction with quitline services on a 6-point scale collected via follow-up survey. Five questions were internally developed to determine satisfaction with the quitline services provided where low numbers (1-3) mean dissatisfaction and high numbers (4-6) mean satisfaction. Participants that reported a score of 4 (somewhat satisfied) or more are represented in the data table.

Treatment Engagement

时间窗: 60 days

Number of quitline calls each participant engages in, collected via clinical record system.

Self-reported Tobacco Abstinence

时间窗: 60 days

7 day point prevalence abstinence from all combustible tobacco collected via follow-up survey

次要结局

  • Biochemically Verified Tobacco Abstinence(60 days)
  • Engagement With CO Monitor(60 days)
  • Satisfaction With CO Monitor(60 days)

研究者

发起方
Consumer Wellness Solutions
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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CO Monitoring for Tobacco Cessation in Quitlines | 临床试验