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临床试验/NCT03194958
NCT03194958已完成不适用

Helping the Poor Quit Smoking: Specialized Quitlines and Meeting Basic Needs

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 1,944 人开始时间: 2017年6月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,944
试验地点
1
主要终点
Abstinence 6-months

研究概览

简要总结

Using a 2x2 randomized factorial design, we will conduct a statewide field trial in Missouri to compare the relative and combined effects of these two strategies for augmenting an existing, evidence-based tobacco quitline program. Among 2000 low-income smokers, half will receive standard Missouri quitline services and half will receive new Specialized Quitline services targeted to this group. In each of these groups, half also will receive calls from a trained navigator to help them address unmet Basic Needs and the accompanying psychological distress that act as barriers to smoking cessation.

详细描述

2-1-1 information specialists will deliver standard service, then ask a random number of callers per day if they would be willing to answer a few health questions as part of a new 2-1-1 service. Callers eligible to receive the invitation to screen for study eligibility will be: Missouri residents, calling for themselves, English-speaking, and not in acute crisis. Eligible smokers will then be asked if they are willing to share their contact information with a research team conducting a study to help smokers quit. Smokers who agree to share their contact information will be considered "enrolled". Trained 2-1-1 operators will record all recruitment screening data in a secure electronic database that is shared with research staff. Research staff will attempt to reach enrolled smokers by phone by the next business day.

Alere, through the Missouri Tobacco Quitline, will provide quitline services to smokers in all study conditions. Contact information and study group assignment for smokers will be provided to Alere via secure data transfer.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Health Services Research
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

  • •18 years and older
  • •Missouri resident
  • •English speaking
  • •Not in crisis
  • •Smoke cigarettes every day of the week
  • •Planning to quit smoking in the next 30 days
  • •Comfortable receiving calls from smoking expert and project team
  • •Willing to provide phone numbers to be reached

排除标准

  • •Pregnant or planning to become pregnant in the next 3 months
  • •Currently breastfeeding
  • •Insurance through employer
  • •Currently enrolled in smoking quitline

研究组 & 干预措施

Standard Quitline

No Intervention

Participants will receive standard Missouri quitline services

Specialized Quitline

Experimental

Participants will receive an enhanced version of the standard quitline services

干预措施: Specialized Quitline (Behavioral)

Standard Quitline with Basic Needs Navigator

Experimental

Participants receive standard quitline services with navigator

干预措施: Basic Needs Navigator (Behavioral)

Specialized Quitline with Basic Needs Navigator

Experimental

Participants receive enhanced quitline services with navigator

干预措施: Basic Needs Navigator (Behavioral)

Specialized Quitline with Basic Needs Navigator

Experimental

Participants receive enhanced quitline services with navigator

干预措施: Specialized Quitline (Behavioral)

结局指标

主要结局

Abstinence 6-months

时间窗: 6 months post-baseline

Report 7-day point prevalence abstinence measured at 6-months post --baseline

次要结局

  • 24hr Quit Attempt(6 months post-baseline)
  • Abstinence 3-months(3 months post-baseline)

研究者

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

Matthew Kreuter

Associate Dean for Public Health; Director

Washington University School of Medicine

研究点 (1)

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