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临床试验/NCT02201810
NCT02201810已完成不适用

Enhancing the Efficacy of Smoking Quit Line in the Military

University of Virginia2 个研究点 分布在 1 个国家目标入组 614 人开始时间: 2015年5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
614
试验地点
2
主要终点
Effectiveness of randomized reengagement interventions

研究概览

简要总结

This study is a randomized clinical trial designed to measure the effectiveness of three QL interventions for smokers who failed to quit an initial smoking cessation intervention, but remain motivated to quit smoking.

详细描述

In the investigators' previous QL protocol, FWH20080093H, the investigators documented that a military-tailored QL was associated with high rates of sustained smoking cessation. The proactive QL produced superior cessation rates at a one year follow-up compared to a reactive QL. Unfortunately, even with high rates of cessation, a large number of participants (the majority of participants) fail to remain quit at follow-up. Civilian QLs have observed the same marked decay of sustained cessation rates from the end of treatment to the one year follow-up.

An opportunity exists to reengage these smokers who relapse or fail to quit by the end of QL treatment. Civilian QLs use one of two treatments, Recycling (repeat the smoking cessation counseling) or Rate Reduction (cut down over time), as the primary methods for treatment reengagement. Unfortunately, these methods of reengaging the relapsed/failed to quit smoker have not been systematically evaluated. As such, we propose to randomize participants who relapse or fail to quit by the end of the intervention to either (1) repeating the proactive QL (Recycle); (2) smoking reduction with the goal of eventual cessation (Rate Reduction); or (3) the choice of Recycle or Rate Reduction (Choice). Efficacy will be established by assessing both point prevalence and continuous abstinence at a 12 month follow-up.

All participants (approximately 1900) are consented to follow-up treatment reengagement since we do not know a priori who will quit and who will not quit/relapse. The investigators anticipate, based on the investigators' QL study that about 30% will quit and remain quit based on the eight-week proactive QL and about 70% will either not quit or relapse (n≈1300). Those that are smoking at the three-month follow-up are stratified (based on whether they quit and relapsed vs. not quitting at all in the Proactive QL based upon self-report) and randomized to the three treatment reengagement strategies (Recycle, Rate Reduction, or Choice), each one lasting 8 weeks. Then, at one year follow-up, the investigators will assess both point prevalence and continuous abstinence. Since we are intervening on those that initially failed to quit or relapsed, continuous abstinence will be defined from the point of the last treatment reengagement intervention (one year from that point).

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
Single (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

入选标准

  • To be included, individuals will be
  • Active Duty, Retired, or Dependent with Tricare benefits
  • Participants must be at least 18 years old
  • Smoked five or more cigarettes a day for at least one year
  • Live in the 48 contiguous states, Alaska or Hawaii
  • Participants must have the ability to understand consent procedures, and have access to a telephone for participation
  • Seriously thinking of quitting smoking cigarettes in the next 30 days

排除标准

  • Persons who have a known or unknown knowledge of an allergy or hypersensitivity to Nicotine Replacement Therapy (NRT)
  • Women who are pregnant, breastfeeding or planning to become pregnant during the next 12 months
  • Persons diagnosed with an unstable heart condition will be excluded as NRT is contraindicated in these groups

结局指标

主要结局

Effectiveness of randomized reengagement interventions

时间窗: From 3 months follow up to 1 year follow up

We will assess tobacco status (both 7-day point prevalence and continuous abstinence) at the follow-up period (one year after reengagement interventions are completed) to assess outcome.

次要结局

  • One-year outcome from the initially successful group that quit smoking(1-yr after initial randomization)

研究者

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

Melissa Little, PhD, MPH

Associate Professor, Department of Public Health Sciences

University of Virginia

研究点 (2)

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