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临床试验/NCT05649241
NCT05649241已完成不适用

Testing the Efficacy, Feasibility and Acceptability of a Pharmacist-Delivered Medication Therapy Management Approach to Smoking Cessation for Rural Smokers in Appalachia

University of Virginia1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年8月31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
24
试验地点
1
主要终点
Retention

研究概览

简要总结

Adult smokers were recruited through an independent pharmacy in rural Appalachia and were randomized to 1 of 8 treatments, including medication and/or therapy from the pharmacist, to help quit smoking.

详细描述

24 adult smokers were recruited through an independent pharmacy in rural Appalachia were randomized to 1 of 8 treatments: (1) pharmacist delivered QuitAid intervention (Yes vs. No), (2) Combination NRT Gum + NRT Patch (vs. NRT patch), and/or (3) 8 weeks of NRT (vs. standard 4 weeks). All participants received 4 weeks of NRT patch in addition to the components to which they were assigned. Participants completed baseline and 3-month follow-up assessments. The primary outcomes were feasibility of recruitment and randomization, retention, treatment adherence and fidelity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
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

  • smokers must have smoked at least 5 cigarettes per day for the past 6 months
  • be willing to set a quit date in the next 30 days
  • own a cell phone
  • be over 18 years of age
  • not be pregnant or planning to become pregnant in the next 6 months
  • not have any medical contraindications to using NRT

排除标准

  • Those who are pregnant or plan to be
  • Those under 18 years of age
  • Those with a medical contradiction
  • Those who do not own a cell phone
  • Those who have not smoked 5 cigarettes per day for the last 6 months
  • Those who are unwilling to set a quit date within 30 days

研究组 & 干预措施

QuitAid, 8 weeks, Patch + Gum

Experimental

Participants received QuitAid, a medication therapy management delivered by their pharmacists and 8 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch and the NRT Gum

干预措施: Nicotine patch (Drug)

QuitAid, 8 weeks, Patch + Gum

Experimental

Participants received QuitAid, a medication therapy management delivered by their pharmacists and 8 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch and the NRT Gum

干预措施: Nicotine gum (Drug)

QuitAid, 4 weeks, Patch + Gum

Experimental

Participants received QuitAid, a medication therapy management delivered by their pharmacists and 4 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch and the NRT Gum

干预措施: Nicotine patch (Drug)

QuitAid, 8 weeks, Patch + Gum

Experimental

Participants received QuitAid, a medication therapy management delivered by their pharmacists and 8 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch and the NRT Gum

干预措施: Medication Therapy Management (Behavioral)

QuitAid, 4 weeks, Patch + Gum

Experimental

Participants received QuitAid, a medication therapy management delivered by their pharmacists and 4 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch and the NRT Gum

干预措施: Nicotine gum (Drug)

QuitAid, 4 weeks, Patch + Gum

Experimental

Participants received QuitAid, a medication therapy management delivered by their pharmacists and 4 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch and the NRT Gum

干预措施: Medication Therapy Management (Behavioral)

QuitAid, 8 weeks, Patch

Experimental

Participants received QuitAid, a medication therapy management delivered by their pharmacists and 8 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch

干预措施: Nicotine patch (Drug)

QuitAid, 8 weeks, Patch

Experimental

Participants received QuitAid, a medication therapy management delivered by their pharmacists and 8 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch

干预措施: Medication Therapy Management (Behavioral)

QuitAid, 4 weeks, Patch

Experimental

Participants received QuitAid, a medication therapy management delivered by their pharmacists and 4 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch

干预措施: Nicotine patch (Drug)

QuitAid, 4 weeks, Patch

Experimental

Participants received QuitAid, a medication therapy management delivered by their pharmacists and 4 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch

干预措施: Medication Therapy Management (Behavioral)

No QuitAid, 8 weeks, Patch + Gum

Experimental

Participants received 8 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch and the NRT Gum

干预措施: Nicotine patch (Drug)

No QuitAid, 8 weeks, Patch + Gum

Experimental

Participants received 8 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch and the NRT Gum

干预措施: Nicotine gum (Drug)

No QuitAid, 4 weeks, Patch + Gum

Experimental

Participants received 4 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch and the NRT Gum

干预措施: Nicotine patch (Drug)

No QuitAid, 4 weeks, Patch + Gum

Experimental

Participants received 4 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch and the NRT Gum

干预措施: Nicotine gum (Drug)

No QuitAid, 8 weeks, Patch

Experimental

Participants received 8 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch

干预措施: Nicotine patch (Drug)

No QuitAid, 4 weeks, Patch

Experimental

Participants received 4 weeks of Nicotine Replacement Therapy (NRT) in the form of the NRT Patch

干预措施: Nicotine patch (Drug)

结局指标

主要结局

Retention

时间窗: 3 months

Retention was assessed by the proportion of smokers who completed the 3-month follow-up.

Feasibility of recruitment

时间窗: 3 months

Feasibility of recruitment was measured by (a) the proportion of smokers recruited from each source (e.g., ask-advise-connect, posters, prescription bag advertisements) and (b) the number recruited per month.

Feasibility of randomization

时间窗: 3 months

Feasibility of randomization was determined by the number of smokers that were approached and screened in order to randomize 24 smokers (e.g., ineligible smokers, smokers that do not consent).

次要结局

  • Tobacco Use(3 months)

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 (1)

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