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临床试验/NCT06088498
NCT06088498进行中(未招募)2 期

Augmented Reality as an Adjunct to Quitline Counseling for Smoking Cessation

H. Lee Moffitt Cancer Center and Research Institute2 个研究点 分布在 1 个国家目标入组 1,051 人开始时间: 2024年6月11日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
进行中(未招募)
入组人数
1,051
试验地点
2
主要终点
Tobacco Abstinence (Aim 2)

研究概览

简要总结

The overall goal of the study is to assess the efficacy of using cue exposure delivered via a smartphone application as an adjunct to Tobacco Quitline treatment to improve smoking abstinence.

详细描述

The aims of the study are: (1) to update a recently developed study-related smartphone application to reduce cravings to smoke to be an engaging, user-friendly treatment tool, and verify user satisfaction; and (2) to test in a randomized controlled trial the efficacy of the app as an adjunct to quitline smoking cessation treatment in improving smoking abstinence compared to the quitline only.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

The statistician is masked

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

  • >18 years of age
  • Daily smokers that have quit smoking within the past 3 months (Aim 1) or currently smoking ≥ 3 cigarettes per day for the past year (Aim 2)
  • Functioning telephone number
  • Owns a smart phone capable of supporting AR and willing to download the app
  • Can speak, read and write in English

排除标准

  • Has another household member already enrolled in the study

研究组 & 干预措施

Aim 1: Update an existing smartphone App

Experimental

An existing study app will be updated to be engaging, user-friendly treatment tool, and verify user satisfaction.

干预措施: Quitline Services and Smartphone App (Behavioral)

Aim 2: Quit Line Only

Experimental

Participants randomized to this arm will receive usual care for smoking cessation via the quitline and a smartphone app that will allow them to track smoking urges and abstinence.

干预措施: Quitline Services (Behavioral)

Aim 2:Quitline plus smartphone App

Experimental

Participants randomized to this arm will receive usual care for smoking cessation via the quitline and a smartphone app that will allow them to track smoking urges and abstinence. After 48 hours of self-reported abstinence, they will be exposed to smoking extinction trials through the study smartphone app.

干预措施: Updating Existing Smartphone App (Behavioral)

Aim 2:Quitline plus smartphone App

Experimental

Participants randomized to this arm will receive usual care for smoking cessation via the quitline and a smartphone app that will allow them to track smoking urges and abstinence. After 48 hours of self-reported abstinence, they will be exposed to smoking extinction trials through the study smartphone app.

干预措施: Quitline Services (Behavioral)

Aim 2:Quitline plus smartphone App

Experimental

Participants randomized to this arm will receive usual care for smoking cessation via the quitline and a smartphone app that will allow them to track smoking urges and abstinence. After 48 hours of self-reported abstinence, they will be exposed to smoking extinction trials through the study smartphone app.

干预措施: Quitline Services and Smartphone App (Behavioral)

结局指标

主要结局

Tobacco Abstinence (Aim 2)

时间窗: At 6 Months

Self-report of no combustible tobacco use in the past 7 days

System Usability Scale (Aim 1)

时间窗: At 1 Week

Participants' perception of usability and learnability of the app will be measured using 10 items on a 5-point Likert scale. Scores range from 0 to 100, with higher scores indicating better usability.

次要结局

  • User Satisfaction (Aim 1)(At 1 Week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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