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临床试验/NCT05227027
NCT05227027已完成不适用

Influence of a Game Embedded in a Smartphone App for Smoking Cessation on User Engagement: A Randomized Pilot Trial

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2022年2月9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
500
试验地点
1
主要终点
Number of Unique App Sessions

研究概览

简要总结

This study evaluates the effects of a video game embedded in a commercially available mobile application (app) for smoking cessation. Smokers are increasingly turning to mobile health apps for assistance with quitting smoking, and there is a critical need for strategies to engage app users to increase retention and efficacy. Video games are designed to increase users' motivation and engagement, which in turn may increase their exposure and adherence to a smoking cessation program. The hypothesis is that the game increases engagement, retention, and smoking abstinence rates compared with a core version of the app without the game. A two-arm individually randomized pilot trial of 500 adult smokers will test this hypothesis, comparing outcomes for participants randomized to receive the core app plus embedded game with participants randomized to receive the core app only. Primary outcomes relate to user engagement with the app. Secondary outcomes relate to user engagement, efficacy (smoking abstinence), and user satisfaction.

详细描述

PRIMARY OBJECTIVES:

I. Augment an existing smartphone cessation app for smoking cessation with a video game to increase user engagement.

II. Test the feasibility, engagement, and early efficacy of the 'gamified' app, compared to one without gamification.

OUTLINE:

Participants are recruited through the Smoke Free smartphone app and randomized to 1 of 2 arms.

研究设计

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

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Education module only

Active Comparator

Participants receive an educational intervention through the Smoke Free application only (core app only). Participants complete questionnaires and may undergo saliva sample collection, if they report being smoke-free on follow-up.

干预措施: Smoke Free smartphone application (Behavioral)

Education plus game module

Experimental

Participants receive an educational intervention through the Smoke Free application with the embedded game module. Participants complete questionnaires and may undergo saliva sample collection, if they report being smoke-free on follow-up.

干预措施: Smoke Free smartphone application (Behavioral)

Education plus game module

Experimental

Participants receive an educational intervention through the Smoke Free application with the embedded game module. Participants complete questionnaires and may undergo saliva sample collection, if they report being smoke-free on follow-up.

干预措施: Game Module (Behavioral)

结局指标

主要结局

Number of Unique App Sessions

时间窗: Enrollment through 56 days after participant's selected quit date (56 to 63 days total)

Number of times the app was opened; passively collected by the app and averaged in analysis to calculate mean number of app opens by study group over the study period. A new session is defined as use of the app after at least 30 minutes of inactivity.

Minutes of App Usage Per Session

时间窗: Enrollment through 56 days after participant's selected quit date (56 to 63 days total)

Passively collected by the app and averaged in analysis among those with a session to calculate mean number of minutes of usage per session by study group.

次要结局

  • Unique Days With at Least One App Session(Enrollment through 56 days after participant's selected quit date (56 to 63 days total))
  • Self-reported 7-day Point-prevalence Abstinence at 2 Months(56 days after participant's selected quit date (56 to 63 days after enrollment))
  • Self-reported 30-day Point-prevalence Abstinence at 2 Months(56 days after participant's selected quit date (56 to 63 days after enrollment))
  • Satisfaction With App(56 days after participant's selected quit date (56 to 63 days after enrollment))
  • Satisfaction With Game (Intervention Group Only)(56 days after participant's selected quit date (56 to 63 days after enrollment))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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