Clinical trial NCT05227027: Pilot Trial of a Game Embedded in a Smartphone App for Smoking Cessation
Official title: Influence of a Game Embedded in a Smartphone App for Smoking Cessation on User Engagement: A Randomized Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking-Related Carcinoma
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institute on Aging (NIA)
name: University of California, Berkeley
name: Johns Hopkins University
First posted: 2022-02-07
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

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

ARM II: Participants receive an educational intervention through the Smoke Free application without the video game module (core app only). Participants complete questionnaires and may undergo saliva sample collection, if they report being smoke-free on follow-up.

Eligibility criteria: Inclusion criteria:

1. Provides electronic informed consent.
2. Male or female, aged 18 and older
3. Has downloaded and opened the Smoke Free app
4. A smoker of at least 1 cigarette per day
5. Plans to quit smoking within the next 7 days
6. Speaks, reads, and writes English
7. Lives in the United States

Exclusion criteria: None

Primary outcomes:
measure: Number of Unique App Sessions
timeFrame: Enrollment through 56 days after participant's selected quit date (56 to 63 days total)
measure: Minutes of App Usage Per Session
timeFrame: Enrollment through 56 days after participant's selected quit date (56 to 63 days total)
Secondary outcomes:
measure: Unique Days With at Least One App Session
timeFrame: Enrollment through 56 days after participant's selected quit date (56 to 63 days total)
measure: Self-reported 7-day Point-prevalence Abstinence at 2 Months
timeFrame: 56 days after participant's selected quit date (56 to 63 days after enrollment)
measure: Self-reported 30-day Point-prevalence Abstinence at 2 Months
timeFrame: 56 days after participant's selected quit date (56 to 63 days after enrollment)
measure: Satisfaction With App
timeFrame: 56 days after participant's selected quit date (56 to 63 days after enrollment)
measure: Satisfaction With Game (Intervention Group Only)
timeFrame: 56 days after participant's selected quit date (56 to 63 days after enrollment)
Other outcomes:
measure: Biochemically Verified 7-day Point-prevalence Abstinence at 2 Months
timeFrame: 56 days after participant's selected quit date (56 to 63 days after enrollment)
measure: Biochemically Verified 30-day Point-prevalence Abstinence at 2 Months
timeFrame: 56 days after participant's selected quit date (56 to 63 days after enrollment)
measure: Repeated 1-day Point-prevalence Smoking Abstinence
timeFrame: During the 56 days after participant's selected quit date
measure: Program Adherence (Index of Core Feature Use)
timeFrame: Enrollment through 56 days after participant's selected quit date (56 to 63 days total)
measure: Gifts Unlocked (Intervention Group Only)
timeFrame: Enrollment through 56 days after participant's selected quit date (56 to 63 days total)
measure: Game Activities (Intervention Group Only)
timeFrame: Enrollment through 56 days after participant's selected quit date (56 to 63 days total)
measure: Recommends App to Friend
timeFrame: 56 days after participant's selected quit date (56 to 63 days after enrollment)
measure: Motivation to Quit
timeFrame: 56 days after participant's selected quit date (56 to 63 days after enrollment)
measure: Digital Therapeutic Alliance
timeFrame: 56 days after participant's selected quit date (56 to 63 days after enrollment)
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Justin White, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: White JS, Salem MK, Toussaert S, Westmaas JL, Raiff BR, Crane D, Warrender E, Lyles C, Abroms L, Thrul J. Developing a Game (Inner Dragon) Within a Leading Smartphone App for Smoking Cessation: Design and Feasibility Evaluation Study. JMIR Serious Games. 2023 Aug 11;11:e46602. doi: 10.2196/46602.