Pilot Trial of a Game Embedded in a Smartphone App for Smoking Cessation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
PRIMARY OBJECTIVES:
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Augment an existing smartphone cessation app for smoking cessation with a video game to increase user engagement.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Education plus game module 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. |
Behavioral: Game Module
Receive access to the the game module through the free, 'Smoke Free' smartphone application
Other Names:
Behavioral: Smoke Free smartphone application
Receive educational intervention through the free 'Smoke Free' smartphone application (core version of the app)
Other Names:
|
| Active Comparator: Education module only 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. |
Behavioral: Smoke Free smartphone application
Receive educational intervention through the free 'Smoke Free' smartphone application (core version of the app)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of unique app sessions [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 [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.
Secondary Outcome Measures
- Unique days with at least one app session [Enrollment through 56 days after participant's selected quit date (56 to 63 days total)]
Number of unique days with at least one app session, passively collected by the app and averaged by study group.
- Self-reported 7-day point-prevalence abstinence at 2 months [56 days after participant's selected quit date (56 to 63 days after enrollment)]
Proportion of participants who who self-report having abstained for the prior 7 days during the 2-month follow-up assessment.
- Self-reported 30-day point-prevalence abstinence at 2 months [56 days after participant's selected quit date (56 to 63 days after enrollment)]
Proportion of participants who who self-report having abstained for the prior 30 days during the 2-month follow-up assessment.
- Satisfaction with app [56 days after participant's selected quit date (56 to 63 days after enrollment)]
Rating of satisfaction with assigned app on a 5-point Likert scale from "Not at all" (1) to "Extremely" (5), assessed in the 2-month follow-up questionnaire. The measure is dichotomized at a threshold of "Somewhat" (3) or higher. Averaged by study group.
- Satisfaction with game (intervention group only) [56 days after participant's selected quit date (56 to 63 days after enrollment)]
Rating of satisfaction with the game on a 5-point Likert scale from "Not at all" (1) to "Extremely" (5), assessed in the 2-month follow-up questionnaire. The measure is dichotomized at a threshold of "Somewhat" (3) or higher. Averaged for the intervention group.
Other Outcome Measures
- Biochemically verified 7-day point-prevalence abstinence at 2 months [56 days after participant's selected quit date (56 to 63 days after enrollment)]
Proportion of participants who who self-report having abstained for the prior 7 days during the 2-month follow-up assessment, verified by saliva cotinine test. Averaged by study group. Recoded to 0 if the person reported having smoked during the same 7-day window during repeated measurement of daily smoking in the app.
- Biochemically verified 30-day point-prevalence abstinence at 2 months [56 days after participant's selected quit date (56 to 63 days after enrollment)]
Proportion of participants who who self-report having abstained for the prior 30 days during the 2-month follow-up assessment, verified by saliva cotinine test. Averaged by study group. Recoded to 0 if the person reported having smoked during the same 30-day window during repeated measurement of daily smoking in the app.
- Repeated 1-day point-prevalence smoking abstinence [During the 56 days after participant's selected quit date]
Proportion of participants who self-report having abstained in the last 24 hours, collected via a pop-up box that appears the first time each day a participant opens the app. Averaged by study group.
- Program adherence [Enrollment through 56 days after participant's selected quit date (56 to 63 days total)]
Number of non-game (core app) activities completed in the app by activity type: passively collected by the app to assess number of times the participant completed the following activity types: reported a craving, recorded a diary, completed a mission, read a tip, used the chatbot.
- Gifts unlocked (intervention group only) [Enrollment through 56 days after participant's selected quit date (56 to 63 days total)]
Number of in-game gifts unlocked during the study period (intervention group only); a summary measure of intensity of engagement (dose of treatment) of the app; passively collected by the app.
- Game activities (intervention group only) [Enrollment through 56 days after participant's selected quit date (56 to 63 days total)]
Number of game activities completed in the app by activity type; passively collected by the app to assess number of times the participant completed the following activity types: navigated to the game dashboard, completed each pet care activity (breathing exercise, feeding, washing, mini-game), visited the park, sent a message to another user in the park, used the customization menu to change appearance.
- Recommends app to friend [56 days after participant's selected quit date (56 to 63 days after enrollment)]
Rating of whether would recommend assigned app to a friend on a 5-point Likert scale from "Not at all" (1) to "Extremely" (5), assessed in the 2-month follow-up questionnaire. The measure is dichotomized at a threshold of "Somewhat" (3) or higher. Averaged by study group.
- Motivation to quit [56 days after participant's selected quit date (56 to 63 days after enrollment)]
Motivation to quit, reported on a 10-point scale from not at all motivated (0) to very unmotivated (10) and assessed in the 2-month follow-up.
- Digital therapeutic alliance [56 days after participant's selected quit date (56 to 63 days after enrollment)]
Bonding and confidence sub-scales of a digital therapeutic alliance scale, with each question reported on a 4-point scale. The measure is dichotomized at a threshold of "Agree" (3) or higher. Assessed in the 2-month follow-up.
Eligibility Criteria
Criteria
Inclusion criteria:
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Provides electronic informed consent.
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Male or female, aged 18 and older
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Has downloaded and opened the Smoke Free app
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A smoker of at least 1 cigarette per day
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Plans to quit smoking within the next 7 days
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Speaks, reads, and writes English
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Lives in the United States
Exclusion criteria: None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California San Francisco | San Francisco | California | United States | 94143 |
Sponsors and Collaborators
- University of California, San Francisco
- National Cancer Institute (NCI)
- National Institute on Aging (NIA)
- University of California, Berkeley
- Johns Hopkins University
Investigators
- Principal Investigator: Justin White, PhD, University of California, San Francisco
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19-29335
- NCI-2021-07004
- P30AG012839
- R21CA238301