Pilot Trial of a Game Embedded in a Smartphone App for Smoking Cessation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cigarette Smoking-Related Carcinoma

Intervention / Treatment
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* Behavioral: Game Module
* Behavioral: Smoke Free smartphone application


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Provides electronic informed consent. Male or female, aged 18 and older Has downloaded and opened the Smoke Free app A smoker of at least 1 cigarette per day Plans to quit smoking within the next 7 days Speaks, reads, and writes English Lives in the United States Exclusion criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Education plus game module<br>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<br>* Receive access to the the game module through the free, 'Smoke Free' smartphone application<br>* Other names: In-application game module;Behavioral: Smoke Free smartphone application<br>* Receive educational intervention through the free 'Smoke Free' smartphone application (core version of the app)<br>* Other names: Educational intervention;|
| Active Comparator: Education module only<br>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<br>* Receive educational intervention through the free 'Smoke Free' smartphone application (core version of the app)<br>* Other names: Educational intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of unique app sessions | 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. | Enrollment through 56 days after participant's selected quit date (56 to 63 days total) | 
| Minutes of app usage per session | 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. | Enrollment through 56 days after participant's selected quit date (56 to 63 days total) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unique days with at least one app session | Number of unique days with at least one app session, passively collected by the app and averaged by study group. | 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 | Proportion of participants who who self-report having abstained for the prior 7 days during the 2-month follow-up assessment. | 56 days after participant's selected quit date (56 to 63 days after enrollment) | 
| Self-reported 30-day point-prevalence abstinence at 2 months | Proportion of participants who who self-report having abstained for the prior 30 days during the 2-month follow-up assessment. | 56 days after participant's selected quit date (56 to 63 days after enrollment) | 
| Satisfaction with app | 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. | 56 days after participant's selected quit date (56 to 63 days after enrollment) | 
| Satisfaction with game (intervention group only) | 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. | 56 days after participant's selected quit date (56 to 63 days after enrollment) |