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

Cigarette Smoking-Related Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05227027
• Other study ID #: 19-29335
• Secondary ID: NCI-2021-07004P3
• Status: Completed
• Phase: N/A
• Start date: February 9, 2022
• Est. completion date: May 31, 2022

Study information

• Verified date: November 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cigarette Smoking-Related Carcinoma

Intervention

Behavioral:
• Game Module
Receive access to the the game module through the free, 'Smoke Free' smartphone application
• Smoke Free smartphone application
Receive educational intervention through the free 'Smoke Free' smartphone application (core version of the app)

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (5)

Lead Sponsor	Collaborator
University of California, San Francisco	Johns Hopkins University, National Cancer Institute (NCI), National Institute on Aging (NIA), University of California, Berkeley

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Biochemically Verified 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, verified by saliva cotinine test, assuming missing = smoking. 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.	56 days after participant's selected quit date (56 to 63 days after enrollment)
Other	Biochemically Verified 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, verified by saliva cotinine test, assuming missing = smoking. 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.	56 days after participant's selected quit date (56 to 63 days after enrollment)
Other	Repeated 1-day Point-prevalence Smoking Abstinence	Proportion of days in which participants 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.	During the 56 days after participant's selected quit date
Other	Program Adherence (Index of Core Feature Use)	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.	Enrollment through 56 days after participant's selected quit date (56 to 63 days total)
Other	Gifts Unlocked (Intervention Group Only)	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.	Enrollment through 56 days after participant's selected quit date (56 to 63 days total)
Other	Game Activities (Intervention Group Only)	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, memory mini-game), visited the park, entered the dragon guide.	Enrollment through 56 days after participant's selected quit date (56 to 63 days total)
Other	Recommends App to Friend	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 averaged by study group.	56 days after participant's selected quit date (56 to 63 days after enrollment)
Other	Motivation to Quit	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.	56 days after participant's selected quit date (56 to 63 days after enrollment)
Other	Digital Therapeutic Alliance	The measure includes items from the Bonding and Confidence subscales from the Mobile Agnew Relationship Measure, a scale of digital therapeutic alliance. Two items from each of the Bonding and Confidence subscales were included. Each item was asked on a 4-point Likert scale from strongly disagree (1) to strongly agree (4). The subscale items were combined to give a total possible score of 16 and a range of 4 (low alliance) to 16 (high alliance). The measure is averaged by study group. Assessed in the 2-month follow-up.	56 days after participant's selected quit date (56 to 63 days after enrollment)
Primary	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)
Primary	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	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)
Secondary	Self-reported 7-day Point-prevalence Abstinence at 2 Months	Proportion of participants who self-report having abstained for the prior 7 days during the 2-month follow-up assessment, assuming missing = smoking.	56 days after participant's selected quit date (56 to 63 days after enrollment)
Secondary	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, assuming missing = smoking.	56 days after participant's selected quit date (56 to 63 days after enrollment)
Secondary	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 averaged by study group.	56 days after participant's selected quit date (56 to 63 days after enrollment)
Secondary	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 averaged for the intervention group.	56 days after participant's selected quit date (56 to 63 days after enrollment)