- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05227027
Pilot Trial of a Game Embedded in a Smartphone App for Smoking Cessation
Influence of a Game Embedded in a Smartphone App for Smoking Cessation on User Engagement: A Randomized Pilot Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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California
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San Francisco, California, United States, 94143
- University of California San Francisco
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
Receive access to the the game module through the free, 'Smoke Free' smartphone application
Other Names:
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.
|
Receive educational intervention through the free 'Smoke Free' smartphone application (core version of the app)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Unique App Sessions
Time Frame: 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.
|
Enrollment through 56 days after participant's selected quit date (56 to 63 days total)
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Minutes of App Usage Per Session
Time Frame: Enrollment through 56 days after participant's selected quit date (56 to 63 days total)
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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.
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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
Time Frame: Enrollment through 56 days after participant's selected quit date (56 to 63 days total)
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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
Time Frame: 56 days after participant's selected quit date (56 to 63 days after enrollment)
|
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)
|
Self-reported 30-day Point-prevalence Abstinence at 2 Months
Time Frame: 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, assuming missing = smoking.
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56 days after participant's selected quit date (56 to 63 days after enrollment)
|
Satisfaction With App
Time Frame: 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 averaged by study group.
|
56 days after participant's selected quit date (56 to 63 days after enrollment)
|
Satisfaction With Game (Intervention Group Only)
Time Frame: 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 averaged for the intervention group.
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56 days after participant's selected quit date (56 to 63 days after enrollment)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biochemically Verified 7-day Point-prevalence Abstinence at 2 Months
Time Frame: 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, 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.
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56 days after participant's selected quit date (56 to 63 days after enrollment)
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Biochemically Verified 30-day Point-prevalence Abstinence at 2 Months
Time Frame: 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, 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.
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56 days after participant's selected quit date (56 to 63 days after enrollment)
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Repeated 1-day Point-prevalence Smoking Abstinence
Time Frame: During the 56 days after participant's selected quit date
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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.
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During the 56 days after participant's selected quit date
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Program Adherence (Index of Core Feature Use)
Time Frame: Enrollment through 56 days after participant's selected quit date (56 to 63 days total)
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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.
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Enrollment through 56 days after participant's selected quit date (56 to 63 days total)
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Gifts Unlocked (Intervention Group Only)
Time Frame: Enrollment through 56 days after participant's selected quit date (56 to 63 days total)
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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.
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Enrollment through 56 days after participant's selected quit date (56 to 63 days total)
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Game Activities (Intervention Group Only)
Time Frame: Enrollment through 56 days after participant's selected quit date (56 to 63 days total)
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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.
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Enrollment through 56 days after participant's selected quit date (56 to 63 days total)
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Recommends App to Friend
Time Frame: 56 days after participant's selected quit date (56 to 63 days after enrollment)
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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.
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56 days after participant's selected quit date (56 to 63 days after enrollment)
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Motivation to Quit
Time Frame: 56 days after participant's selected quit date (56 to 63 days after enrollment)
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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.
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56 days after participant's selected quit date (56 to 63 days after enrollment)
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Digital Therapeutic Alliance
Time Frame: 56 days after participant's selected quit date (56 to 63 days after enrollment)
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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.
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56 days after participant's selected quit date (56 to 63 days after enrollment)
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Justin White, PhD, University of California, San Francisco
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 19-29335
- NCI-2021-07004 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- P30AG012839 (U.S. NIH Grant/Contract)
- R21CA238301 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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