Trial Outcomes & Findings for Pilot Trial of a Game Embedded in a Smartphone App for Smoking Cessation (NCT NCT05227027)
NCT ID: NCT05227027
Last Updated: 2024-01-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
500 participants
Primary outcome timeframe
Enrollment through 56 days after participant's selected quit date (56 to 63 days total)
Results posted on
2024-01-03
Participant Flow
Participant milestones
| Measure |
Educational Intervention Plus Game Module
Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application, as well as the integrated game module. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance.
Game module: Receive free access to the the Inner Dragon game module integrated into the Smoke Free smartphone application. In the Inner Dragon game, users care for a customizable pet dragon. that "evolves" in tandem with the user's progress in quitting smoking. The game includes several key features: 1) the dragon hatches on the user's quit day and evolves every 7 days to unlock new attributes and powers; 2) users earn experience points by using selected core app features; 3) users maintain "care meters" that change when the dragon is fed or pet; 4) the game provides tools for the user to better cope with the challenges of withdrawal, such as a breathing exercise to provide calmness and a memory minigame as a distraction; and 5) users can asynchronously interact with other users' dragons in a "dragon park."
|
Educational Intervention Only
Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application only. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance.
|
|---|---|---|
|
Overall Study
STARTED
|
251
|
249
|
|
Overall Study
COMPLETED
|
241
|
238
|
|
Overall Study
NOT COMPLETED
|
10
|
11
|
Reasons for withdrawal
| Measure |
Educational Intervention Plus Game Module
Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application, as well as the integrated game module. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance.
Game module: Receive free access to the the Inner Dragon game module integrated into the Smoke Free smartphone application. In the Inner Dragon game, users care for a customizable pet dragon. that "evolves" in tandem with the user's progress in quitting smoking. The game includes several key features: 1) the dragon hatches on the user's quit day and evolves every 7 days to unlock new attributes and powers; 2) users earn experience points by using selected core app features; 3) users maintain "care meters" that change when the dragon is fed or pet; 4) the game provides tools for the user to better cope with the challenges of withdrawal, such as a breathing exercise to provide calmness and a memory minigame as a distraction; and 5) users can asynchronously interact with other users' dragons in a "dragon park."
|
Educational Intervention Only
Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application only. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance.
|
|---|---|---|
|
Overall Study
Did not finish the onboarding process within the Smoke Free app prior to learning their allocation
|
10
|
11
|
Baseline Characteristics
Pilot Trial of a Game Embedded in a Smartphone App for Smoking Cessation
Baseline characteristics by cohort
| Measure |
Educational Intervention Plus Game Module
n=241 Participants
Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application, as well as the integrated game module. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance.
Game module: Receive free access to the the Inner Dragon game module integrated into the Smoke Free smartphone application. In the Inner Dragon game, users care for a customizable pet dragon. that "evolves" in tandem with the user's progress in quitting smoking. The game includes several key features: 1) the dragon hatches on the user's quit day and evolves every 7 days to unlock new attributes and powers; 2) users earn experience points by using selected core app features; 3) users maintain "care meters" that change when the dragon is fed or pet; 4) the game provides tools for the user to better cope with the challenges of withdrawal, such as a breathing exercise to provide calmness and a memory minigame as a distraction; and 5) users can asynchronously interact with other users' dragons in a "dragon park."
|
Educational Intervention Only
n=238 Participants
Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application only. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance.
|
Total
n=479 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38 years
n=5 Participants
|
35 years
n=7 Participants
|
36 years
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
177 Participants
n=5 Participants
|
181 Participants
n=7 Participants
|
358 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
59 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Non-binary or other
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race and ethnicity · Non-Hispanic White
|
186 Participants
n=5 Participants
|
182 Participants
n=7 Participants
|
368 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race and ethnicity · Non-Hispanic Black
|
22 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race and ethnicity · Hispanic
|
19 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race and ethnicity · Other
|
14 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Educational attainment
High school diploma or less
|
45 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Educational attainment
Some college or technical school
|
93 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
|
Educational attainment
Bachelor's or associate degree
|
83 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Educational attainment
Graduate degree
|
20 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Household income, categorical
Less than $20,000
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Household income, categorical
Between $20,000 and $40,000
|
63 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Household income, categorical
Between $40,000 and $60,000
|
51 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Household income, categorical
Between $60,000 and $80,000
|
32 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Household income, categorical
Between $80,000 and $100,000
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Household income, categorical
More than $100,000
|
39 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Cigarettes per day
|
15 cigarettes
n=5 Participants
|
15 cigarettes
n=7 Participants
|
15 cigarettes
n=5 Participants
|
|
Fagerström Test for Nicotine Dependence
|
5 units on a scale
n=5 Participants
|
5 units on a scale
n=7 Participants
|
5 units on a scale
n=5 Participants
|
|
Past quit attempts
|
4 attempts
n=5 Participants
|
4 attempts
n=7 Participants
|
4 attempts
n=5 Participants
|
|
Years since initiated smoking
|
19 years
n=5 Participants
|
16 years
n=7 Participants
|
18 years
n=5 Participants
|
|
Used electronic nicotine device systems in last 30 days
|
57 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Used nicotine replacmeent therapy in last 30 days
|
56 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Frequency played video games in last 6 months
Not at all
|
57 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Frequency played video games in last 6 months
Less than once a month
|
36 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Frequency played video games in last 6 months
At least monthly but not weekly
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Frequency played video games in last 6 months
At least weekly but not every day
|
49 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Frequency played video games in last 6 months
Every day
|
73 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
162 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Educational Intervention Plus Game Module
n=241 Participants
Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application, as well as the integrated game module. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance.
Game module: Receive free access to the the Inner Dragon game module integrated into the Smoke Free smartphone application. In the Inner Dragon game, users care for a customizable pet dragon. that "evolves" in tandem with the user's progress in quitting smoking. The game includes several key features: 1) the dragon hatches on the user's quit day and evolves every 7 days to unlock new attributes and powers; 2) users earn experience points by using selected core app features; 3) users maintain "care meters" that change when the dragon is fed or pet; 4) the game provides tools for the user to better cope with the challenges of withdrawal, such as a breathing exercise to provide calmness and a memory minigame as a distraction; and 5) users can asynchronously interact with other users' dragons in a "dragon park."
|
Educational Intervention Only
n=238 Participants
Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application only. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance.
|
|---|---|---|
|
Number of Unique App Sessions
|
29.6 number of sessions
Standard Deviation 36.5
|
24.3 number of sessions
Standard Deviation 37.9
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Educational Intervention Plus Game Module
n=241 Participants
Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application, as well as the integrated game module. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance.
Game module: Receive free access to the the Inner Dragon game module integrated into the Smoke Free smartphone application. In the Inner Dragon game, users care for a customizable pet dragon. that "evolves" in tandem with the user's progress in quitting smoking. The game includes several key features: 1) the dragon hatches on the user's quit day and evolves every 7 days to unlock new attributes and powers; 2) users earn experience points by using selected core app features; 3) users maintain "care meters" that change when the dragon is fed or pet; 4) the game provides tools for the user to better cope with the challenges of withdrawal, such as a breathing exercise to provide calmness and a memory minigame as a distraction; and 5) users can asynchronously interact with other users' dragons in a "dragon park."
|
Educational Intervention Only
n=238 Participants
Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application only. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance.
|
|---|---|---|
|
Minutes of App Usage Per Session
|
6.9 minutes per session
Standard Deviation 5.4
|
6.1 minutes per session
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Educational Intervention Plus Game Module
n=241 Participants
Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application, as well as the integrated game module. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance.
Game module: Receive free access to the the Inner Dragon game module integrated into the Smoke Free smartphone application. In the Inner Dragon game, users care for a customizable pet dragon. that "evolves" in tandem with the user's progress in quitting smoking. The game includes several key features: 1) the dragon hatches on the user's quit day and evolves every 7 days to unlock new attributes and powers; 2) users earn experience points by using selected core app features; 3) users maintain "care meters" that change when the dragon is fed or pet; 4) the game provides tools for the user to better cope with the challenges of withdrawal, such as a breathing exercise to provide calmness and a memory minigame as a distraction; and 5) users can asynchronously interact with other users' dragons in a "dragon park."
|
Educational Intervention Only
n=238 Participants
Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application only. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance.
|
|---|---|---|
|
Unique Days With at Least One App Session
|
14.3 days with a session
Standard Deviation 15.3
|
11.9 days with a session
Standard Deviation 13.3
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Educational Intervention Plus Game Module
n=241 Participants
Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application, as well as the integrated game module. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance.
Game module: Receive free access to the the Inner Dragon game module integrated into the Smoke Free smartphone application. In the Inner Dragon game, users care for a customizable pet dragon. that "evolves" in tandem with the user's progress in quitting smoking. The game includes several key features: 1) the dragon hatches on the user's quit day and evolves every 7 days to unlock new attributes and powers; 2) users earn experience points by using selected core app features; 3) users maintain "care meters" that change when the dragon is fed or pet; 4) the game provides tools for the user to better cope with the challenges of withdrawal, such as a breathing exercise to provide calmness and a memory minigame as a distraction; and 5) users can asynchronously interact with other users' dragons in a "dragon park."
|
Educational Intervention Only
n=238 Participants
Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application only. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance.
|
|---|---|---|
|
Self-reported 7-day Point-prevalence Abstinence at 2 Months
|
94 Participants
|
101 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Educational Intervention Plus Game Module
n=241 Participants
Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application, as well as the integrated game module. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance.
Game module: Receive free access to the the Inner Dragon game module integrated into the Smoke Free smartphone application. In the Inner Dragon game, users care for a customizable pet dragon. that "evolves" in tandem with the user's progress in quitting smoking. The game includes several key features: 1) the dragon hatches on the user's quit day and evolves every 7 days to unlock new attributes and powers; 2) users earn experience points by using selected core app features; 3) users maintain "care meters" that change when the dragon is fed or pet; 4) the game provides tools for the user to better cope with the challenges of withdrawal, such as a breathing exercise to provide calmness and a memory minigame as a distraction; and 5) users can asynchronously interact with other users' dragons in a "dragon park."
|
Educational Intervention Only
n=238 Participants
Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application only. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance.
|
|---|---|---|
|
Self-reported 30-day Point-prevalence Abstinence at 2 Months
|
54 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: 56 days after participant's selected quit date (56 to 63 days after enrollment)Population: Only those participants who completed the follow-up questionnaire are included in the analysis population.
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.
Outcome measures
| Measure |
Educational Intervention Plus Game Module
n=144 Participants
Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application, as well as the integrated game module. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance.
Game module: Receive free access to the the Inner Dragon game module integrated into the Smoke Free smartphone application. In the Inner Dragon game, users care for a customizable pet dragon. that "evolves" in tandem with the user's progress in quitting smoking. The game includes several key features: 1) the dragon hatches on the user's quit day and evolves every 7 days to unlock new attributes and powers; 2) users earn experience points by using selected core app features; 3) users maintain "care meters" that change when the dragon is fed or pet; 4) the game provides tools for the user to better cope with the challenges of withdrawal, such as a breathing exercise to provide calmness and a memory minigame as a distraction; and 5) users can asynchronously interact with other users' dragons in a "dragon park."
|
Educational Intervention Only
n=127 Participants
Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application only. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance.
|
|---|---|---|
|
Satisfaction With App
|
3.7 units on a scale
Standard Deviation 1.0
|
3.7 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 56 days after participant's selected quit date (56 to 63 days after enrollment)Population: Only those participants in the intervention group who completed the follow-up questionnaire are included in the analysis population.
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.
Outcome measures
| Measure |
Educational Intervention Plus Game Module
n=84 Participants
Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application, as well as the integrated game module. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance.
Game module: Receive free access to the the Inner Dragon game module integrated into the Smoke Free smartphone application. In the Inner Dragon game, users care for a customizable pet dragon. that "evolves" in tandem with the user's progress in quitting smoking. The game includes several key features: 1) the dragon hatches on the user's quit day and evolves every 7 days to unlock new attributes and powers; 2) users earn experience points by using selected core app features; 3) users maintain "care meters" that change when the dragon is fed or pet; 4) the game provides tools for the user to better cope with the challenges of withdrawal, such as a breathing exercise to provide calmness and a memory minigame as a distraction; and 5) users can asynchronously interact with other users' dragons in a "dragon park."
|
Educational Intervention Only
Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application only. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance.
|
|---|---|---|
|
Satisfaction With Game (Intervention Group Only)
|
3.3 units on a scale
Standard Deviation 1.4
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
| Measure |
Educational Intervention Plus Game Module
n=241 Participants
Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application, as well as the integrated game module. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance.
Game module: Receive free access to the the Inner Dragon game module integrated into the Smoke Free smartphone application. In the Inner Dragon game, users care for a customizable pet dragon. that "evolves" in tandem with the user's progress in quitting smoking. The game includes several key features: 1) the dragon hatches on the user's quit day and evolves every 7 days to unlock new attributes and powers; 2) users earn experience points by using selected core app features; 3) users maintain "care meters" that change when the dragon is fed or pet; 4) the game provides tools for the user to better cope with the challenges of withdrawal, such as a breathing exercise to provide calmness and a memory minigame as a distraction; and 5) users can asynchronously interact with other users' dragons in a "dragon park."
|
Educational Intervention Only
n=238 Participants
Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application only. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance.
|
|---|---|---|
|
Biochemically Verified 7-day Point-prevalence Abstinence at 2 Months
|
27 Participants
|
37 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
| Measure |
Educational Intervention Plus Game Module
n=241 Participants
Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application, as well as the integrated game module. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance.
Game module: Receive free access to the the Inner Dragon game module integrated into the Smoke Free smartphone application. In the Inner Dragon game, users care for a customizable pet dragon. that "evolves" in tandem with the user's progress in quitting smoking. The game includes several key features: 1) the dragon hatches on the user's quit day and evolves every 7 days to unlock new attributes and powers; 2) users earn experience points by using selected core app features; 3) users maintain "care meters" that change when the dragon is fed or pet; 4) the game provides tools for the user to better cope with the challenges of withdrawal, such as a breathing exercise to provide calmness and a memory minigame as a distraction; and 5) users can asynchronously interact with other users' dragons in a "dragon park."
|
Educational Intervention Only
n=238 Participants
Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application only. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance.
|
|---|---|---|
|
Biochemically Verified 30-day Point-prevalence Abstinence at 2 Months
|
19 Participants
|
31 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During the 56 days after participant's selected quit dateProportion 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.
Outcome measures
| Measure |
Educational Intervention Plus Game Module
n=241 Participants
Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application, as well as the integrated game module. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance.
Game module: Receive free access to the the Inner Dragon game module integrated into the Smoke Free smartphone application. In the Inner Dragon game, users care for a customizable pet dragon. that "evolves" in tandem with the user's progress in quitting smoking. The game includes several key features: 1) the dragon hatches on the user's quit day and evolves every 7 days to unlock new attributes and powers; 2) users earn experience points by using selected core app features; 3) users maintain "care meters" that change when the dragon is fed or pet; 4) the game provides tools for the user to better cope with the challenges of withdrawal, such as a breathing exercise to provide calmness and a memory minigame as a distraction; and 5) users can asynchronously interact with other users' dragons in a "dragon park."
|
Educational Intervention Only
n=238 Participants
Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application only. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance.
|
|---|---|---|
|
Repeated 1-day Point-prevalence Smoking Abstinence
|
17.3 percentage of days
Standard Deviation 25.6
|
12.4 percentage of days
Standard Deviation 21.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
| Measure |
Educational Intervention Plus Game Module
n=241 Participants
Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application, as well as the integrated game module. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance.
Game module: Receive free access to the the Inner Dragon game module integrated into the Smoke Free smartphone application. In the Inner Dragon game, users care for a customizable pet dragon. that "evolves" in tandem with the user's progress in quitting smoking. The game includes several key features: 1) the dragon hatches on the user's quit day and evolves every 7 days to unlock new attributes and powers; 2) users earn experience points by using selected core app features; 3) users maintain "care meters" that change when the dragon is fed or pet; 4) the game provides tools for the user to better cope with the challenges of withdrawal, such as a breathing exercise to provide calmness and a memory minigame as a distraction; and 5) users can asynchronously interact with other users' dragons in a "dragon park."
|
Educational Intervention Only
n=238 Participants
Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application only. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance.
|
|---|---|---|
|
Program Adherence (Index of Core Feature Use)
|
19.0 number of core features used
Standard Deviation 28.2
|
15.6 number of core features used
Standard Deviation 29.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Enrollment through 56 days after participant's selected quit date (56 to 63 days total)Population: In-game gifts available for 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.
Outcome measures
| Measure |
Educational Intervention Plus Game Module
n=241 Participants
Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application, as well as the integrated game module. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance.
Game module: Receive free access to the the Inner Dragon game module integrated into the Smoke Free smartphone application. In the Inner Dragon game, users care for a customizable pet dragon. that "evolves" in tandem with the user's progress in quitting smoking. The game includes several key features: 1) the dragon hatches on the user's quit day and evolves every 7 days to unlock new attributes and powers; 2) users earn experience points by using selected core app features; 3) users maintain "care meters" that change when the dragon is fed or pet; 4) the game provides tools for the user to better cope with the challenges of withdrawal, such as a breathing exercise to provide calmness and a memory minigame as a distraction; and 5) users can asynchronously interact with other users' dragons in a "dragon park."
|
Educational Intervention Only
Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application only. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance.
|
|---|---|---|
|
Gifts Unlocked (Intervention Group Only)
|
3.3 number of gifts unlocked
Standard Deviation 6.9
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Enrollment through 56 days after participant's selected quit date (56 to 63 days total)Population: Applicable to 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.
Outcome measures
| Measure |
Educational Intervention Plus Game Module
n=241 Participants
Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application, as well as the integrated game module. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance.
Game module: Receive free access to the the Inner Dragon game module integrated into the Smoke Free smartphone application. In the Inner Dragon game, users care for a customizable pet dragon. that "evolves" in tandem with the user's progress in quitting smoking. The game includes several key features: 1) the dragon hatches on the user's quit day and evolves every 7 days to unlock new attributes and powers; 2) users earn experience points by using selected core app features; 3) users maintain "care meters" that change when the dragon is fed or pet; 4) the game provides tools for the user to better cope with the challenges of withdrawal, such as a breathing exercise to provide calmness and a memory minigame as a distraction; and 5) users can asynchronously interact with other users' dragons in a "dragon park."
|
Educational Intervention Only
Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application only. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance.
|
|---|---|---|
|
Game Activities (Intervention Group Only)
|
123.1 number of game features used
Standard Deviation 285.0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 56 days after participant's selected quit date (56 to 63 days after enrollment)Population: Only those participants who completed the follow-up questionnaire are included in the analysis population.
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.
Outcome measures
| Measure |
Educational Intervention Plus Game Module
n=144 Participants
Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application, as well as the integrated game module. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance.
Game module: Receive free access to the the Inner Dragon game module integrated into the Smoke Free smartphone application. In the Inner Dragon game, users care for a customizable pet dragon. that "evolves" in tandem with the user's progress in quitting smoking. The game includes several key features: 1) the dragon hatches on the user's quit day and evolves every 7 days to unlock new attributes and powers; 2) users earn experience points by using selected core app features; 3) users maintain "care meters" that change when the dragon is fed or pet; 4) the game provides tools for the user to better cope with the challenges of withdrawal, such as a breathing exercise to provide calmness and a memory minigame as a distraction; and 5) users can asynchronously interact with other users' dragons in a "dragon park."
|
Educational Intervention Only
n=127 Participants
Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application only. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance.
|
|---|---|---|
|
Recommends App to Friend
|
3.8 units on a scale
Standard Deviation 1.1
|
4.0 units on a scale
Standard Deviation 1.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 56 days after participant's selected quit date (56 to 63 days after enrollment)Population: Only those participants who completed the question in the follow-up questionnaire are included in the analysis population. A programming error led to missing data for most respondents who reported having continued to smoke.
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.
Outcome measures
| Measure |
Educational Intervention Plus Game Module
n=73 Participants
Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application, as well as the integrated game module. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance.
Game module: Receive free access to the the Inner Dragon game module integrated into the Smoke Free smartphone application. In the Inner Dragon game, users care for a customizable pet dragon. that "evolves" in tandem with the user's progress in quitting smoking. The game includes several key features: 1) the dragon hatches on the user's quit day and evolves every 7 days to unlock new attributes and powers; 2) users earn experience points by using selected core app features; 3) users maintain "care meters" that change when the dragon is fed or pet; 4) the game provides tools for the user to better cope with the challenges of withdrawal, such as a breathing exercise to provide calmness and a memory minigame as a distraction; and 5) users can asynchronously interact with other users' dragons in a "dragon park."
|
Educational Intervention Only
n=71 Participants
Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application only. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance.
|
|---|---|---|
|
Motivation to Quit
|
9.3 units on a scale
Standard Deviation 1.3
|
9.4 units on a scale
Standard Deviation 1.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 56 days after participant's selected quit date (56 to 63 days after enrollment)Population: Only those participants who completed the questions in the follow-up questionnaire are included in the analysis population.
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.
Outcome measures
| Measure |
Educational Intervention Plus Game Module
n=150 Participants
Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application, as well as the integrated game module. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance.
Game module: Receive free access to the the Inner Dragon game module integrated into the Smoke Free smartphone application. In the Inner Dragon game, users care for a customizable pet dragon. that "evolves" in tandem with the user's progress in quitting smoking. The game includes several key features: 1) the dragon hatches on the user's quit day and evolves every 7 days to unlock new attributes and powers; 2) users earn experience points by using selected core app features; 3) users maintain "care meters" that change when the dragon is fed or pet; 4) the game provides tools for the user to better cope with the challenges of withdrawal, such as a breathing exercise to provide calmness and a memory minigame as a distraction; and 5) users can asynchronously interact with other users' dragons in a "dragon park."
|
Educational Intervention Only
n=129 Participants
Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application only. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance.
|
|---|---|---|
|
Digital Therapeutic Alliance
|
12.7 units on a scale
Standard Deviation 2.2
|
12.8 units on a scale
Standard Deviation 2.5
|
Adverse Events
Educational Intervention Plus Game Module
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Educational Intervention Only
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Educational Intervention Plus Game Module
n=241 participants at risk
Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application, as well as the integrated game module. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance.
Game module: Receive free access to the the Inner Dragon game module integrated into the Smoke Free smartphone application. In the Inner Dragon game, users care for a customizable pet dragon. that "evolves" in tandem with the user's progress in quitting smoking. The game includes several key features: 1) the dragon hatches on the user's quit day and evolves every 7 days to unlock new attributes and powers; 2) users earn experience points by using selected core app features; 3) users maintain "care meters" that change when the dragon is fed or pet; 4) the game provides tools for the user to better cope with the challenges of withdrawal, such as a breathing exercise to provide calmness and a memory minigame as a distraction; and 5) users can asynchronously interact with other users' dragons in a "dragon park."
|
Educational Intervention Only
n=239 participants at risk；n=238 participants at risk
Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application only. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance.
|
|---|---|---|
|
Psychiatric disorders
Anxious or depressed
|
0.41%
1/241 • 63 days after enrollment
Adverse events were reported based on survey responses to "Did you experience any negative, unpleasant, unwanted, or otherwise unexpected side effects as a result of participating in this trial?"
|
1.3%
3/239 • 63 days after enrollment
Adverse events were reported based on survey responses to "Did you experience any negative, unpleasant, unwanted, or otherwise unexpected side effects as a result of participating in this trial?"
|
|
Psychiatric disorders
Feelings of withdrawal, craving, or irritability
|
0.41%
1/241 • 63 days after enrollment
Adverse events were reported based on survey responses to "Did you experience any negative, unpleasant, unwanted, or otherwise unexpected side effects as a result of participating in this trial?"
|
1.7%
4/239 • 63 days after enrollment
Adverse events were reported based on survey responses to "Did you experience any negative, unpleasant, unwanted, or otherwise unexpected side effects as a result of participating in this trial?"
|
|
Gastrointestinal disorders
Constipation
|
0.41%
1/241 • 63 days after enrollment
Adverse events were reported based on survey responses to "Did you experience any negative, unpleasant, unwanted, or otherwise unexpected side effects as a result of participating in this trial?"
|
0.00%
0/239 • 63 days after enrollment
Adverse events were reported based on survey responses to "Did you experience any negative, unpleasant, unwanted, or otherwise unexpected side effects as a result of participating in this trial?"
|
Additional Information
Dr. Justin White, Associate Professor
University of California, San Francisco
Phone: 415-476-8045
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place