Trial Outcomes & Findings for QuitGuide for American Indians: Aims 2 & 3 (NCT NCT05447156)
NCT ID: NCT05447156
Last Updated: 2025-04-11
Results Overview
The number of times the app is initiated per day will be measured using data from Smokefree.gov. If a participant does not use the app on a particular day, Smokefree.gov records this as non-use or 0 for that day. The total number of times will be summarized for analysis by totaling the number of times the app is initiated from randomization to 5 weeks post-randomization.
COMPLETED
NA
115 participants
5 weeks post enrollment and 1 week post randomization
2025-04-11
Participant Flow
Participant milestones
| Measure |
Aim 3:Tailored App
Randomized subset of participants will use the tailored QuitGuide app, a smoking cessation app, downloaded to their personal phone.
Tailored QuitGuide app: This is an app not available to the public. It was developed/tailored based on an app available to the public and can be downloaded.
|
Aim 3: Standard App
Randomized subset of participants will use the standard QuitGuide app, a smoking cessation app available to the public, downloaded to their personal phone.
Standard QuitGuide app: This is an app available to the public.
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
57
|
|
Overall Study
COMPLETED
|
55
|
53
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sex not reported for one participant.
Baseline characteristics by cohort
| Measure |
Aim 3:Tailored App
n=58 Participants
Randomized subset of participants will use the tailored QuitGuide app, a smoking cessation app, downloaded to their personal phone.
Tailored QuitGuide app: This is an app not available to the public. It was developed/tailored based on an app available to the public and can be downloaded.
|
Aim 3: Standard App
n=57 Participants
Randomized subset of participants will use the standard QuitGuide app, a smoking cessation app available to the public, downloaded to their personal phone.
Standard QuitGuide app: This is an app available to the public.
|
Total
n=115 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
White
|
0 Participants
n=58 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=58 Participants
|
6 Participants
n=57 Participants
|
12 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=58 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
58 participants
n=58 Participants
|
57 participants
n=57 Participants
|
115 participants
n=115 Participants
|
|
Age, Customized
<=18 years
|
0 Participants
n=58 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=115 Participants
|
|
Age, Customized
>18 years
|
58 Participants
n=58 Participants
|
57 Participants
n=57 Participants
|
115 Participants
n=115 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=57 Participants • Sex not reported for one participant.
|
42 Participants
n=57 Participants • Sex not reported for one participant.
|
88 Participants
n=114 Participants • Sex not reported for one participant.
|
|
Sex: Female, Male
Male
|
11 Participants
n=57 Participants • Sex not reported for one participant.
|
15 Participants
n=57 Participants • Sex not reported for one participant.
|
26 Participants
n=114 Participants • Sex not reported for one participant.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=58 Participants
|
2 Participants
n=57 Participants
|
3 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
56 Participants
n=58 Participants
|
55 Participants
n=57 Participants
|
111 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=58 Participants
|
0 Participants
n=57 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
52 Participants
n=58 Participants
|
51 Participants
n=57 Participants
|
103 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=58 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=58 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=58 Participants
|
0 Participants
n=57 Participants
|
0 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 5 weeks post enrollment and 1 week post randomizationThe number of times the app is initiated per day will be measured using data from Smokefree.gov. If a participant does not use the app on a particular day, Smokefree.gov records this as non-use or 0 for that day. The total number of times will be summarized for analysis by totaling the number of times the app is initiated from randomization to 5 weeks post-randomization.
Outcome measures
| Measure |
Aim 3:Tailored App
n=58 Participants
Randomized subset of participants will use the tailored QuitGuide app, a smoking cessation app, downloaded to their personal phone.
Tailored QuitGuide app: This is an app not available to the public. It was developed/tailored based on an app available to the public and can be downloaded.
|
Aim 3: Standard App
n=57 Participants
Randomized subset of participants will use the standard QuitGuide app, a smoking cessation app available to the public, downloaded to their personal phone.
Standard QuitGuide app: This is an app available to the public.
|
|---|---|---|
|
Frequency of App Use
5 weeks post enrollment
|
15.3 App initiations per day
Standard Deviation 15.5
|
14.9 App initiations per day
Standard Deviation 17.8
|
|
Frequency of App Use
1 week post randomization
|
4.3 App initiations per day
Standard Deviation 5.1
|
3.7 App initiations per day
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: 5 weeks post enrollment aim 3Percentage of randomized participants that complete the final phone interview at 5 weeks
Outcome measures
| Measure |
Aim 3:Tailored App
n=58 Participants
Randomized subset of participants will use the tailored QuitGuide app, a smoking cessation app, downloaded to their personal phone.
Tailored QuitGuide app: This is an app not available to the public. It was developed/tailored based on an app available to the public and can be downloaded.
|
Aim 3: Standard App
n=57 Participants
Randomized subset of participants will use the standard QuitGuide app, a smoking cessation app available to the public, downloaded to their personal phone.
Standard QuitGuide app: This is an app available to the public.
|
|---|---|---|
|
Study Attrition Measured as Percentage of Randomized Participants That Complete the Final Phone Interview at 5 Weeks
|
55 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: 5 weeks post enrollment aim 3Count of randomized participants that return saliva sample 2 weeks after the 5 weeks post enrollment (end of intervention)
Outcome measures
| Measure |
Aim 3:Tailored App
n=58 Participants
Randomized subset of participants will use the tailored QuitGuide app, a smoking cessation app, downloaded to their personal phone.
Tailored QuitGuide app: This is an app not available to the public. It was developed/tailored based on an app available to the public and can be downloaded.
|
Aim 3: Standard App
n=57 Participants
Randomized subset of participants will use the standard QuitGuide app, a smoking cessation app available to the public, downloaded to their personal phone.
Standard QuitGuide app: This is an app available to the public.
|
|---|---|---|
|
Frequency of Returning Saliva Sample by 2 Weeks Post the Week 5 Interview
|
35 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: 5 weeks post enrollmentScores for each question (1-5) are added together for an overall score of 100. 100 means the website is rated at optimal usability. Scores lower than 100 indicate the website needs improvements. Mean and standard deviations or medians and ranges of percentile rankings will be calculated. Minimum score of zero.
Outcome measures
| Measure |
Aim 3:Tailored App
n=55 Participants
Randomized subset of participants will use the tailored QuitGuide app, a smoking cessation app, downloaded to their personal phone.
Tailored QuitGuide app: This is an app not available to the public. It was developed/tailored based on an app available to the public and can be downloaded.
|
Aim 3: Standard App
n=53 Participants
Randomized subset of participants will use the standard QuitGuide app, a smoking cessation app available to the public, downloaded to their personal phone.
Standard QuitGuide app: This is an app available to the public.
|
|---|---|---|
|
Usability of App Design Measured Using System Usability Scale (SUS)
|
72.4 score on a scale
Standard Deviation 15.6
|
71.9 score on a scale
Standard Deviation 13.3
|
SECONDARY outcome
Timeframe: 5 weeks post enrollmentMean and standard deviations or medians and ranges of Likert-scale responses to questions such as 'How likely would you be to recommend the app to a friend?'. Rated out of 7 points. 7 is the highest score, indicating participants are very likely to recommend the app to a friend. Scores lower than 7 indicate participants are less likely to recommend the app. Minimum score of zero.
Outcome measures
| Measure |
Aim 3:Tailored App
n=55 Participants
Randomized subset of participants will use the tailored QuitGuide app, a smoking cessation app, downloaded to their personal phone.
Tailored QuitGuide app: This is an app not available to the public. It was developed/tailored based on an app available to the public and can be downloaded.
|
Aim 3: Standard App
n=53 Participants
Randomized subset of participants will use the standard QuitGuide app, a smoking cessation app available to the public, downloaded to their personal phone.
Standard QuitGuide app: This is an app available to the public.
|
|---|---|---|
|
Acceptability of Overall App
|
5.6 units on a scale
Standard Deviation 1.6
|
4.9 units on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: 5 weeks post enrollmentMean and standard deviations or medians and ranges of Likert-scale responses to questions such as 'The app fits my American Indian culture such as its history, traditions, and customs'. Rated out of 7 points. 7 is the highest score, indicating participants feel app fits the American Indian culture. Scores lower than 7 indicate participants don't feel as strongly that app fits American Indian culture. Minimum score of zero.
Outcome measures
| Measure |
Aim 3:Tailored App
n=55 Participants
Randomized subset of participants will use the tailored QuitGuide app, a smoking cessation app, downloaded to their personal phone.
Tailored QuitGuide app: This is an app not available to the public. It was developed/tailored based on an app available to the public and can be downloaded.
|
Aim 3: Standard App
n=53 Participants
Randomized subset of participants will use the standard QuitGuide app, a smoking cessation app available to the public, downloaded to their personal phone.
Standard QuitGuide app: This is an app available to the public.
|
|---|---|---|
|
Fit of App With Culture
|
3.9 units on a scale
Standard Deviation 0.9
|
3.1 units on a scale
Standard Deviation 1.1
|
Adverse Events
Aim 3:Tailored App
Aim 3: Standard App
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dana Mowls Carroll, Ph.D., M.P.H.
Masonic Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place