Tobacco Use, Tobacco Use Disorder
Conditions
Brief summary
Aim 3: To test feasibility, acceptability, and preliminary efficacy of the tailored QuitGuide for smoking cessation among AIs.
Interventions
BEHAVIORALTailored 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.
BEHAVIORALStandard QuitGuide app
This is an app available to the public.
Sponsors
Masonic Cancer Center, University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Aim 3: Participants will be randomized to either the tailored QuitGuide app or the standard version of the QuitGuide app for 5 weeks.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* American Indian person based on self-report * Age ≥ 18 years * Interested in quitting smoking * Smoke ≥ 3 commercial tobacco cigarette per day (CPD) in the past 30 days o Use of other commercial tobacco products (e.g., e-cigarettes) is permitted if they report cigarettes being their primary product * Smartphone ownership with the ability to download applications and sufficient data to complete research procedures
Exclusion criteria
* New or change in pharmacotherapy for smoking cessation (includes: nicotine gum, patch, lozenge, inhaler OR medications Chantix/Wellbtrutin/Zyban/Bupropion) in past month * Does not speak or read English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of App Use | 5 weeks post enrollment and 1 week post randomization | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Study Attrition Measured as Percentage of Randomized Participants That Complete the Final Phone Interview at 5 Weeks | 5 weeks post enrollment aim 3 | Percentage of randomized participants that complete the final phone interview at 5 weeks |
| Frequency of Returning Saliva Sample by 2 Weeks Post the Week 5 Interview | 5 weeks post enrollment aim 3 | Count of randomized participants that return saliva sample 2 weeks after the 5 weeks post enrollment (end of intervention) |
| Usability of App Design Measured Using System Usability Scale (SUS) | 5 weeks post enrollment | Scores 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. |
| Acceptability of Overall App | 5 weeks post enrollment | Mean 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. |
| Fit of App With Culture | 5 weeks post enrollment | Mean 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 58 |
| 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. | 57 |
| Total | 115 |
Baseline characteristics
| Characteristic | Aim 3:Tailored App | Aim 3: Standard App | Total |
|---|---|---|---|
| Age, Customized <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized >18 years | 58 Participants | 57 Participants | 115 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 56 Participants | 55 Participants | 111 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 52 Participants | 51 Participants | 103 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 6 Participants | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 58 participants | 57 participants | 115 participants |
| Sex: Female, Male Female | 46 Participants | 42 Participants | 88 Participants |
| Sex: Female, Male Male | 11 Participants | 15 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 58 | 0 / 57 |
| other Total, other adverse events | 0 / 58 | 0 / 57 |
| serious Total, serious adverse events | 0 / 58 | 0 / 57 |
Outcome results
Primary
Frequency of App Use
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.
Time frame: 5 weeks post enrollment and 1 week post randomization
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aim 3:Tailored App | Frequency of App Use | 5 weeks post enrollment | 15.3 App initiations per day | Standard Deviation 15.5 |
| Aim 3:Tailored App | Frequency of App Use | 1 week post randomization | 4.3 App initiations per day | Standard Deviation 5.1 |
| Aim 3: Standard App | Frequency of App Use | 5 weeks post enrollment | 14.9 App initiations per day | Standard Deviation 17.8 |
| Aim 3: Standard App | Frequency of App Use | 1 week post randomization | 3.7 App initiations per day | Standard Deviation 3.6 |
Secondary
Acceptability of Overall App
Mean 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.
Time frame: 5 weeks post enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aim 3:Tailored App | Acceptability of Overall App | 5.6 units on a scale | Standard Deviation 1.6 |
| Aim 3: Standard App | Acceptability of Overall App | 4.9 units on a scale | Standard Deviation 1.6 |
Secondary
Fit of App With Culture
Mean 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.
Time frame: 5 weeks post enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aim 3:Tailored App | Fit of App With Culture | 3.9 units on a scale | Standard Deviation 0.9 |
| Aim 3: Standard App | Fit of App With Culture | 3.1 units on a scale | Standard Deviation 1.1 |
Secondary
Frequency of Returning Saliva Sample by 2 Weeks Post the Week 5 Interview
Count of randomized participants that return saliva sample 2 weeks after the 5 weeks post enrollment (end of intervention)
Time frame: 5 weeks post enrollment aim 3
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aim 3:Tailored App | Frequency of Returning Saliva Sample by 2 Weeks Post the Week 5 Interview | 35 Participants |
| Aim 3: Standard App | Frequency of Returning Saliva Sample by 2 Weeks Post the Week 5 Interview | 31 Participants |
Secondary
Study Attrition Measured as Percentage of Randomized Participants That Complete the Final Phone Interview at 5 Weeks
Percentage of randomized participants that complete the final phone interview at 5 weeks
Time frame: 5 weeks post enrollment aim 3
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aim 3:Tailored App | Study Attrition Measured as Percentage of Randomized Participants That Complete the Final Phone Interview at 5 Weeks | 55 Participants |
| Aim 3: Standard App | Study Attrition Measured as Percentage of Randomized Participants That Complete the Final Phone Interview at 5 Weeks | 53 Participants |
Secondary
Usability of App Design Measured Using System Usability Scale (SUS)
Scores 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.
Time frame: 5 weeks post enrollment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aim 3:Tailored App | Usability of App Design Measured Using System Usability Scale (SUS) | 72.4 score on a scale | Standard Deviation 15.6 |
| Aim 3: Standard App | Usability of App Design Measured Using System Usability Scale (SUS) | 71.9 score on a scale | Standard Deviation 13.3 |