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| ID | Type | Description | Link |
|---|---|---|---|
| MCC CPRC | Other Identifier | 2022LS018 |
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Aim 3: To test feasibility, acceptability, and preliminary efficacy of the tailored QuitGuide for smoking cessation among AIs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aim 3:Tailored App | Experimental | Randomized subset of participants will use the tailored QuitGuide app, a smoking cessation app, downloaded to their personal phone. |
|
| Aim 3: Standard App | Placebo Comparator | Randomized subset of participants will use the standard QuitGuide app, a smoking cessation app available to the public, downloaded to their personal phone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tailored QuitGuide app | Behavioral | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 weeks post enrollment and 1 week post randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 5 weeks post enrollment aim 3 |
| Frequency of Returning Saliva Sample by 2 Weeks Post the Week 5 Interview |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Dana Caroll, PhD | Masonic Cancer Center, Univeristy of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masonic Cancer Center - University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | App initiations per day | 5 weeks post enrollment and 1 week post randomization |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dana Mowls Carroll, Ph.D., M.P.H. | Masonic Cancer Center | 612-624-4511 | dcarroll@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 16, 2022 | Dec 4, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 23, 2022 | Feb 23, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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Aim 3: Participants will be randomized to either the tailored QuitGuide app or the standard version of the QuitGuide app for 5 weeks.
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| Standard QuitGuide app | Behavioral | This is an app available to the public. |
|
Count of randomized participants that return saliva sample 2 weeks after the 5 weeks post enrollment (end of intervention) |
| 5 weeks post enrollment aim 3 |
| 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. | 5 weeks post enrollment |
| 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. | 5 weeks post enrollment |
| 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. | 5 weeks post enrollment |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Sex not reported for one participant. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| 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. |
|
|
| 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 | Posted | Count of Participants | Participants | 5 weeks post enrollment aim 3 |
|
|
|
| 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) | Posted | Count of Participants | Participants | 5 weeks post enrollment aim 3 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 5 weeks post enrollment |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 5 weeks post enrollment |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 5 weeks post enrollment |
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| 0 |
| 58 |
| 0 |
| 58 |
| 0 |
| 58 |
| EG001 | 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. | 0 | 57 | 0 | 57 | 0 | 57 |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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