QuitGuide for American Indians: Aims 2 & 3
Study Details
Study Description
Brief Summary
Aim 2: To assess the preliminary feasibility and acceptability of a tailored smoking cessation app prototype (here forward called tailored QuitGuide) among American Indian (AI) smokers.
Aim 3: To test feasibility, acceptability, and preliminary efficacy of the tailored QuitGuide for smoking cessation among AIs.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Aim 2: Tailored App (pilot run of Aim 3) All participants will use the tailored QuitGuide app, a smoking cessation app, downloaded to their personal phone. |
Behavioral: 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.
|
| Experimental: Aim 3:Tailored App Randomized subset of participants will use the tailored QuitGuide app, a smoking cessation app, downloaded to their personal phone. |
Behavioral: 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.
|
| Placebo Comparator: 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. |
Behavioral: Standard QuitGuide app
This is an app is available to the public.
|
Outcome Measures
Primary Outcome Measures
- Frequency of app use [2 weeks post enrollment for aim 2 and 5 weeks post enrollment for aim 3]
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 Outcome Measures
- Frequency of app use [1 week post-randomization for aim 3/ Not applicable for aim 2]
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.
- Frequency of interactions with various app features (e.g. quit tips, trigger list) over the 5 weeks [2 weeks post enrollment for aim 2 and 5 weeks post enrollment for aim 3]
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.
- 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]
How will this scale be used? how are results reported? Would there be an average/percentage?
- Acceptability of overall app (i.e., how likely would you be to recommend the app) and various app components (e.g. quit tips, trigger list) measured as Likert-scale responses [5 weeks post enrollment]
Acceptability of overall app- will you use a scoring: how is this going to be summarized? various app components (e.g. quit tips, trigger list) measured as Likert-scale - this too broad for ct.gov they will likely reject this comment. We can discard or specifically break into components.
- Fit of app with culture measured as Likert-scale responses [5 weeks post enrollment]
How will this scale be used? how are results reported? Would there be an average/percentage?
Eligibility Criteria
Criteria
Inclusion Criteria:
-
American Indian person based on self-report
-
Age ≥ 18 years
-
Interested in quitting smoking
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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:
- Aim 2
• Does not speak or read English
-
Aim 3
-
Participation in Aim 2
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Masonic Cancer Center - University of Minnesota | Minneapolis | Minnesota | United States | 55455 |
Sponsors and Collaborators
- Masonic Cancer Center, University of Minnesota
Investigators
- Principal Investigator: Dana Caroll, PhD, Masonic Cancer Center, Univeristy of Minnesota
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SPH-2022-30604
- MCC CPRC