QuitGuide for American Indians: Aims 2 & 3

Not Applicable

Completed

• Conditions: Tobacco Use Disorder; Tobacco Use
• Interventions: Behavioral: Standard QuitGuide app; Behavioral: Tailored QuitGuide app

• Registration Number: NCT05447156
• Lead Sponsor: Masonic Cancer Center, University of Minnesota

Brief Summary

Aim 3: To test feasibility, acceptability, and preliminary efficacy of the tailored QuitGuide for smoking cessation among AIs.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-01
• Study First Submitted QC: 2022-07-01
• Study First Posted: 2022-07-07
• Study Start: 2022-12-14
• Primary Completion: 2023-09-25
• Study Completion: 2023-11-29
• Results First Submitted: 2024-12-05
• Status Verified: 2025-03
• Results First Submitted QC: 2025-03-25
• Last Update Submitted: 2025-03-25
• Results First Posted: 2025-04-11
• Last Update Posted: 2025-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aim 3: Standard App	Standard QuitGuide app	Randomized subset of participants will use the standard QuitGuide app, a smoking cessation app available to the public, downloaded to their personal phone.
Aim 2: Tailored App (pilot run of Aim 3)	Tailored QuitGuide app	All participants will use the tailored QuitGuide app, a smoking cessation app, downloaded to their personal phone.
Aim 3:Tailored App	Tailored QuitGuide app	Randomized subset of participants will use the tailored QuitGuide app, a smoking cessation app, downloaded to their personal phone.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Masonic Cancer Center - University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States