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OpenTrials
Completed

NCT Number: NCT05447156

QuitGuide for American Indians: Aims 2 & 3

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

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Key information

Conditions

Tobacco Use Behavior Chemically-Induced Disorders Mental Disorders Substance-Related Disorders Tobacco Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Masonic Cancer Center - University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Standard QuitGuide app

Behavioral

This is an app available to the public.

Primary outcomes

  1. Frequency of App Use

    Time frame: 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 outcomes

  1. Study Attrition Measured as Percentage of Randomized Participants That Complete the Final Phone Interview at 5 Weeks

    Time frame: 5 weeks post enrollment aim 3

    Percentage of randomized participants that complete the final phone interview at 5 weeks

  2. Frequency of Returning Saliva Sample by 2 Weeks Post the Week 5 Interview

    Time frame: 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)

  3. Usability of App Design Measured Using System Usability Scale (SUS)

    Time frame: 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.

  4. Acceptability of Overall App

    Time frame: 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.

  5. Fit of App With Culture

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Masonic Cancer Center, University of Minnesota

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 7, 2022
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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