QuitGuide for American Indians: Aims 2 & 3

Masonic Cancer Center, University of Minnesota115 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

115

Conditions

Tobacco Use Tobacco Use Disorder

Interventions

Tailored QuitGuide appBEHAVIORAL

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 appBEHAVIORAL

This is an app available to the public.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Masonic Cancer Center - University of Minnesota

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

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

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

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.

Data from ClinicalTrials.gov

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