QuitGuide for American Indians: Aims 2 & 3

NCT05447156 | Completed Results

• 2 other identifiers: SPH-2022-30604MCC CPRC
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tobacco Use; Tobacco Use Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Study Attrition Measured as 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

  5 weeks post enrollment aim 3

• Usability of App Design Measured Using System Usability Scale (SUS)

  5 weeks post enrollment

• Acceptability of Overall App

  5 weeks post enrollment

• Fit of App With Culture

  5 weeks post enrollment

Study Arms (2)

Aim 3:Tailored App

EXPERIMENTAL

Randomized subset of participants will use the tailored QuitGuide app, a smoking cessation app, downloaded to their personal phone.

Behavioral: Tailored QuitGuide app

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.

Behavioral: Standard QuitGuide app

Interventions

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.

Aim 3:Tailored App

Standard QuitGuide app BEHAVIORAL

This is an app available to the public.

Aim 3: Standard App

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

Masonic Cancer Center - University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Tobacco Use; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Dana Mowls Carroll, Ph.D., M.P.H.
• Organization: Masonic Cancer Center

dcarroll@umn.edu

612-624-4511

Study Officials

• Dana Caroll, PhD

  Masonic Cancer Center, Univeristy of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Aim 3: Participants will be randomized to either the tailored QuitGuide app or the standard version of the QuitGuide app for 5 weeks.

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 7, 2022
• Study Start: December 14, 2022
• Primary Completion: September 25, 2023
• Study Completion: November 29, 2023
• Last Updated: April 11, 2025
• Results First Posted: April 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)