NCT05447156

QuitGuide for American Indians: Aims 2 & 3

Completed NA Results posted Last updated 11 April 2025

What this trial tests

NA trial testing Tailored QuitGuide app in Tobacco Use in 115 participants. Completed in 29 November 2023.

Timeline

14 December 2022

Primary endpoint
25 September 2023

29 November 2023

Quick facts

Lead sponsor	Masonic Cancer Center, University of Minnesota
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	115
Start date	14 December 2022
Primary completion	25 September 2023
Estimated completion	29 November 2023
Sites	1 location across United States

Drugs / interventions tested

• Tailored QuitGuide app
• Standard QuitGuide app

Conditions studied

• Tobacco Use — all drugs for Tobacco Use →
• Tobacco Use Disorder — all drugs for Tobacco Use Disorder →

Sponsor

Masonic Cancer Center, University of Minnesota

Who can join

18 and older, any sex, with Tobacco Use or Tobacco Use Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Frequency of App Use Primary · 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.

5 weeks post enrollment

Group	Value	95% CI
Aim 3:Tailored App	15.3	± 15.5
Aim 3: Standard App	14.9	± 17.8

1 week post randomization

Group	Value	95% CI
Aim 3:Tailored App	4.3	± 5.1
Aim 3: Standard App	3.7	± 3.6

Study Attrition Measured as Percentage of Randomized Participants That Complete the Final Phone Interview at 5 Weeks Secondary · 5 weeks post enrollment aim 3

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

Group	Value	95% CI
Aim 3:Tailored App	55
Aim 3: Standard App	53

Frequency of Returning Saliva Sample by 2 Weeks Post the Week 5 Interview Secondary · 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)

Group	Value	95% CI
Aim 3:Tailored App	35
Aim 3: Standard App	31

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

Group	Value	95% CI
Aim 3:Tailored App	72.4	± 15.6
Aim 3: Standard App	71.9	± 13.3

Acceptability of Overall App Secondary · 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.

Group	Value	95% CI
Aim 3:Tailored App	5.6	± 1.6
Aim 3: Standard App	4.9	± 1.6

Fit of App With Culture Secondary · 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.

Group	Value	95% CI
Aim 3:Tailored App	3.9	± 0.9
Aim 3: Standard App	3.1	± 1.1

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.