QuitGuide for American Indians: Aims 2 & 3

Tobacco Use Disorder Clinical Trial

Official title:

QuitGuide for American Indians: Aims 2 & 3

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05447156
• Other study ID #: SPH-2022-30604
• Secondary ID: MCC CPRC
• Status: Completed
• Phase: N/A
• Start date: December 14, 2022
• Est. completion date: November 29, 2023

Study information

• Verified date: February 2024
• Source: Masonic Cancer Center, University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim 2: To assess the preliminary feasibility and acceptability of a tailored smoking cessation app prototype (here forward called tailored QuitGuide) among American Indian (AI) smokers.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 29, 2023
• Est. primary completion date: September 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• Aim 2

• Does not speak or read English

• Aim 3

• Participation in Aim 2

• 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

Related Conditions & MeSH terms

• Tobacco Use
• Tobacco Use Disorder

Intervention

Behavioral:
• Tailored QuitGuide app
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
This is an app available to the public.

Locations

Country	Name	City	State
United States	Masonic Cancer Center - University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 weeks post enrollment for aim 2 and 5 weeks post enrollment for aim 3
Secondary	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.	1 week post-randomization for aim 3/ Not applicable for aim 2
Secondary	Frequency of interactions with various app features (e.g. quit tips, trigger list) over the 5 weeks	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.	2 weeks post enrollment for aim 2 and 5 weeks post enrollment for aim 3
Secondary	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	5 weeks post enrollment aim 3
Secondary	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)	5 weeks post enrollment aim 3
Secondary	Usability of App Design measured using System Usability scale (SUS)	Scores for each question (1-5) are added together for an overall score and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100 and presented as percentile rankings. Mean and standard deviations or medians and ranges of percentile rankings will be calculated.	5 weeks post enrollment
Secondary	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?' and 'Would you be interested in using the app in the future if needed?'	5 weeks post enrollment
Secondary	Fit of app with culture	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' and ' The app makes me feel more connected to my American Indian culture such as its history, traditions, and customs.'	5 weeks post enrollment