Back to resultsQuitGuide for American Indians: Aims 2 & 3
Primary Purpose
Tobacco Use, Tobacco Use Disorder
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tailored QuitGuide app
Standard QuitGuide app
Sponsored by
About this trial
This is an interventional prevention trial for Tobacco Use
Eligibility Criteria
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
Sites / Locations
- Masonic Cancer Center - University of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Experimental
Placebo Comparator
Arm Label
Aim 2: Tailored App (pilot run of Aim 3)
Aim 3:Tailored App
Aim 3: Standard App
Arm Description
All participants will use the tailored QuitGuide app, a smoking cessation app, downloaded to their personal phone.
Randomized subset of participants will use the tailored QuitGuide app, a smoking cessation app, downloaded to their personal phone.
Randomized subset of participants will use the standard QuitGuide app, a smoking cessation app available to the public, downloaded to their personal phone.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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
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)
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.
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?'
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.'
Full Information
NCT ID
NCT05447156
First Posted
July 1, 2022
Last Updated
October 16, 2023
Sponsor
Masonic Cancer Center, University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT05447156
Brief Title
QuitGuide for American Indians: Aims 2 & 3
Official Title
QuitGuide for American Indians: Aims 2 & 3
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 14, 2022 (Actual)
Primary Completion Date
September 25, 2023 (Actual)
Study Completion Date
July 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masonic Cancer Center, University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use, Tobacco Use Disorder
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Aim 2: All participants in this aim will use the tailored QuitGuide app Aim 3: Participants will be randomized to either the tailored QuitGuide app or the standard version of the QuitGuide app for 5 weeks.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aim 2: Tailored App (pilot run of Aim 3)
Arm Type
Other
Arm Description
All participants will use the tailored QuitGuide app, a smoking cessation app, downloaded to their personal phone.
Arm Title
Aim 3:Tailored App
Arm Type
Experimental
Arm Description
Randomized subset of participants will use the tailored QuitGuide app, a smoking cessation app, downloaded to their personal phone.
Arm Title
Aim 3: Standard App
Arm Type
Placebo Comparator
Arm Description
Randomized subset of participants will use the standard QuitGuide app, a smoking cessation app available to the public, downloaded to their personal phone.
Intervention Type
Behavioral
Intervention Name(s)
Tailored QuitGuide app
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard QuitGuide app
Intervention Description
This is an app available to the public.
Primary Outcome Measure Information:
Title
Frequency of app use
Description
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
2 weeks post enrollment for aim 2 and 5 weeks post enrollment for aim 3
Secondary Outcome Measure Information:
Title
Frequency of app use
Description
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
1 week post-randomization for aim 3/ Not applicable for aim 2
Title
Frequency of interactions with various app features (e.g. quit tips, trigger list) over the 5 weeks
Description
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
2 weeks post enrollment for aim 2 and 5 weeks post enrollment for aim 3
Title
Study attrition measured as percentage of randomized participants that complete the final phone interview at 5 weeks
Description
Percentage of randomized participants that complete the final phone interview at 5 weeks
Time Frame
5 weeks post enrollment aim 3
Title
Frequency of returning saliva sample by 2 weeks post the week 5 interview
Description
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
Title
Usability of App Design measured using System Usability scale (SUS)
Description
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.
Time Frame
5 weeks post enrollment
Title
Acceptability of overall app
Description
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?'
Time Frame
5 weeks post enrollment
Title
Fit of app with culture
Description
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.'
Time Frame
5 weeks post enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dana Caroll, PhD
Organizational Affiliation
Masonic Cancer Center, Univeristy of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Masonic Cancer Center - University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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QuitGuide for American Indians: Aims 2 & 3
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