Randomized Clinical Trial of A Culturally Aligned Digital Smoking Cessation Resource for American Indian Persons
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Smoking Cessation
- Sponsor
- Masonic Cancer Center, University of Minnesota
- Enrollment
- 416
- Locations
- 1
- Primary Endpoint
- Percent of participants that are biochemically confirmed 7-day abstinence from from all combustible tobacco products with a negative breath CO test
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
Brief Summary
The aim of this clinical trial is to test the efficacy of a culturally aligned digital smoking cessation resource for American Indian persons who smoke, via a remotely conducted randomized controlled trial.
Detailed Description
This is a two-arm, parallel group, randomized controlled clinical trial. Eligible participants (n=416) will be randomized to either the culturally aligned resource or the general audience version. Participants will use the assigned resource for 6 months, and partake in surveys at baseline, and 1, 3 and 6 months, during which they will be asked several questions related to use of their assigned resource, and smoking behavior. Carbon monoxide (CO) in exhaled breath will be collected at 1, 3 and 6 months using iCO™ Smokerlyzer® (https://www.icoquit.com/us/).
Investigators
Eligibility Criteria
Inclusion Criteria
- •AI race based on self-report;
- •≥ 18 years of age via photo ID confirmation;
- •Average smoked cigarettes per day, ≥ 3 in the past 30 days;
- •considering or willing to make a quit attempt;
- •self-report having daily access to their own iPhone/Android smartphone or tablet that allows for messaging use;
- •able to read and speak English.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Percent of participants that are biochemically confirmed 7-day abstinence from from all combustible tobacco products with a negative breath CO test
Time Frame: 6 months
Percent of participants that are biochemically confirmed 7-day abstinence from all combustible tobacco products (defined as self-reported abstinence during the past seven days \[not even a puff of cigarettes, cigars, hookah, or pipe tobacco\] with a negative breath CO test ≤ 4 ppm).
Secondary Outcomes
- Percent of participants that are biochemically-confirmed 7-day abstinence(1 and 3 months)
- Percent of participants that self-report 24-hour abstinence(1, 3, and 6 months)
- Percent of participants that self-report 7-day abstinence(1, 3, and 6 months)
- Percent of participants that self-report 30-day abstinence(3 and 6 months)
- Mean cigarettes per day in past 7 days(1, 3, and 6 months)
- Number of 24-hour quit attempts in past 30 days(1, 3, and 6 months)
- Percent of participants that used nicotine replacement therapy and pharmacotherapy(1, 3, and 6 months)
- Percent of participants that used other behavioral support(1, 3, and 6 months)
- Percent of participants that used other commercial tobacco products(1, 3, and 6 months)
- Mean cigarette dependence(1, 3, and 6 months)