Comparative Effectiveness of Mobile Health Smoking Cessation Approaches Among Underserved Patients in Primary Care

Tobacco Use Cessation Clinical Trial

— PROMOTE-UP  

Official title:

Comparative Effectiveness of Mobile Health Smoking Cessation Approaches Among Underserved Patients in Primary Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05415761
• Other study ID #: IRB202200918
• Secondary ID: OCR41824
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2024
• Source: University of Florida
• Contact: Jesse Dallery, PhD
• Phone: 352-273-2182
• Email: dallery[@]ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the comparative effectiveness of three smoking cessation therapies: mobile health (mHealth) application iCanQuit, mHealth application iCanQuit + Motiv8, and the Florida quit line.

Description:

The research team will recruit 1,332 adult patients who smoke from primary care clinics in North Central Florida, focusing on: (a) the relative effectiveness of the 3 treatments in adult patients who smoke cigarettes, in underserved urban and rural primary care settings. The team will assign patients by chance to one of the 3 treatments. Smoking cessation will be confirmed with a breath test (measured at 2, 6, and 12 months). The study will measure the effects of these treatments in based on gender, race, ethnicity, rurality, and social vulnerability; (b) their effects on patients' quality of life, self-confidence in quitting, and satisfaction with the treatments; and (c) their impact on patients' reported levels of motivation, commitment to values, and acceptance of triggers for smoking.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1332
• Est. completion date: December 31, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• =21 years old

• Referred by the provider via Ask-Advise-Connect

• Receiving care at one of the participating clinics

• Daily access to their own smart phone (the study team will provide assistance to patients without a phone to obtain one through aid programs for low-income patients)

• No household members already enrolled

Exclusion Criteria:

• Unstable medical or psychiatric illness

Related Conditions & MeSH terms

• Tobacco Use Cessation

Intervention

Behavioral:
• iCanQuit
iCanQuit is a smoking cessation smart phone application that uses acceptance and commitment therapy (ACT) approach, a cognitive behavioral treatment
• iCanQuit+Motiv8
iCanQuit + Motiv8 is a integrated version of iCanQuit (Cognitive Behavioral Therapy smoking cessation therapy application) with Motiv8 (a contingency management program that rewards decreased smoking determined by measuring CO levels of participant)
• Florida quit line
An evidence-based, existing smoking cessation healthcare option recommended by the U.S. clinical practice that connects active smokers to trained quit coaches via referral by their providers.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking Point-Prevalence Abstinence (PPA)	negative CO breath sample = 5 ppm using an iCO monitor, and self-reported abstinence from smoking in the last 7 days	Month 6
Secondary	Smoking Point-Prevalence Abstinence (PPA)	negative CO breath sample = 5 ppm using an iCO monitor, and self-reported abstinence from smoking in the last 7 days	Months 2 and 12
Secondary	Treatment Satisfaction	5-item scale measuring treatment by interest, usefulness, concern with privacy, how easy to understand, and satisfaction. Items will be measured on a 0-10 point scale, with higher scores corresponding to greater acceptability.	Month 12
Secondary	Quality of Life and Well-Being	World Health Organization Quality of Life-BREF (WHOQOL-BREF): 26-item scale that measures quality of life. Items are rated on a 5-point Likert scale (low score of 1 to high score of 5), with a higher score indicating a higher quality of life.	Baseline, and month 6
Secondary	Self Efficacy	Self-Efficacy Questionnaire (SEQ-12): 12-item scale. Items are rated on a 5-point Likert scale (low score of 1 to high score of 5), with higher scores indicating greater self-efficacy.	Baseline, and month 6
Secondary	Acceptance	9-item physical sensations subscale of the Avoidance and Inflexibility Scale. Items are rated on a 5-point Likert scale (low score of 1 to high score of 5), with higher scores reflecting more inflexibility/avoidance in the presence of difficult smoking-related thoughts, feelings, and sensations.	Months 2 and 6
Secondary	Values	Valuing Questionnaire (VQ): 10-item measure assessing the extent to which one lives consistently with their values, including Progress and Obstruction subscales. Both subscales total scores range from 0 to 30. A psychologically healthier score is indicated by a higher score on the Progress scale along with a lower score on the Obstructions scale.	Months 2 and 6
Secondary	Motivation	Motivational Engagement Questionnaire: 5-item measure. Items are rated on a 7-point Likert scale (low score of 1 to high score of 7), with higher scores indicating more motivation to quit smoking.	Months 2 and 6
Secondary	Smoking Prolonged Abstinence	Self-reported abstinence from the date of the last time a cigarette was smoked.	Months 6 and 12