Tobacco Use Cessation
Conditions
Keywords
tobacco use intervention, mobile health aids
Brief 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.
Detailed 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.
Interventions
BEHAVIORALiCanQuit
iCanQuit is a smoking cessation smart phone application that uses acceptance and commitment therapy (ACT) approach, a cognitive behavioral treatment
BEHAVIORALiCanQuit+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)
BEHAVIORALFlorida 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.
Sponsors
University of Florida
Patient-Centered Outcomes Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Randomized to one of the 3 study arms, using a 1:1:1 allocation scheme
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Smoking Point-Prevalence Abstinence (PPA) | Month 6 | negative CO breath sample ≤ 5 ppm using an iCO monitor, and self-reported abstinence from smoking in the last 7 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Smoking Point-Prevalence Abstinence (PPA) | Months 2 and 12 | negative CO breath sample ≤ 5 ppm using an iCO monitor, and self-reported abstinence from smoking in the last 7 days |
| Treatment Satisfaction | Month 12 | 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. |
| Quality of Life and Well-Being | Baseline, and month 6 | 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. |
| Self Efficacy | Baseline, and month 6 | 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. |
| Acceptance | Months 2 and 6 | 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. |
| Values | Months 2 and 6 | 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. |
| Motivation | Months 2 and 6 | 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. |
| Smoking Prolonged Abstinence | Months 6 and 12 | Self-reported abstinence from the date of the last time a cigarette was smoked. |
Countries
United States
Contacts
CONTACTJesse Dallery, PhD
CONTACTRamzi Salloum, PhD
PRINCIPAL_INVESTIGATORJesse Dallery, PhD
University of Florida
PRINCIPAL_INVESTIGATORRamzi Salloum, PhD
University of Florida
Outcome results
None listed