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NCT Number: NCT05415761

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

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.

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Key information

Conditions

Tobacco Use Cessation Behavior Health Behavior

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32610, United States

Location status: Recruiting

Location contact

Ashley Dwarka

CONTACT

[email protected]

352-294-8417

Jesse Dallery, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iCanQuit

Behavioral

iCanQuit is a smoking cessation smart phone application that uses acceptance and commitment therapy (ACT) approach, a cognitive behavioral treatment

iCanQuit+Motiv8

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Smoking Point-Prevalence Abstinence (PPA)

    Time frame: Month 6

    negative CO breath sample ≤ 5 ppm using an iCO monitor, and self-reported abstinence from smoking in the last 7 days

Secondary outcomes

  1. Smoking Point-Prevalence Abstinence (PPA)

    Time frame: 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

  2. Treatment Satisfaction

    Time frame: 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.

  3. Quality of Life and Well-Being

    Time frame: 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.

  4. Self Efficacy

    Time frame: 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.

  5. Acceptance

    Time frame: 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.

  6. Values

    Time frame: 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.

  7. Motivation

    Time frame: 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.

  8. Smoking Prolonged Abstinence

    Time frame: Months 6 and 12

    Self-reported abstinence from the date of the last time a cigarette was smoked.

Study contacts

Contact information is provided by the study sponsor or research team.

Jesse Dallery, PhD

CONTACT

[email protected]

352-273-2182

Ramzi Salloum, PhD

CONTACT

[email protected]

352-294-4997

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Acronym: PROMOTE-UP

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 13, 2022
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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