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Recruiting NCT05415761

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

No phase Interventional Tobacco Use Cessation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: iCanQuit, iCanQuit+Motiv8, Florida quit line.
Who it may be relevant to
Registry conditions: Tobacco Use Cessation. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

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

Primary outcome measures

  • Smoking Point-Prevalence Abstinence (PPA) [Time frame: Month 6]
Secondary outcome measures (8)
  • Smoking Point-Prevalence Abstinence (PPA) [Time frame: Months 2 and 12]
  • Treatment Satisfaction [Time frame: Month 12]
  • Quality of Life and Well-Being [Time frame: Baseline, and month 6]
  • Self Efficacy [Time frame: Baseline, and month 6]
  • Acceptance [Time frame: Months 2 and 6]
  • Values [Time frame: Months 2 and 6]
  • Motivation [Time frame: Months 2 and 6]
  • Smoking Prolonged Abstinence [Time frame: Months 6 and 12]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Florida — Gainesville

Publications

  • Salloum RG, Bricker JB, Lee JH, Theis RP, Pluta K, Williams MP, Naous J, Mulani SR, Cogle CR, Rubin DA, Fahnlander AM, Nordelo B, Sullivan BM, Bloodworth S, Corbin L, Siler K, Willis D, Carrasquillo O, Dallery J. Comparative effectiveness of mobile health smoking cessation approaches among underserved patients in primary care: Study protocol for the PROMOTE-UP trial. Contemp Clin Trials. 2023 Apr; PMID 36804046

Identifiers

NCT: NCT05415761 · IRB202200918 · IRB202200918 · OCR41824

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗