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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT05415761
Status
Recruiting
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Conditions

  • Tobacco Use Cessation

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
May 15, 2023
Status verified
Nov 2025
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
1,332 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: iCanQuit
    iCanQuit is a modern, cognitive behavioral treatment which promotes cessation through greater acceptance of triggers for smoking and commitment to personal values. It is a smart phone-based acceptance and commitment therapy (ACT). For patients randomized to the iCanQuit arm (444 total), research staff will assist in downloading the app onto the patient's phone.
  • Active Comparator: iCanQuit+Motiv8
    Motiv8 is an internet-and smart phone-based contingency management (CM) intervention. Motiv8 verifies smoking status via a hand-held breath carbon monoxide (CO) monitor that is connected to a smart phone. For patients randomized to the iCanQuit+Motiv8 arm (444 total), research staff will assist in downloading the combined pp and connecting the iCO to the patient's phone. Smokers will also be asked to complete the first 4 iCanQuit modules, which contain exercises designed to prepare the users for their quit day. The end of the preparation phase will also mark each patient's quit date. During the intervention (7 weeks), participants will be considered abstinent from smoking if their breath CO sample is ≤ 5 ppm or if the CO value has decreased by 5% per hour from the last sample provided.
  • Active Comparator: Florida quit line
    The Florida quit line provides telephone counseling for smoking cessation. Patients randomized to the Florida quit line arm (444 total) will be enrolled after contact information is sent electronically.

Primary Outcome Measure

Smoking Point-Prevalence Abstinence (PPA) [ Time Frame: Month 6 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32610
Ashley Dwarka
[email protected]
352-294-8417
Jesse Dallery, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Florida· Gainesville, FL

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