Comparative Effectiveness of Mobile Health Smoking Cessation Approaches Among Underserved Patients in Primary Care (PROMOTE-UP)

University of Florida

Status: Enrolling

Conditions: Tobacco Use Cessation

Treatments: Behavioral: iCanQuit+Motiv8; Behavioral: Florida quit line; Behavioral: iCanQuit

Study type: Interventional

Funder types: Other

Identifiers

NCT05415761

IRB202200918

OCR41824 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,332 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,332 participants in 3 patient groups

iCanQuit

Active Comparator group

Description:

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.

Treatment:

Behavioral: iCanQuit

iCanQuit+Motiv8

Active Comparator group

Description:

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.

Treatment:

Behavioral: iCanQuit+Motiv8

Florida quit line

Active Comparator group

Description:

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.

Treatment:

Behavioral: Florida quit line