Health TrialsbyHealthPanel

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

ConditionTobacco Use Cessation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorUniversity of Florida

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

≥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)

Disqualifiers

Unstable medical or psychiatric illness

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

1,332 Participants
are divided into 3 treatment groups
Group A: iCanQuitActive comparator 1 intervention
Group B: iCanQuit+Motiv8Active comparator 1 intervention
Group C: Florida quit lineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Smoking Point-Prevalence Abstinence (PPA)

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

Time frame
Month 6

Secondary outcomes

1

Smoking Point-Prevalence Abstinence (PPA)

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

Time frame
Months 2 and 12
2

Treatment Satisfaction

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.

Time frame
Month 12
3

Quality of Life and Well-Being

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.

Time frame
Baseline, and month 6
4

Self Efficacy

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.

Time frame
Baseline, and month 6

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Florida

Lead sponsor

Patient-Centered Outcomes Research Institute

Collaborator

Source ClinicalTrials.gov
Apply now