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Clinical Trial Summary

The purpose of the proposed project is to evaluate an automated mobile phone-based CM approach that will allow socioeconomically disadvantaged individuals to remotely benefit from financial incentives for smoking cessation. The investigators have previously combined technologies including 1) portable carbon monoxide monitors that connect with mobile phones to remotely verify smoking abstinence, 2) facial recognition software to confirm participant identity during breath sample submissions, and 3) remote delivery of incentives automatically triggered by biochemical confirmation of self-reported abstinence. This automated CM approach will be evaluated in a randomized controlled trial that includes 532 socioeconomically disadvantaged males and females seeking smoking cessation treatment. Participants will be randomly assigned to either telephone counseling and nicotine replacement therapy (standard care [SC]) or SC plus a mobile financial incentives intervention (CM) for biochemically-confirmed abstinence. Participants will be followed for 26 weeks after a scheduled quit attempt. Biochemically-verified 7-day point prevalence abstinence at 26 weeks post-quit will be the primary outcome variable. Cost-effectiveness will be evaluated to inform policy-related decisions. Potential mobile CM treatment mechanisms, including self-efficacy, motivation, and treatment engagement, will be explored to optimize future versions of the intervention.


Clinical Trial Description

The primary purpose of the proposed project is to evaluate an automated smartphone-based CM approach that will allow socioeconomically disadvantaged adults to earn financial incentives for smoking cessation without requiring in-person attendance for abstinence verification. The investigators have combined technologies: 1) low-cost carbon monoxide monitors that connect with mobile phones to remotely verify smoking abstinence, 2) facial recognition software to verify the identity of participants while they provide a breath sample, and 3) remote and automated delivery of incentives to a credit card triggered by biochemical confirmation of self-reported smoking abstinence. This CM approach will be evaluated in a randomized controlled trial of 532 socioeconomically disadvantaged males and females seeking smoking cessation treatment. Participants will be randomly assigned to telephone counseling plus nicotine replacement therapy (standard care [SC]) or SC plus a 12-week smartphone-based financial incentives intervention (CM). Participants will be followed for 26 weeks after a scheduled quit attempt, which is 14 weeks after incentives have ended. Cost-effectiveness will be evaluated to inform policy and health care decisions. Potential CM treatment mechanisms, including self-efficacy, motivation, and treatment engagement will be identified to optimize future versions of the intervention. The specific aims are: 1) to evaluate the impact of an automated, mobile phone-based CM approach relative to SC on smoking cessation among socioeconomically disadvantaged adults, 2) to compare the cost-effectiveness of two smoking cessation interventions (CM vs. SC), and 3) to identify mobile CM treatment mechanisms such as motivation to quit, self-efficacy for quitting, and treatment engagement/adherence. The proposed study will evaluate an intervention approach that increases the reach of a potentially effective and cost-effective smoking cessation intervention for socioeconomically disadvantaged smokers. This proposed study is also going to be conducting recruitment nationwide. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04881630
Study type Interventional
Source University of Oklahoma
Contact Shannon Gwin, Ph.D.
Phone 405-271-8001
Email Shannon-Gwin@ouhsc.edu
Status Recruiting
Phase N/A
Start date November 8, 2022
Completion date October 31, 2025

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