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Clinical Trial Summary

The primary aim of this study is to examine the efficacy of Decídetexto, an innovative mobile smoking cessation intervention that incorporates two elements: 1) a tablet-based e-Health platform that collects personal smoking-related information to support the development of an individualized quit plan and guides the ensuing text messaging program; and 2) a 12-week text messaging "skills-based counseling" (I.e, behavioral support) program that includes educational information, behavioral strategies, motivational messaging, and pharmacotherapy support driven by information obtained from both the tablet program and the user's text messages. The investigators will evaluate its efficacy relative to a standard care condition that provides high quality printed smoking cessation materials along with referral to telephone quit line counseling. Participants in both groups are given access to free pharmacotherapy via a toll-free study number. Experienced Promotores de Salud (Community Health Workers) will use community and clinic-based outreach to recruit Latino smokers into the study. Participants in both conditions will complete follow-up assessment at the end of treatment (Week 12) and Month 6 (primary outcome). Our hypothesis is that at month 6, smokers in Decídetexto will have significantly higher cotinine-verified 7-day point prevalence abstinence (no cigarettes in the past 7 days) than smokers in the control arm.


Clinical Trial Description

Latinos are less likely than non-Hispanic whites to have access to healthcare, to have knowledge of existing smoking cessation resources, to receive advice to stop smoking, and to utilize pharmacotherapy to stop smoking. Despite these marked tobacco-related disparities, there is a lack of effective interventions designed for the Latino community. Mobile technology provides a promising method for overcoming barriers and providing culturally congruent treatment to Latino smokers. Implementation of mobile interventions among Latinos remains minimal despite the fact that Latinos are the fastest adopters of mobile technology, utilizing smartphones and text messaging at a higher rate than non-Hispanic whites do. An effective, culturally appropriate intervention using mobile technologies methods with the potential for widespread adoption by clinic and community-based service providers could dramatically increase reach and impact on Latino health. Decídetext is a culturally congruent method for increasing access to cessation services for Latino smokers and helping them develop, implement, and follow a personalized quit plan. If successful, this intervention could be readily implemented in different settings including community settings, clinics, pharmacies, emergency rooms, and clinic waiting areas and reduce treatment disparities, reduce tobacco-related morbidity and mortality, and improve the health and quality of life for approximately 9 million of Latino smokers in the United States. Aim 1. To evaluate the impact of the culturally accommodated Decídetext program versus standard care on smoking abstinence at Month 6 among Latino smokers. At Month 6, smokers in Decídetext will have significantly higher cotinine-verified 7-day point prevalence abstinence (no cigarettes in the past 7 days) than smokers in the control arm. Program efficacy also will be examined at Week 12 (end of treatment) to assess mechanisms of change, and Month 12 to provide extended outcome data. Aim 2. To assess therapeutic alliance, pharmacotherapy utilization, and self-efficacy as mediators of the presumed treatment effect on cotinine-verified 7-day smoking abstinence at Month 6 among Latino smokers. Our hypothesis is that Decídetext will have greater efficacy for smoking cessation than standard care by increasing therapeutic alliance, utilization of pharmacotherapy, and self-efficacy to quit. Aim 3. To conduct a process evaluation that can inform findings and future improvements. The evaluation of Decídetext includes: 1) satisfaction with the program and its components; 2) text-message system utilization patterns and common content themes in text message interactions among participants. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03586596
Study type Interventional
Source University of Rochester
Contact
Status Completed
Phase N/A
Start date September 1, 2018
Completion date September 8, 2021

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