Mobile Cessation Support for Latino Smokers (NCT03586596) | Clinical Trial Compass
CompletedNot Applicable
Mobile Cessation Support for Latino Smokers
United States457 participantsStarted 2018-09-01
Plain-language 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.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Are you Hispanic or Latino?
* Do you know how to read and speak English and/or Spanish?
* Are you at least 21 years old?
* Have you smoked cigarettes for at least 6 months?
* Within a typical week, how many days do you smoke (even a puff)?
* Within a typical week, how many days do use other tobacco products?
* Are you interested in quitting smoking in the next 30 days?
* Are you currently participating in any other smoking cessation program or taking any type of medication to quit smoking?
* Is any household member participating in this study?
* Are you pregnant, breast-feeding or planning to become pregnant in the next year?
* Are you planning to move out of your current address in the following six months?
* Do you have an active cellphone with unlimited text messaging capability?
* Are you willing to come to 2 study visit, at the beginning and 6 month, and get at least 1 phone calls between visits?
* Do you know how to send/read text messages?
* Is the participant ELIGIBLE? If NOT ELIGIBLE, complete demographics If ELIGIBLE, complete contact information.
Exclusion Criteria:
* Include plans to move from New Jersey in the next 6 months
* If another household member enrolled in the study.
* If answers no to any question of the Eligibility form.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cotinine-verified 7-day point prevalence at 6 months.