Smoking Cessation Clinical Trial
Official title:
Decídetext: Mobile Cessation Support for Latino Smokers
Verified date | April 2024 |
Source | University of Rochester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 457 |
Est. completion date | September 8, 2021 |
Est. primary completion date | September 8, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Hackensack Meridian Health - Hackensack University Medical Center | Hackensack | New Jersey |
United States | University of Kansas Medical Center | Kansas City | Kansas |
United States | University of Rochester Medical Center | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
University of Rochester | Children's Mercy Hospital Kansas City, Lombardi Comprehensive Cancer Center, The University of Kansas Medical Center |
United States,
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* Note: There are 28 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cotinine-verified 7-day point prevalence at 6 months. | Participants who quit will do a cotinine-verified 7-day point prevalence check at Month 6. | 6 months | |
Secondary | 12- week self-report | Participants in both conditions will complete follow-up assessment at the end of the treatment at 12 weeks. | 12 weeks |
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