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Mobile Cessation Support for Latino Smokers

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ClinicalTrials.gov Identifier: NCT03586596
Recruitment Status : Recruiting
First Posted : July 13, 2018
Last Update Posted : September 5, 2018
Sponsor:
Collaborators:
Lombardi Comprehensive Cancer Center
Children's Mercy Hospital Kansas City
University of Kansas
Information provided by (Responsible Party):
Hackensack Meridian Health

Brief 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 (N=618). 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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: The Decídetext program Behavioral: Standard Care Control Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 618 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Decídetext: Mobile Cessation Support for Latino Smokers
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Quitting Smoking

Arm Intervention/treatment
Experimental: The Decídetext program
Participants will receive a tablet-based interactive educational session, 6 months of text-messaging based counseling, which includes prompts to access free pharmacotherapy.
Behavioral: The Decídetext program
Decídetext participants will be directed to the tablet-based software. Participants will receive an interactive education session that will lead them through language-appropriate, culturally-relevant information about stopping smoking, collection of basic smoking history data, and choices/plans about preparing to quit. Quit plans include: 1) choice of quit date, 2) NRT preference, 3) plan to remove smoking cues, 4) identification of trigger situations and 5) choice of suggested coping strategies. Participant data and choices are used to generate a printed 1-page individualized treatment plan. Tablet components, assessment items, audio narrative, brief multimedia instructional video clips, and the printed treatment plan have been developed to address low-literacy levels.

Active Comparator: Standard Care Control
Participants will receive an adapted version of standard printed smoking cessation educational materials from the American Cancer Society and, the National Cancer Institute, which include information about the health risks of smoking, benefits & strategies for quitting and access to free pharmacotherapy by calling a free number.
Behavioral: Standard Care Control
Educational Material provided as of suggested by American Cancer Society and, the National Cancer Institute




Primary Outcome Measures :
  1. Cotinine-verified 7-day point prevalence at 6 months. [ Time Frame: 6 months ]
    Participants who quit will do a cotinine-verified 7-day point prevalence check at Month 6.


Secondary Outcome Measures :
  1. 12- week self-report [ Time Frame: 12 weeks ]
    Participants in both conditions will complete follow-up assessment at the end of the treatment at 12 weeks.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 12 months, or another household member enrolled in the study.
  • If answers no to any question of the Eligibility form.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03586596


Contacts
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Contact: Ciara E. Torres, PhD 551-996-5779 Ciara.Torres@hackensackmeridian.org
Contact: Lisa Sanderson Cox, PhD 913-588-2643 lcox@kumc.edu

Locations
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United States, New Jersey
Hackensack Meridian Health - Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Ciara Torres, PhD    551-996-5779    ciara.torres@hackensackmeridian.org   
Sponsors and Collaborators
Hackensack Meridian Health
Lombardi Comprehensive Cancer Center
Children's Mercy Hospital Kansas City
University of Kansas
Investigators
Layout table for investigator information
Principal Investigator: Ana P Cupertino, PhD Hackensack Meridian Health

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Responsible Party: Hackensack Meridian Health
ClinicalTrials.gov Identifier: NCT03586596     History of Changes
Other Study ID Numbers: Pro2017-0528
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hackensack Meridian Health:
Smokers
Mobile intervention
Latino
Promotores de Salud
Pharmacotherapy
Cultural accomodation
Tobacco use
Health Disparities
Cancer Disparities