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Smoking CessationNCT03586596

Mobile Cessation Support for Latino Smokers

A study testing The Decídetext program in people with Smoking Cessation, run by University of Rochester at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 21 years and olderHealthy volunteers can take part
Conditions the study is for
Smoking Cessation
What is being tested?
The Decídetext program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
457 participants
Where
3 sitesUnited States
Study dates
1 Sep 2018to 8 Sep 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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?
Show all 15Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Hackensack Meridian Health - Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • University of Rochester Medical Center

    Rochester, New York, 14642

Other trials in United States

About this study

Official title: Decídetext: Mobile Cessation Support for Latino Smokers

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.

Read the 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.

Being tested
The Decídetext program, Standard Care Control
Keywords
Smokers, Mobile intervention, Latino, Promotores de Salud, Pharmacotherapy, Cultural accomodation, Tobacco use, Health Disparities, Cancer Disparities
Medical subject headings
Smoking Cessation, Tobacco Use

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The Decídetext programBehavioural

    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.

  • Standard Care ControlBehavioural

    Educational Material provided as of suggested by American Cancer Society and, the National Cancer Institute

Study groups in NCT03586596
Study groupRoleWhat they receive
The Decídetext programExperimentalParticipants will receive a tablet-based interactive educational session, 6 months of text-messaging based counseling, which includes prompts to access free pharmacotherapy.
Receives: Behavioral: The Decídetext program
Standard Care ControlActive comparatorParticipants 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.
Receives: Behavioral: Standard Care Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

Secondary outcomes (1)

  1. 12- week self-report

    Participants in both conditions will complete follow-up assessment at the end of the treatment at 12 weeks.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2018
  2. Study start1 Sep 2018
  3. Primary completion8 Sep 2021
  4. Study completion8 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
457 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03586596
Sponsor's protocol ID
Pro2017-0528
Status last verified
Apr 2024
First submitted
2 Jul 2018
Last updated
12 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

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  • 7. Colby S, Ortman J. Projections of the Size and Composition of the U.S. Population: 2014 to 2060: Population Estimates and Projections. 2015. 8. Bethel JW, Schenker MB. Acculturation and smoking patterns among Hispanics: a review. American Journal of Preventive Medicine. 2005;29(2):143-148. 9. Lee D, Fleming L, Arheart K, et al. Smoking rate trends in U.S. occupational groups: The 1987 to 2004 National Health Interview Survey. Journal of Occupational and Environmental Medicine. 2007;49(1):75-81. 10. Wilkinson AV, Spitz MR, Strom SS, et al. Effects of nativity, age at migration, and acculturation on smoking among adult Houston residents of Mexican descent. American Journal of Public Health. 2005;95(6):1043-1049. 11. CDC. CDC Health disparities and inequalities report - United States, 2011. Morbidity and Mortality Weekly Report (MMWR). 2011;60:109-113.

  • Lewin ME, Baxter RJ. America's health care safety net: revisiting the 2000 IOM report. Health Aff (Millwood). 2007 Sep-Oct;26(5):1490-4. doi: 10.1377/hlthaff.26.5.1490.

    PubMed 17848461

  • 17. Maher JE, Rohde K, Dent CW, et al. Is a statewide tobacco quitline an appropriate service for specific populations? Tobacco Control. 2007;16 Suppl 1:i65-70. 18. Zuniga E, Castaneda, X., Averbach, A., & Wallace, S.P. Mexican and Central American immigrants in the United State: Health care access. . Regents of the University of California and the Mexican Secretariat of Health. 2006. 19. CDC. Quitting Smoking Among Adults - United States, 2001 - 2010. Atlanta, GA: Center for Disease Control and Prevention;2011. 20. Soto Mas FG, Papenfuss RL, Jacobson HE, Hsu CE, Urrutia-Rojas X, Kane WM. Hispanic physicians' tobacco intervention practices: a cross-sectional survey study. BMC Public Health. 2005;5:120. 21. Zhu K, Levine RS, Brann EA, Gnepp DR, Baum MK. A population-based case-control study of the relationship between cigarette smoking and nasopharyngeal cancer (United States). Cancer Causes Control. 1995;6(6):507-512.

  • Sherrill W, Crew L, Mayo RB, Mayo WF, Rogers BL, Haynes DF. Educational and health services innovation to improve care for rural Hispanic communities in the USA. Rural Remote Health. 2005 Oct-Dec;5(4):402. Epub 2005 Nov 11.

    PubMed 16283825

  • 26. Foraker RE, Patten CA, Lopez KN, Croghan IT, Thomas JL. Beliefs and attitudes regarding smoking among young adult Latinos: a pilot study. Preventive Medicine. 2005;41(1):126-133. 27. Team. DREGaNDP. Tobacco use in Minnesota: perspectives from Latino communities. Executive summary. Minnesota. : Blue Cross and Blue Shield of Minnesota, Communidades Latinas Unidas en Servicio, Minnesota Partnership for Action Against Tobacco;2006. 28. Bock BC, Niaura RS, Neighbors CJ, Carmona-Barros R, Azam M. Differences between Latino and non-Latino White smokers in cognitive and behavioral characteristics relevant to smoking cessation. Addictive Behaviors. 2005;30(4):711-724. 29. Fiore M, Jaen, CR, Baker, TB. Treating tobacco use and dependence: 2008 update. Rockville, MD: U.S. Department of Health and Human Services; 2008. 30. Cox L, Okuyemi K, Choi W, Ahluwalia J. A review of tobacco use treatments in U.S. ethnic minority populations. American Journal of Health Promotion. 2011;25(5S):S11-S30.

  • 31. Webb M, Rogers BG, Okuyemi K. Smoking cessation among racial/ethnic minorities, 2010-2014. Current Addiction Reports. 2015;2(1):24-32. 32. Leischow SJ, Hill A, Cook G. The effects of transdermal nicotine for the treatment of Hispanic smokers. American Journal of Health Behavior. 1996;20(5):304-311. 33. Woodruff SI, Talavera GA, Elder JP. Evaluation of a culturally appropriate smoking cessation intervention for Latinos. Tobacco Control. 2002;11(4):361-367. 34. Kreps GL, Neuhauser L. New directions in eHealth communication: opportunities and challenges. Patient education and counseling. 2010;78(3):329-336. 35. Cole-Lewis H, Kershaw T. Text messaging as a tool for behavior change in disease prevention and management. Epidemiologic Reviews. 2010;32:56-69. 36. Whittaker R, McRobbie H, Bullen C, Borland R, Rodgers A, Gu Y. Mobile phone-based interventions for smoking cessation. The Cochrane database of systematic reviews. 2012;11.

  • 37. Heron KE, Smyth JM. Ecological momentary interventions: incorporating mobile technology into psychosocial and health behaviour treatments. British journal of health psychology. 2010;15(1):1-39. 38. Kim BH, Glanz K. Text messaging to motivate walking in older African Americans: a randomized controlled trial. American Journal of Preventative Medicine. 2013;44(1):71-75. 39. Gerber BS, Stolley MR, Thompson AL, Sharp LK, Fitzgibbon ML. Mobile phone text messaging to promote healthy behaviors and weight loss maintenance: a feasibility study. Health Informatics Journal. 2009;15(1):17-25. 40. Patrick K, Raab F, Adams MA, et al. A text message-based intervention for weight loss: randomized controlled trial. Journal of Medical Internet Research. 2009;11(1):e1. 41. Rodgers A, Corbett T, Bramley D, et al. Do u smoke after txt? Results of a randomised trial of smoking cessation using mobile phone text messaging. Tobacco Control. 2005;14(4):255-261.

  • Naditz A. Medication compliance--helping patients through technology: modern "smart" pillboxes keep memory-short patients on their medical regimen. Telemed J E Health. 2008 Nov;14(9):875-80. doi: 10.1089/tmj.2008.8476. No abstract available.

    PubMed 19062349

  • 43. Krishna S, Boren SA. Diabetes self-management care via cell phone: a systematic review. Journal of diabetes science and technology. 2008;2(3):509-517. 44. Free C, Phillips G, Watson L, et al. The effectiveness of mobile-health technologies to improve health care service delivery processes: a systematic review and meta-analysis. PLOs Medicine. 2013;10(1):e1001362. 45. Kong G, Ells D, Camenga D, Krishnan-Sarin S. Text messaging-based smoking cessation intervention: A narrative review. Addictive Behaviors. 2014;39(5):907-917. 46. De Leon E, Fuentes L, Cohen J. Characterizing periodic messaging interventions across health behaviors and media: systematic review. Journal of Medical Internet Research. 2014;16(3):e93. 47. Brendryen H, Drozd F, Kraft P. A digital smoking cessation program delivered through internet and cell phone without nicotine replacement (happy ending): randomized controlled trial. Journal of Medical Internet Research. 2008;10(5):e51.

  • 48. Abroms L, Boal A, Simmens S, Mendel J, Windsor R. A randomized trial of Text2Quit: a text messaging program for smoking cessation. American Journal of Preventative Medicine. 2014;47(3):242-250. 49. Fox S, Livingston G. Latinos Online: Hispanics with lower level of education and English proficiency remain largely disconnected from the Internet. Washington, DC: Pew Internet and American Life Project & Pew Hispanic Center;2007. 50. Zickuhr K. Generations 2010. Washington, D.C.2010. 51. Tarnowski J. Opiniones 2007: Hispanics respond well to direct mail, text messaging. Vertis Communication 2007. 52. Ahlers-Schmidt CR, Ablah E, Rogers N, et al. Low-Income Urban Latino Parents' Perceptions of Immunization Text Reminders. Ethnicity and Disease. 2013:229-235. 53. Group TTRI. Tobacco research implementation plan. Priorities for tobacco research beyond the year 2000. . Bethesda, MD: National Cancer Institute, National Institute of Health.;1998.

  • 54. Free C, Phillips G, Galli L, et al. The effectiveness of mobile-health technology-based health behaviour change or disease management interventions for health care consumers: a systematic review. PLoS Med. 2013;10(1):e1001362. 55. Cupertino AP, Cruz K, Ramirez-Mantilla M, et al. Interacting with Latino smokers via Text-Messaging Paper presented at: SRNT 22nd Annual Meeting2016; Chicago. 56. Cartujano F, Perales J, Ramirez M, et al. "Every day i think about your messages": assessing text-messaging interaction with Latino smokers. Paper presented at: SRNT 22nd Annual Meeting2016; Chicago. 57. Rimer BK. Cancer control research 2001. Cancer Causes & Control. 2000;11(3):257-270. 58. Bandura A. Social cognitive theory: an agentic perspective. Annual Review of Psychology. 2001;52:1-26. 59. Hawkins RP, Kreuter M, Resnicow K, Fishbein M, Dijkstra A. Understanding tailoring in communicating about health. Health Education Research. 2008;23(3):454-466.

  • 60. Bordin ES. Theory and research on the therapeutic working alliance: New directions. The working alliance: Theory, research, and practice. 1994:13-37. 61. Ardito RB, Rabellino D. Therapeutic alliance and outcome of psychotherapy: Historical excursus, measurements, and prospects for research. Frontiers in psychology. 2011;2(1):270. 62. Horvath AO, Symonds BD. Relation between working alliance and outcome in psychotherapy: A meta-analysis. Journal of counseling psychology. 1991;38(2):139. 63. Cupertino AP, Berg C, Azor Hui SK, Richter K, Gajewski BJ, Ellerbeck EF. Change in Self-Efficacy, Autonomous and Controlled Motivation Predicting Smoking Cessation. Society for Research on Nicotine and Tobacco; 2010; Baltimore, MD.

  • 64. Suarez N, Cox L, Richter K, et al. Success of "Promotores de Salud" in identifying immigrant Latino smokers and developing quit plans In: Caron R, Merrick J, eds. Building Community Capacity: Minority and Immigrant Populations. Hauppauge, New York: Nova Science Publishers 2012:343. 65. Cupertino AP, Fernandez C, Reynoso E, et al. Reinforcing promotores de salud and a culturally appropriate quit smoking program. Promotores de Salud Annual Conference; 2010; San Francisco, CA. 66. Fernandez C, Bullard E, Cupertino AP, Morgan A, Mendoza I, Garrett S. Promotores de salud: community-based model to address health disparities among Latinos. KDHE Center for Health Disparities Conference.; 2009; Topeka, KS. 67. Saint-Elin M, Bravo J, Estrella O, et al. Promotores de salud program in Southwest Kansas. Kansas City, KS: Juntos Center for Advancing Latino Health February 2012.

  • 68. Sechrest L. Opening access to tobacco dependence treatment resources for Spanish-speaking cessation providers in the U.S. Mexico border region: promotores contra el tabaco en la frontera. Tucson, Arizona: The University of Arizona;2006. 69. Cupertino AP, Wick JA, Richter KP, Mussulman L, Nazir N, Ellerbeck EF. The impact of repeated cycles of pharmacotherapy on smoking cessation: a longitudinal cohort study. Archives of Internal Medicine. 2009;169(20):1928-1930. PMCID: 2826277 70. Cupertino AP, Richter K, Cox LS, et al. Feasibility of a Spanish / English computerized decision aid to facilitate smoking cessation efforts in underserved communities. Journal of Health Care for the Poor and Underserved 2010;21:504-517. PMID: 20453353 71. Engelman KK, Cupertino AP, Daley CM, et al. Engaging diverse underserved communities to bridge the mamography divide. Public Health. 2011;11:47. PMCID: 3036625.

Questions about this trial

What is this clinical trial studying?

A study testing The Decídetext program in people with Smoking Cessation, run by University of Rochester at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cotinine-verified 7-day point prevalence at 6 months. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03586596, which also lists 30 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.

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Mobile Cessation Support for Latino Smokers | AzTrials