Using Technology to Help Low-income and Latino Smokers Quit

Overview

The Institute for International Internet Interventions for Health (i4Health) at Palo Alto University proposes to develop digital tools specifically designed to help low income English-speaking and Spanish-speaking smokers to quit. The investigators aim to test whether a mobile-based digital intervention designed with systematic input from low-income English- and Spanish-speaking smokers from a public sector health care system can significantly improve its acceptability, utilization, and effectiveness. Using human-centered development methods, the project will involve low-income patients of the San Francisco Health Network in the design of a web app/text messaging tool. The investigators will also use participants input to improve the recruitment and dissemination strategies. i4Health will join forces with the Center for Behavioral Intervention Technologies (CBITs) at Northwestern University to iteratively develop successive versions of the digital interventions informed by our human-centered approach. The full study involves 4 successive outcome studies testing the effectiveness of the Stop Smoking San Francisco web app. The first three are single-group non-randomized pre-post studies with 1, 2, and 3-month follow-ups. These will test gradually improved versions of the app. The fourth study will involve a randomized trial comparing the initial version (the baseline version) of the web app to the final version of the web app, to determine if the final version is significantly better than the baseline version in terms of increased utilization and abstinence rates. To join this study, go to: https://stopsmokingsf.org

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 15, 2018

Detailed Description

The project involves three specific aims: Specific Aim #1: Human-centered development of an English/Spanish smoking cessation web app. The investigators will develop iterative versions of a digital smoking cessation tool (a web app with text messaging components) that is highly responsive to the needs and preferences of low-income English- and Spanish-speaking smokers. Development will take place with systematic input from patients who are part of the San Francisco Health Network (SFHN). The SFHN serves 70,000 members, most of whom are low-income individuals. Specific Aim #2: Improvement of dissemination strategies. Input from SFHN patients will identify effective ways of reaching and encouraging low-income English- and Spanish-speaking smokers to use the digital smoking cessation interventions to be developed. This information will support ongoing dissemination and implementation efforts beyond the grant period. Specific Aim #3: Evaluation of resulting smoking cessation web app. Researchers will evaluate the effectiveness of the successive versions of the resulting stop smoking web app by recruiting smokers at two levels: a) within the SFHN, and b) throughout the state of California, culminating with an online randomized controlled trial. Increased effectiveness will be defined as 1) increased utilization of the web app and 2) higher abstinence rates than those obtained by a baseline "usual care" web app.

Interventions

  • Behavioral: Stop Smoking SF Web App – baseline
    • Smoking cessation web app in Spanish and English. Accessible online at no charge.

Arms, Groups and Cohorts

  • Experimental: Stop Smoking SF Web App – baseline
    • Online Study 1 will test the data gathering aspects of the proposed web app using a baseline, “usual care” intervention consisting of a static smoking cessation guide, the Guía para Dejar de Fumar, tested in printed form in the Muñoz et al. (1997) study. The print version of the guide yielded an 11% quit rate at 3 months. The investigators will utilize the content of the guide as the main element of the baseline app, so it will serve to estimate baseline utilization and quit rates when this already tested intervention is provided in a web app format. Participants can join the study online by going to: https://stopsmokingsf.org

Clinical Trial Outcome Measures

Primary Measures

  • 7-day Quit rate
    • Time Frame: 1 Month

Secondary Measures

  • Utilization of web app: Number of times web app screens are accessed and data entered
    • Time Frame: 1 month
    • Number of times web app screens are accessed and data entered

Participating in This Clinical Trial

Inclusion Criteria

  • English speaking (ES) and Spanish speaking (SS) Exclusion Criteria:

  • Not a smoker

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • i4Health
  • Collaborator
    • Center for Behavioral Intervention Technologies
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ricardo F. Munoz, Ph.D., Principal Investigator, Director, i4Health, Palo Alto University

References

Munoz RF, Marin BV, Posner SF, Perez-Stable EJ. Mood management mail intervention increases abstinence rates for Spanish-speaking Latino smokers. Am J Community Psychol. 1997 Jun;25(3):325-43. doi: 10.1023/a:1024676626955.

Muñoz, R. F., Bunge, E. L., Chen, K., Schueller, S. M., Bravin, J. I., Shaughnessy, E. A., & Pérez-Stable, E. J. (2015). Massive Open Online Interventions: A novel model for delivering behavioral-health services worldwide. Clinical Psychological Science. Advance online publication. doi: 10.1177/2167702615583840

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.