Using Technology to Help Low-income and Latino Smokers Quit

Smoking Cessation Clinical Trial

Official title:

Using Technology to Help Low-income and Latino Smokers Quit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02666482
• Other study ID #: 24RT-0027
• Status: Completed
• Phase: N/A
• Start date: January 12, 2016
• Est. completion date: June 15, 2018

Study information

• Verified date: November 2018
• Source: i4Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1107
• Est. completion date: June 15, 2018
• Est. primary completion date: June 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• English speaking (ES) and Spanish speaking (SS)

Exclusion Criteria:

• Not a smoker

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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

Locations

Country	Name	City	State
United States	Palo Alto University	Palo Alto	California

Sponsors (3)

Lead Sponsor	Collaborator
i4Health	Center for Behavioral Intervention Technologies, San Francisco Health Network

Country where clinical trial is conducted

United States, 

References & Publications (2)

Muñoz RF, Marín BV, Posner SF, Pérez-Stable EJ. Mood management mail intervention increases abstinence rates for Spanish-speaking Latino smokers. Am J Community Psychol. 1997 Jun;25(3):325-43. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-day Quit rate		1 Month
Secondary	Utilization of web app: Number of times web app screens are accessed and data entered	Number of times web app screens are accessed and data entered	1 month