Using Technology to Help Low-income and Latino Smokers Quit

November 13, 2018 updated by: i4Health

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1107

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Palo Alto University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 97 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Not a smoker

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Behavioral: Stop Smoking SF Web App - baseline
Smoking cessation web app in Spanish and English. Accessible online at no charge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
7-day Quit rate
Time Frame: 1 Month
1 Month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

i4Health

Collaborators

Center for Behavioral Intervention Technologies
San Francisco Health Network

Investigators

  • Principal Investigator: Ricardo F. Munoz, Ph.D., Director, i4Health, Palo Alto University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2016

Primary Completion (Actual)

June 15, 2018

Study Completion (Actual)

June 15, 2018

Study Registration Dates

First Submitted

January 21, 2016

First Submitted That Met QC Criteria

January 27, 2016

First Posted (Estimate)

January 28, 2016

Study Record Updates

Last Update Posted (Actual)

November 15, 2018

Last Update Submitted That Met QC Criteria

November 13, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 24RT-0027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Smoking Cessation

Clinical Trials on Stop Smoking SF Web App - baseline

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe