Connection to Health for Smokers

Not Applicable

Completed

• Conditions: Tobacco Use
• Interventions: Behavioral: Enhanced Standard of Care; Behavioral: Connection to Health for Smokers

• Registration Number: NCT03680599
• Lead Sponsor: University of California, San Francisco

Brief Summary

The goal of the study is to develop and test Connection to Health for Smokers (CTHS), a comprehensive program to support smokers to quit and improve smokers' general health. The program will be designed for implementation by health educators in community health centers.

Detailed Description

The investigators will use a participatory approach to develop and test the feasibility and acceptability of CTHS in community health center sites in Contra Costa County. Development of the program will be informed by active engagement with a patient advisory group composed of current smokers and clinical team members who serve current smokers in community health centers. Feasibility and acceptability will be assessed by implementing the CTHS program for patients in 3 clinical sites, using the RE-AIM evaluation framework. Primary outcomes will include the number and proportion of enrolled smokers who create at least one health-related action plan with a health educator, and stated intention of clinical teams to continue using CTHS after the research. The investigators will enroll 90 smokers in CTHS and 90 additional smokers in Enhanced Standard of Care (ESC) which will be the active comparison group. Participants will be randomly assigned. Smoking status will be reassessed after 3 months. Primary outcomes will include number of 24-hour quit attempts, and 7-day smoking abstinence, as well as changes in self-efficacy and readiness to quit smoking among participants who do not quit. Results of this pilot program will inform further development of the CTHS program for testing in larger scale clinical trials.

Study Timeline

• Study First Submitted: 2018-09-19
• Study First Submitted QC: 2018-09-19
• Study First Posted: 2018-09-21
• Study Start: 2019-01-03
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-30
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31
• Last Update Posted: 2020-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

• Must have smoked cigarettes in the last 7 days

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Exclusion Criteria

• Speaking languages other than English or Spanish

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced Standard of Care	Enhanced Standard of Care	Participants in this arm will participate in Enhanced Standard Care, wherein participants will receive a brief electronic survey and receive standard smoking cessation program that does not include formal action planning and multimodal follow up.
Connection to Health for Smokers	Connection to Health for Smokers	Participants in this arm will participate in the Connection to Health for Smokers Arm of the study, wherein an electronic survey will be administered and participants will be guided through an evidence-based action planning sequence, taking into account each patient's unique social environment, health related behaviors, and behavioral health status, with multimodal follow up.

Primary Outcome Measures

Name	Time	Method
Program Reach, Effectiveness, Adoption, Implementation, and Maintenance	3 months	The RE-AIM Framework will be used to assess program feasibility

Secondary Outcome Measures

Name	Time	Method
7-day smoking abstinence	3 months	Not smoking cigarettes (not even a puff) in the last 7 days

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States