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Completed

NCT Number: NCT03680599

Connection to Health for Smokers

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.

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Key information

Conditions

Tobacco Use Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must have smoked cigarettes in the last 7 days

Exclusion criteria

  • Speaking languages other than English or Spanish

Treatment and study plan

Connection to Health for Smokers

Behavioral

Connection to Health for Smokers includes 5 core components supported by online tools: (1) comprehensive electronic patient survey, (2) automated summary report to flag areas of difficulty (3) interactive priority setting, (4) interactive action planning, and (5) electronic text reminders and followup.

Enhanced Standard of Care

Behavioral

Participants will complete a survey and receive standard one-on-one smoking cessation according to a usual care protocol delivered by health educators

Primary outcomes

  1. Program Reach, Effectiveness, Adoption, Implementation, and Maintenance

    Time frame: 3 months

    The RE-AIM Framework will be used to assess program feasibility

Secondary outcomes

  1. 7-day smoking abstinence

    Time frame: 3 months

    Not smoking cigarettes (not even a puff) in the last 7 days

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Connection to Health for Smokers -- A Comprehensive Program to Reduce Tobacco-Related Health Disparities in CHCs

Acronym: CTHS

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 21, 2018
Registry last updated
Apr 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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