Connection to Health for Smokers

Tobacco Use Clinical Trial

— CTHS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03680599
• Other study ID #: 27IP-0024
• Status: Completed
• Phase: N/A
• Start date: January 3, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: March 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must have smoked cigarettes in the last 7 days

Exclusion Criteria:

• Speaking languages other than English or Spanish

Related Conditions & MeSH terms

• Tobacco Use

Intervention

Behavioral:
• Connection to Health for Smokers
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
Participants will complete a survey and receive standard one-on-one smoking cessation according to a usual care protocol delivered by health educators

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Program Reach, Effectiveness, Adoption, Implementation, and Maintenance	The RE-AIM Framework will be used to assess program feasibility	3 months
Secondary	7-day smoking abstinence	Not smoking cigarettes (not even a puff) in the last 7 days	3 months