- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04311983
Interventions to Help More Low-income Smokers Quit (SFH)
November 7, 2023 updated by: Washington University School of Medicine
Expanding Population-level Interventions to Help More Low-income Smokers Quit
In a Hybrid Type 2 randomized trial, 1,980 low-income smokers from nine states with high smoking prevalence will be recruited from 2-1-1 helplines to receive either current standard practice (Quitline) or expanded services (Quitline + Smoke Free Homes) to increase tobacco cessation.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
There is an urgent need to engage more low-income smokers in activities that lead to quitting.
The current standard of practice for population-level tobacco treatment is phone-based cessation counseling delivered by state tobacco quitlines.
But quitline services are restricted to smokers who are ready to quit in the next 30 days, a criterion met by only 20-30% of low-income smokers.
Thus, current population level tobacco treatment has nothing to offer 70-80% of low-income U.S. smokers.
Based on extensive preliminary research by our study team, the investigators assert that offering a pre-cessation intervention - Smoke Free Homes - to low-income smokers who are not yet ready to quit will: (1) engage more smokers in using proven interventions; (2) increase their readiness to quit and quit attempts; (3) reduce the number of cigarettes they smoke per day; and (4) increase cessation.
These benefits will accrue in addition to reducing exposure to harmful secondhand smoke for non-smokers in the home.
In a Hybrid Type 2 randomized trial, 1,980 low-income smokers from nine states with high smoking prevalence will be recruited from 2-1-1 helplines to receive either current standard practice (Quitline) or expanded services (Quitline + Smoke Free Homes).
In the latter condition, smokers will be offered cessation counseling first, just like current standard practice, but those who decline will then be offered Smoke Free Homes.
At 3-month followup, those in the latter condition who accepted quitline services but did not quit will be offered Smoke Free Homes, and those that accepted Smoke Free Homes but did not quit will be offered quitline services.
The effectiveness portion of the Hybrid Type 2 design (Aim 1) will use intent-to-treat analyses to compare group differences at 3- and 6-month follow-up in 7- and 30-day point prevalence abstinence with biochemical verification, as well as 24-hour quit attempts and cigarettes smoked per day.
The implementation portion of the Hybrid Type 2 design (Aims 2-3) will measure smokers' acceptance and use of the interventions, as well as cost-effectiveness and cost-benefits of adding Smoke Free Homes to quitline services.
With rates of smoking and smoking-related cancers much higher in low-income populations and treatment costs exceeding tens of billions of dollars annually in Medicaid alone, this large-scale practical trial will provide strong evidence with high external validity to answer an important policy question: Will changing the standard practice for population-level treatment of smoking result in increased cessation in low-income populations?
Study Type
Interventional
Enrollment (Actual)
1982
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 Contact
- Name: Matthew Kreuter, Ph.D.
- Phone Number: 314-935-3701
- Email: mkreuter@wustl.edu
Study Contact Backup
- Name: Amy McQueen, PhD
- Phone Number: 314-935-3715
- Email: amcqueen@wustl.edu
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
-
-
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
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Age ≥21
- English-speaking
- Daily smoker
- Does not have a full home smoking ban
- Recruited from those who called 2-1-1 for themselves and are not in acute crisis
Exclusion Criteria:
-Pregnant women, because recommended tobacco cessation actions differ for this subset of smokers
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Tobacco Quitline only
Smokers in this study group will be offered their state Tobacco Quitline programs
|
Tobacco quitlines provide phone counseling from a quit coach, often supplemented with NRT (nicotine replacement therapy), a quit guide, text messages, or other support.
Smokers can call directly or consent to be called by the quitline ("fax-back").
|
Experimental: Tobacco Quitline plus Smoke Free Homes
Smokers in this study group will be offered their state Tobacco Quitline programs, but if they decline, they will be offered a Smoke Free Homes intervention
|
Tobacco quitlines provide phone counseling from a quit coach, often supplemented with NRT (nicotine replacement therapy), a quit guide, text messages, or other support.
Smokers can call directly or consent to be called by the quitline ("fax-back").
The intervention guides participants though a 5-step process: (1) deciding to create a smoke-free home; (2) talking about it with household members; (3) setting a date for the home to become smoke-free; (4) making the home smoke-free; and (5) keeping the home smoke-free.
Progress from one step to the next is facilitated over a 6-week period by three mailings sent to participants' homes and one telephone counseling call delivered by a trained smoke free homes coach.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
7day point prevalence for smoking
Time Frame: 6 month follow-up
|
Proportion of participants who have 7 day smoking abstinence
|
6 month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of participants who accept the tobacco quitline program
Time Frame: Baseline and 3-month follow-up
|
|
Baseline and 3-month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Matthew Kreuter, Ph.D., Washington University School of Medicine
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.
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)
March 31, 2020
Primary Completion (Actual)
September 29, 2023
Study Completion (Actual)
September 29, 2023
Study Registration Dates
First Submitted
March 10, 2020
First Submitted That Met QC Criteria
March 16, 2020
First Posted (Actual)
March 17, 2020
Study Record Updates
Last Update Posted (Estimated)
November 8, 2023
Last Update Submitted That Met QC Criteria
November 7, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 202002125-1001
- 1R01CA235773-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The HCRL Data Center will make the datasets and other materials available without cost to researchers and analysts after a data sharing agreement is completed.
Consistent with NIH guidelines, the data sharing agreement: (1) records a request for data use and detailed description of the intent of use; (2) details the study's publication guidelines, including acknowledging and citing project personnel as appropriate; (3) ensures IRB compliance, including not using these data for non-research purposes; and (4) stipulates that users will not share or distribute the data to others without written permission.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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