Smoking Cessation Clinical Trial
— VAntagePilotOfficial title:
Veteran Social Support Intervention for Enhancing Smoking Treatment Utilization and Cessation Pilot Project
This is a proposal to conduct a pilot study to assess the feasibility of recruitment of Veteran smoker and support person (SP) dyads and study procedures in preparation for a large randomized pragmatic trial.
Status | Recruiting |
Enrollment | 64 |
Est. completion date | December 1, 2024 |
Est. primary completion date | September 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Veteran: Veteran has to be current tobacco user (past month) and and has smoked greater than 1 cigarette in the past 30 days, aged 18 years or older, cigarettes are the main tobacco product being used, are able to identify a support person to volunteer in the study with them who they have contact with (of any form) at least 3 times per week, and the Veteran has to have access to a smartphone or tablet device. - Support Person: Has to be 18 years or older, willing to participate in the study and support the Veteran smoker, and have access to any type of phone they are able to complete the screener and coaching intervention call with. Exclusion Criteria: - Veteran: Does not use cigarettes as may tobacco use, does not smoke, is younger than 18 years of age, does not have a support person to have participate with them in the study, does not have access to a smartphone or tablet device. - Support Person: Does not have access to a phone, is not willing to support the Veteran and participate in the study, or is younger than 18 years of age. |
Country | Name | City | State |
---|---|---|---|
United States | Minneapolis Veterans Administration Health Care System | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Minneapolis Veterans Affairs Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recruitment Feasibility | We will keep detailed recruitment records to track several variables to characterize the reach of the intervention, including the percent of smokers in our recruitment pool who are reached by mail/phone for an enrollment offer; the percent of reached smokers who are eligible for the intervention based on mail/phone screening; and reasons for ineligibility (e.g., cannot identify an SP). We will also track the percent of reach smokers who identify a SP and the proportion of SPs who are eligible. We will also use recruitment records to calculate intervention adoption, defined as the percent of Veterans and SPs who enroll, as well as the percent of women Veterans enrolled. We will track reasons for enrollment refusal among both smokers and SPs. | Duration of project, one year | |
Secondary | Smoking abstinence: feasibility of biochemical confirmation using a remote collection method | Our cessation outcomes follow recent recommendations from an SRNT workgroup that updated definitions and measurement of abstinence in clinical trials of smoking cessation interventions. Self-report of cigarette smoking for the past 7 days, even a puff, will be obtained at one-month follow-up. We will obtain biochemical verification of self-reported smoking abstinence using expired air carbon monoxide (CO). Upon reporting 7-day abstinence, smoker participants will receive by mail the iCO™ Smokerlyzer®, a small, portable, handheld breath CO monitor that connects to a mobile device or tablet. Mobile-phone based CO monitoring and the iCO™ (Bedfont® Scientific Ltd) has been field tested and validated with the traditional Smokerlyzer® Bedfont CO detector. | One-month after randomization |
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