Smoking CessationVAntagePilotNCT04840108
Veteran Support for Smoking Cessation Pilot Project (VAntage Pilot)
A study testing Support Person Coaching Intervention and Support Person Written Materials in people with Smoking Cessation, run by Minneapolis Veterans Affairs Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Support Person Coaching Intervention and Support Person Written Materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2021to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Minneapolis Veterans Administration Health Care System
Minneapolis, Minnesota, 55417
Mariah C Branson, BA, 612-467-4920 ext. 314920, mariah.branson@va.gov
Steven S Fu, MD, MSCE, (612) 467-2582 ext. 312582, steven.fu@va.gov
About this study
Official 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.
Read the detailed description
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. Enhancing access and use of evidence-based tobacco cessation treatments and eliminating tobacco-related health disparities are top national and VA health services priorities. The prevalence of tobacco use is greater among Veterans compared to non-Veterans. From 2010-2015, 28.9% of women and 21.1% of male Veterans reported current cigarette smoking. Because our prior VHA trials enrolled about 94% men and the higher smoking rates among women, we will examine the feasibility of recruitment of an equal number of men and women Veteran smokers in this pilot study. Evidence-based cessation treatments (EBCTs) such as, tobacco quitlines, behavioral counseling, and pharmacotherapy, are greatly underutilized by Veteran smokers. This pilot project is innovative for evaluating social support networks as a proactive outreach approach to enhance cessation treatment utilization among Veteran smokers. The role of social network influences and social support on successful smoking cessation is established. Based on Cohen's theory of social support, our team developed a social support intervention for diverse family members, friends, and other adults who wanted to help a smoker quit. The intervention consists of written materials and a 1-call, 15-25 minute coaching session. The intervention goal is for support persons (SPs) to encourage their smoker to use EBCT.
We will conduct a randomized pilot trial within the national VHA health system to evaluate the feasibility of recruitment of smoker-SP dyads and other study procedures. Veteran smokers, regardless of level of readiness to quit, will be identified nationally using the VHA electronic health record (EHR) data base and proactively recruited. Interested smokers will be asked to identify a SP who will enroll. Participants will be randomized as smoker-SP dyads to the intervention (n= 15 dyads) or control condition (n= 15 dyads). All smoker participants will receive written resources and information on evidence-based cessation treatments. All SP participants will receive written materials. SP participants assigned to the intervention group will additionally receive a 1-call coaching session. Assessments for dyads in both study groups will be conducted at baseline and at 3-months post-randomization.
Our specific aims are to: (Aim 1) To assess the feasibility of recruitment of 30 Veteran smoker-SP dyads including enrollment of an equal number of men and women Veterans; and (Aim 2) To evaluate the feasibility of biochemical verification of the smoker's abstinence at 1-month follow-up using a remote collection method.
If the project is successful, we will have a blueprint for conducting a large randomized pragmatic trial. Preliminary data will be incorporated in a grant resubmission to the VA HSR\& D to support the feasibility of recruitment and other study procedures.
- Conditions
- Smoking Cessation
- Being tested
- Support Person Coaching Intervention, Support Person Written Materials
- Keywords
- Smoking cessation, Support Person
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Support Person Coaching InterventionBehavioural
The intervention condition will include, for the SPs, a manualized, 1-session coaching intervention delivered by a research coach. The call will be delivered by phone using VA-permitted remote audio or video communication technology (e.g., doximity dialer, Zoom, or VA Video Connect if a Veteran). Coaches will use behavior change strategies delivered with a MI style.
Support Person Written MaterialsBehavioural
Support persons will receive existing written materials on effective social support strategies for smoking cessation. Materials will be sent via postal mail.
| Study group | Role | What they receive |
|---|---|---|
| Support Person Coaching Intervention | Experimental | Support persons in the intervention arm will receive existing written materials on effective social support strategies for smoking cessation. Materials will be sent via postal mail. Support persons in this arm will also complete a one-session coaching intervention (15-25 minutes) delivered virtually by research staff via phone. Receives: Behavioral: Support Person Coaching Intervention; Behavioral: Support Person Written Materials |
| Support Person Written Materials | Active comparator | Support persons in the intervention arm will receive existing written materials on effective social support strategies for smoking cessation. Materials will be sent via postal mail. Receives: Behavioral: Support Person Written Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Duration of project, one year
Secondary outcomes (1)
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.
Measured: One-month after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start12 Apr 2021
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minneapolis Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Steven S. Fu, Minneapolis Veterans Affairs Medical Center
- Investigators
- Steven Fu, MD, MSCE, Principal investigator, MinnepolisVAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840108
- Sponsor's protocol ID
- VAM-20-00576
- Acronym
- VAntagePilot
- Status last verified
- Nov 2023
- First submitted
- 7 Apr 2021
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Veteran Social Support Intervention for Enhancing Smoking Treatment Utilization and Cessation Pilot Project
- ClinicalTrials.gov ID
- NCT04840108
- Acronym / sponsor ID
- VAntagePilot / VAM-20-00576
- Conditions
- Smoking Cessation
- Keywords
- Smoking cessation, Support Person
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Minneapolis Veterans Affairs Medical CenterUS federal agency
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 9 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. Enhancing access and use of evidence-based tobacco cessation treatments and eliminating tobacco-related health disparities are top national and VA health services priorities. The prevalence of tobacco use is greater among Veterans compared to non-Veterans. From 2010-2015, 28.9% of women and 21.1% of male Veterans reported current cigarette smoking. Because our prior VHA trials enrolled about 94% men and the higher smoking rates among women, we will examine the feasibility of recruitment of an equal number of men and women Veteran smokers in this pilot study. Evidence-based cessation treatments (EBCTs) such as, tobacco quitlines, behavioral counseling, and pharmacotherapy, are greatly underutilized by Veteran smokers. This pilot project is innovative for evaluating social support networks as a proactive outreach approach to enhance cessation treatment utilization among Veteran smokers. The role of social network influences and social support on successful smoking cessation is established. Based on Cohen's theory of social support, our team developed a social support intervention for diverse family members, friends, and other adults who wanted to help a smoker quit. The intervention consists of written materials and a 1-call, 15-25 minute coaching session. The intervention goal is for support persons (SPs) to encourage their smoker to use EBCT.
We will conduct a randomized pilot trial within the national VHA health system to evaluate the feasibility of recruitment of smoker-SP dyads and other study procedures. Veteran smokers, regardless of level of readiness to quit, will be identified nationally using the VHA electronic health record (EHR) data base and proactively recruited. Interested smokers will be asked to identify a SP who will enroll. Participants will be randomized as smoker-SP dyads to the intervention (n= 15 dyads) or control condition (n= 15 dyads). All smoker participants will receive written resources and information on evidence-based cessation treatments. All SP participants will receive written materials. SP participants assigned to the intervention group will additionally receive a 1-call coaching session. Assessments for dyads in both study groups will be conducted at baseline and at 3-months post-randomization.
Our specific aims are to: (Aim 1) To assess the feasibility of recruitment of 30 Veteran smoker-SP dyads including enrollment of an equal number of men and women Veterans; and (Aim 2) To evaluate the feasibility of biochemical verification of the smoker's abstinence at 1-month follow-up using a remote collection method.
If the project is successful, we will have a blueprint for conducting a large randomized pragmatic trial. Preliminary data will be incorporated in a grant resubmission to the VA HSR\& D to support the feasibility of recruitment and other study procedures.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Support Person Coaching Intervention | Experimental | Behavioral: Support Person Coaching Intervention, Behavioral: Support Person Written MaterialsSupport persons in the intervention arm will receive existing written materials on effective social support strategies for smoking cessation. Materials will be sent via postal mail. Support persons in this arm will also complete a one-session coaching intervention (15-25 minutes) delivered virtually by research staff via phone. |
| Support Person Written Materials | Active comparator | Behavioral: Support Person Written MaterialsSupport persons in the intervention arm will receive existing written materials on effective social support strategies for smoking cessation. Materials will be sent via postal mail. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Support Person Coaching InterventionThe intervention condition will include, for the SPs, a manualized, 1-session coaching intervention delivered by a research coach. The call will be delivered by phone using VA-permitted remote audio or video communication technology (e.g., doximity dialer, Zoom, or VA Video Connect if a Veteran). Coaches will use behavior change strategies delivered with a MI style. | Behavioural | Support Person Coaching Intervention |
| Support Person Written MaterialsSupport persons will receive existing written materials on effective social support strategies for smoking cessation. Materials will be sent via postal mail. | Behavioural | Support Person Coaching Intervention, Support Person Written Materials |
Primary outcome
Recruitment Feasibility
Time frame: Duration of project, one year
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.
1 secondary outcome
Smoking abstinence: feasibility of biochemical confirmation using a remote collection method
Time frame: One-month after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Smoking Cessation
Active, not recruiting
An Interactive Smartphone Application to Motivate Smokers to Quit
Smoking Cessation, Smoking Behaviors
Not yet recruiting
Comparing the Efficacy of a Conversational Agent (QuitBot) Versus Standard Health Education on Smoking Cessation Among Medical Students; A Randomized Controlled Trial.
Conversational Agent, Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Active, not recruitingPhase 3
Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
Tobacco Dependence
Active, not recruitingEarly Phase 1
Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung Cancer
Smoking Cessation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Fu, MD, MSCE principal investigator
MinnepolisVAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Support Person Coaching Intervention and Support Person Written Materials in people with Smoking Cessation, run by Minneapolis Veterans Affairs Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariah C Branson, BA ((612) 467-4920 ext. 314920, mariah.branson@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Feasibility (time frame: Duration of project, one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.