Veteran Social Support for Enhancing Use of Smoking Cessation Treatment
NCT ID: NCT05868421
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
2376 participants
INTERVENTIONAL
2024-02-01
2028-02-01
Brief Summary
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Detailed Description
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Specific Aims. Aim 1: To evaluate the impact of the social support intervention on Veteran smokers' use of EBCT. Aim 2: To examine the effectiveness of the social support intervention on the biochemically confirmed 7-day point prevalence cigarette smoking abstinence. Aim 3: To explore potential moderators (e.g., smoker gender, SP tobacco use status) of intervention effects on study outcomes. Aim 4: To conduct a process evaluation assessing implementation outcomes (reach, adoption, fidelity) of the social support intervention and multilevel factors that may influence implementation.
Methods: The investigators will conduct a pragmatic randomized controlled trial (RCT) within the national VHA health system to evaluate the effectiveness of a social support intervention compared with a control condition on utilization of EBCT among VHA-enrolled smokers. Veteran smokers, regardless of level of readiness to quit, will be identified nationally using the VHA electronic health record and proactively recruited. Interested smokers will be asked to identify a support person (SP) who will enroll. Participants will be randomized as smoker-SP dyads to the intervention (n= 594 dyads) or control condition (n= 594 dyads). All smokers will receive written resources and information on EBCTs. 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, 3-, and 6-months post-randomization.
Innovation and Impact: This 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, the 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. It is expected to be especially beneficial for Veteran smokers who might not otherwise access cessation treatment. Because the prior VHA trials enrolled about 94% men and the higher smoking rates among women, the investigators will oversample women to enroll an equal number of men and women smokers. This study contributes to VA HSR\&D's priority initiatives for enhancing treatment access and women's health and is significant because it will advance research on the role of partnering with Veterans' families and/or important others to enhance access to VA healthcare and population-specific treatments, especially women Veterans. The potential reach and public health impact of an effective social support intervention for the Veteran tobacco user population is considerable.
Implementation/Next Steps: Next steps depend on the actual results, but the investigators expect findings to be important to VA leaders, the VA Women's Health Research Consortium and the Veteran community. The investigators will maintain communication throughout the project with VA program partners to share findings in a timely manner. The investigators will collaborate with CCDOR's Veteran Engagement Panel on development of patient-centered dissemination approaches and recommendations for future intervention adaptations and/or implementation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Support Person Coaching Call and Written Materials
Support persons will receive written material resources on support strategies to stop smoking, and resources on how to stop smoking. Support person participants assigned to the intervention group will additionally receive a 1-call coaching session about 15-25 minutes in duration on how to support their Veteran smoker. The coaching session will be delivered by research staff by phone or video call. Veteran smokers will receive written smoking cessation resource and referral information for VHA and non-VHA EBCT options.
Support Person Coaching Call
Support person participants assigned to the intervention group will additionally receive a 1-call coaching session about 15-25 minutes in duration on how to support their Veteran smoker. The session will be delivered by research staff by phone or video call. Support persons in the intervention group and the control/no intervention group will receive existing written material resources on support strategies to stop smoking, and resources on how to stop smoking by postal mail or email.
SP written materials
Written materials covering tips on effective supportive strategies for smoking cessation
Written Smoking Cessation Materials
Written materials on resource and referral information for VHA and non-VHA EBCT options
Written Materials Only
Support persons will receive written material resources on support strategies to stop smoking, and resources on how to stop smoking. Veteran smokers will receive written smoking cessation resource and referral information for VHA and non-VHA EBCT options.
SP written materials
Written materials covering tips on effective supportive strategies for smoking cessation
Written Smoking Cessation Materials
Written materials on resource and referral information for VHA and non-VHA EBCT options
Interventions
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Support Person Coaching Call
Support person participants assigned to the intervention group will additionally receive a 1-call coaching session about 15-25 minutes in duration on how to support their Veteran smoker. The session will be delivered by research staff by phone or video call. Support persons in the intervention group and the control/no intervention group will receive existing written material resources on support strategies to stop smoking, and resources on how to stop smoking by postal mail or email.
SP written materials
Written materials covering tips on effective supportive strategies for smoking cessation
Written Smoking Cessation Materials
Written materials on resource and referral information for VHA and non-VHA EBCT options
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* If using other tobacco or nicotine products, cigarettes are the main product used
* Willing to support the Veteran smoker
* Have to have access to any type of phone (or tablet for video call) for delivery of the SP intervention
Exclusion Criteria
* Have no valid phone contact information
18 Years
ALL
Yes
Sponsors
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VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Steven S. Fu, MD MSCE
Role: PRINCIPAL_INVESTIGATOR
Minneapolis VA Health Care System, Minneapolis, MN
Locations
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Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IIR 20-117
Identifier Type: -
Identifier Source: org_study_id
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