NCT05868421

Brief Summary

This study is recruiting Veterans who currently smoke cigarettes and support persons who are nominated by the Veterans. The purpose of this study is to assist Veterans with smoking cessation by asking Veterans to choose a support person who will assist them with the quitting process, or who may assist them with the quitting process once the Veteran is ready to quit smoking sometime in the future. Study staff will assess how much or how little social support during the Veteran's quitting process is helpful to the Veteran. This information will help us come up with new ways to help Veterans quit smoking that are better tailored to their needs.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,376

participants targeted

Target at P75+ for not_applicable

Timeline
21mo left

Started Feb 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress58%
Feb 2024Feb 2028

First Submitted

Initial submission to the registry

May 5, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 22, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

3 years

First QC Date

May 5, 2023

Last Update Submit

January 14, 2026

Conditions

Smoking CessationVeterans Health

Keywords

Smoking cessationSocial supportVeterans healthTobacco cessationSupport persons

Outcome Measures

Primary Outcomes (1)

  • Use of Any Evidence-Based Cessation Treatments (EBCTs)

    The primary outcome will be use of any EBCT assessed at the 6 month follow-up: medication, behavioral intervention, or combination using both self-report and VHA administrative data. Data will be extracted from the VA Corporate Data Warehouse (CDW) to assess VA treatment use. VA outpatient prescription records will be used to assess receipt and amount of pharmacotherapy (bupropion, varenicline, nicotine replacement therapy (NRT)) and VA outpatient encounters associated with smoking cessation will be assed using stop codes (i.e., 707 and 708) and/or diagnoses treated for nicotine dependence (i.e., ICD10-F17.XX) to assess behavioral interventions. Use of QuitVET, SmokefreeVET, Department of Defense (DoD) and non-VHA treatment use will be assessed using self-report.

    6 months

Secondary Outcomes (5)

  • Biochemically confirmed 7-day point prevalence cigarette smoking abstinence

    6 months

  • Use of Any Evidence-Based Cessation Treatments (EBCTs)

    3 months

  • Self-reported 7-day point prevalence cigarette smoking abstinence

    6 months

  • Self-reported 7-day point prevalence cigarette smoking abstinence

    3 months

  • Prolonged smoking abstinence

    6 months

Study Arms (2)

Support Person Coaching Call and Written Materials

EXPERIMENTAL

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.

Behavioral: Support Person Coaching CallBehavioral: SP written materialsBehavioral: Written Smoking Cessation Materials

Written Materials Only

ACTIVE COMPARATOR

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.

Behavioral: SP written materialsBehavioral: Written Smoking Cessation Materials

Interventions

Support Person Coaching CallBEHAVIORAL

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.

Also known as: SP Coaching Call Intervention
Support Person Coaching Call and Written Materials
SP written materialsBEHAVIORAL

Written materials covering tips on effective supportive strategies for smoking cessation

Also known as: Written support person strategies
Support Person Coaching Call and Written MaterialsWritten Materials Only
Written Smoking Cessation MaterialsBEHAVIORAL

Written materials on resource and referral information for VHA and non-VHA EBCT options

Support Person Coaching Call and Written MaterialsWritten Materials Only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Smoked 1 cigarettes over the past 30 days, even a puff
  • 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

You may not qualify if:

  • Have used cessation medications or a stop smoking program within the past 3 months
  • Have no valid phone contact information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417-2309, United States

RECRUITING

MeSH Terms

Conditions

Smoking CessationTobacco Use Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Steven S. Fu, MD MSCE

    Minneapolis VA Health Care System, Minneapolis, MN

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alicia B Woodward-Abel

CONTACT

(612) 467-1229alicia.woodward-abel@va.gov

Sarah Becker

CONTACT

(612) 467-1515Sarah.Becker4@va.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcomes assessors are blinded to intervention group assignment.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: pragmatic randomized controlled trial that will randomize Smoker-Support Person dyads with 1:1 allocation
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2023

First Posted

May 22, 2023

Study Start

February 1, 2024

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2028

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Final datasets underlying all publications will not be shared outside the VA, except as required under the Freedom of Information Act (FOIA). Analytic datasets will be housed on VINCI data servers. Outside investigators can follow VA procedures and receive training and approval for access within VA firewalls.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Per VA policy
Access Criteria
Per VA procedure

Locations

US(1)