Health TrialsbyHealthPanel

Veteran Social Support for Enhancing Use of Smoking Cessation Treatment

ConditionsSmoking CessationVeterans Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

If using other tobacco or nicotine products, cigarettes are the main product used

Able to identify one adult family member or friend (SP) with whom they have contact (of any form) at least 3 times per week who will enroll Veteran Support Person Inclusion Criteria

Willing to support the Veteran smoker

Disqualifiers

Have used cessation medications or a stop smoking program within the past 3 months

Have no valid phone contact information

Trial design

Design model

Parallel

Treatments tested in this trial

  • Support Person Coaching Call

    Behavioral

    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

    Behavioral

    Written materials covering tips on effective supportive strategies for smoking cessation

  • Written Smoking Cessation Materials

    Behavioral

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

Treatment groups

2,376 Participants
are divided into 2 treatment groups
Group A: Support Person Coaching Call and Written MaterialsExperimental treatment 3 interventions
Group B: Written Materials OnlyActive comparator 2 interventions

Trial outcomes

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.

Time frame
6 months

Secondary outcomes

1

Biochemically confirmed 7-day point prevalence cigarette smoking abstinence

For this trial, the focus with respect to abstinence is on combustible cigarette smoking. The investigators will assess self-reported 7-day point-prevalence abstinence 6-months and obtain biochemical verification at 6 months, defined as a negative carbon monoxide (CO) breath test (0-6 ppm) or negative salivary cotinine (\< 30 ng/ml). Biochemical verification will be obtained using expired CO by mailing an iCO Smokerlyzer®, a small, portable, handheld breath CO monitor that connects to a mobile device or tablet, as the primary modality because carbon monoxide is not confounded by use of NRT, smokeless tobacco or e-cigarettes.

Time frame
6 months
2

Use of Any Evidence-Based Cessation Treatments (EBCTs)

use of any EBCT: medication, behavioral intervention, or combination using both self-report and VHA administrative data

Time frame
3 months
3

Self-reported 7-day point prevalence cigarette smoking abstinence

Any cigarette smoking in the past 7 days, even a puff

Time frame
6 months
4

Self-reported 7-day point prevalence cigarette smoking abstinence

Any cigarette smoking in the past 7 days, even a puff

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Office of Research and Development

Lead sponsor

Source ClinicalTrials.gov
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