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Intervention to Increase Intention to Change Alcohol/Tobacco Use in Veterans With Chronic Disease

NCT07039175 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2025-12-31

No results posted yet for this study

Summary

Many Veterans who have chronic conditions like cardiovascular disease or diabetes smoke or drink too much alcohol, which can worsen the condition. Veterans are asked yearly about drinking/smoking and providers provide a brief advice discussion focused on behavior change. However, many Veterans continue to drink or smoke, and are often not interested in higher-intensity, change-based referrals. The investigators recently piloted MINDSET, an intervention that fills this gap. MINDSET is a proactive, population-based intervention that uses a mailed packet with tailored education about how drinking/smoking relate to the Veteran's condition (heart conditions and/or diabetes), followed by a brief motivational call. The investigators will test MINDSET's effectiveness versus usual primary care on outcomes including intention to change and substance use and evaluate the relationships between these and other variables over time.

Conditions

  • Tobacco Smoking
  • Alcohol-Related Disorders

Interventions

BEHAVIORAL

MINDSET

A behavior-change model informed mailed informational packet with tailored health information regarding the impacts of smoking/drinking on chronic disease and the benefits of stopping, followed by a brief motivational telephone booster call from a behavioral health provider.

OTHER

Usual Care

All Veterans involved in this study will have a standard primary care (PC) appointment, which may include conversations/interventions related to drinking and smoking. This appointment is not controlled by the study team and we cannot comment on the extent to which smoking/drinking will or will not be discussed in the primary care appointment but we imagine this can range from no discussion/intervention at all to extensive conversations with the provision of medications, brief advice, etc.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Julie Christina Gass, PhD · VA Western New York Healthcare System, Buffalo, NY

  • Jennifer S Funderburk, PhD · Syracuse VA Medical Center, Syracuse, NY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2028-12-31
Completion
2029-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07039175 on ClinicalTrials.gov