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

Part of paid clinical trials in Buffalo, New York.

Sponsor
VA Office of Research and Development
Study ID
NCT07039175
Phase
PHASE3
Status
Recruiting
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Conditions

  • Alcohol-Related Disorders
  • Tobacco Smoking

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MINDSET — BEHAVIORAL
    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.
  • Usual Care — OTHER
    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.

Study Details

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.

Key Dates

Start date
Oct 1, 2025
Status verified
Dec 2025
Primary completion
Dec 31, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
270 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MINDSET+UC
    Within one month following a standard primary care appointment (which comprises usual care; UC), Veterans in this condition will receive the MINDSET intervention which consists of: 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.
  • Active Comparator: Usual Care
    All Veterans in this study will have a primary care appointment during which their primary care team will administer whatever tobacco/alcohol use assessment and intervention they typically would.

Primary Outcome Measure

Theory of Planned Behavior Intention subscale [ Time Frame: Baseline, 4-weeks, 8-weeks, 12-weeks, 16-weeks, 20-weeks, 24-weeks, 28-weeks, 32-weeks, 36-weeks, 40-weeks, 44-weeks, 48-weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Western New York Healthcare System, Buffalo, NYBuffaloNew York14215-1129
Mary A Blake
[email protected]
(716) 862-6527
Ali A El-Solh, MD MPH
[email protected]
(716) 862-6528
Julie Christina Gass, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
VA Western New York Healthcare System, Buffalo, NY· Buffalo, NY

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