Helping Veterans with chronic disease reduce smoking and risky drinking
A Low-Cost, High-Access Intervention to Increase Intention to Change Alcohol/Tobacco Use Among Reticent Veterans Who Are Non-Responders to Brief Advice at High Risk Due to Chronic Conditions
This program will test whether a mailed, tailored education packet plus a brief motivational phone call helps Veterans with diabetes, heart disease, or related risk factors who smoke or drink too much become more motivated to change.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 270 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Buffalo, New York) |
| Trial ID | NCT07039175 on ClinicalTrials.gov |
What this trial studies
This is a randomized, phase 3 trial comparing a proactive, low-resource intervention called MINDSET to usual primary care. MINDSET delivers a mailed packet with tailored education linking smoking and drinking to the participant's chronic condition, followed by a brief motivational telephone call. The study measures changes in intention to change, substance use behaviors, and related variables over time. Outcomes will be compared between the MINDSET group and usual care to determine effectiveness for reticent Veterans.
Who should consider this trial
Good fit: Ideal candidates are Veterans aged 18 or older who receive VA primary care at the Buffalo VA, have diabetes, cardiovascular disease, or a cardiovascular risk factor, are current smokers and/or screen positive for hazardous drinking on two consecutive prior screens, use VA care regularly, and have a scheduled primary care appointment during the intervention period.
Not a fit: Patients with severe cognitive impairment, those not currently smoking or drinking hazardously, Veterans who already engage with higher-intensity cessation or alcohol treatment, or those who do not receive care at the Buffalo VA are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, MINDSET could increase motivation to reduce smoking and hazardous drinking and potentially lower substance use and related chronic disease complications among Veterans.
How similar studies have performed: A prior pilot of MINDSET showed promise, and related brief motivational interventions using mailed materials and phone calls have produced modest positive effects, though large randomized trials in this specific population remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* an active diagnosis of diabetes, cardiovascular disease (CVD), or a cardiovascular risk factor (hypertension {HTN}, hyperlipidemia {HLD}) AND signs of reticence to change their smoking and/or alcohol use as evidenced by the two consecutive prior screens being positive for hazardous (e.g., Alcohol Use Disorders Test-Consumption \[AUDC\], and/or smoking (I.e., whether they are a current smoker or not).
* Confirmation of smoking and/or drinking status during telephone screening (e.g., Alcohol Use Disorders Test-Consumption \[AUDC\], and/or smoking (I.e., whether they are a current smoker or not).
* Veteran
* Age 18 years
* utilize VA for medical care more than 1 time per year
* are due to complete their smoking/alcohol use screen in approximately 3 months (to ensure they will likely receive UC during intervention period)
* a scheduled PC appointment within the intervention period.
Exclusion Criteria:
* dementia or severe cognitive impairment per Problem List
* significant visual impairment per Problem List
* Other Exclusion criteria assessed by study staff during screening/self-report are:
* inability to communicate or read in English;
* Hearing impairment; and
* cognitive impairment or screening for cognitive impairment (\>=weighted score of 10 on Blessed screener).
Where this trial is running
Buffalo, New York
- VA Western New York Healthcare System, Buffalo, NY — Buffalo, New York, United States (Recruiting)
Study contacts
- Principal investigator: Julie Christina Gass, PhD — VA Western New York Healthcare System, Buffalo, NY
- Study coordinator: Julie C Gass, PhD
- Email: Julie.Gass@va.gov
- Phone: (716) 834-9200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.