[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595955":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":42,"locations":53,"responsibleParty":78,"collaborators":71,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":23,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":71,"enrollmentInfo":89,"targetDuration":71,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":55,"whyStopped":71,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"VA Office of Research and Development","FED",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"MINDSET+UC","EXPERIMENTAL","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\u002Fdrinking on chronic disease and the benefits of stopping, followed by a brief motivational telephone booster call from a behavioral health provider.",[13],"Behavioral: MINDSET",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Care","ACTIVE_COMPARATOR","All Veterans in this study will have a primary care appointment during which their primary care team will administer whatever tobacco\u002Falcohol use assessment and intervention they typically would.",[19],"Other: Usual Care",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","MINDSET","A behavior-change model informed mailed informational packet with tailored health information regarding the impacts of smoking\u002Fdrinking on chronic disease and the benefits of stopping, followed by a brief motivational telephone booster call from a behavioral health provider.",[9],[27],"Motivational INtervention Designed for Self-management and EducaTion",{"type":29,"name":15,"description":30,"armGroupLabels":31,"otherNames":32},"OTHER","All Veterans involved in this study will have a standard primary care (PC) appointment, which may include conversations\u002Finterventions related to drinking and smoking. This appointment is not controlled by the study team and we cannot comment on the extent to which smoking\u002Fdrinking will or will not be discussed in the primary care appointment but we imagine this can range from no discussion\u002Fintervention at all to extensive conversations with the provision of medications, brief advice, etc.",[15],[33],"UC",[35,39],{"name":36,"affiliation":37,"role":38},"Julie Christina Gass, PhD","VA Western New York Healthcare System, Buffalo, NY","PRINCIPAL_INVESTIGATOR",{"name":40,"affiliation":41,"role":38},"Jennifer S Funderburk, PhD","Syracuse VA Medical Center, Syracuse, NY",[43,49],{"name":44,"role":45,"phone":46,"phoneExt":47,"email":48},"Julie C Gass, PhD","CONTACT","(716) 834-9200","5429","Julie.Gass@va.gov",{"name":40,"role":45,"phone":50,"phoneExt":51,"email":52},"(315) 425-4400","54703","Jennifer.Funderburk@va.gov",[54],{"facility":37,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"RECRUITING","Buffalo","New York","14215-1129","United States","US",{"type":62,"coordinates":63},"Point",[64,65],-78.87837,42.88645,{"lat":65,"lon":64},[68,73,77],{"name":69,"role":45,"phone":70,"phoneExt":71,"email":72},"Mary A Blake","(716) 862-6527",null,"mary.blake@va.gov",{"name":74,"role":45,"phone":75,"phoneExt":71,"email":76},"Ali A El-Solh, MD MPH","(716) 862-6528","ali.el-solh@va.gov",{"name":36,"role":38,"phone":71,"phoneExt":71,"email":71},{"type":79,"investigatorFullName":71,"investigatorTitle":71,"investigatorAffiliation":71,"oldNameTitle":71,"oldOrganization":71},"SPONSOR","100595955","phase-3-intervention-to-increase-intention-to-change-alcoholtobacco-use-in-veterans-with-chronic-disease-100595955",false,"NCT07039175","Intervention to Increase Intention to Change Alcohol\u002FTobacco Use in Veterans With Chronic Disease","A Low-Cost, High-Access Intervention to Increase Intention to Change Alcohol\u002FTobacco Use Among Reticent Veterans Who Are Non-Responders to Brief Advice at High Risk Due to Chronic Conditions","Inclusion Criteria:\n\n* 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\u002For alcohol use as evidenced by the two consecutive prior screens being positive for hazardous (e.g., Alcohol Use Disorders Test-Consumption \\[AUDC\\], and\u002For smoking (I.e., whether they are a current smoker or not).\n* Confirmation of smoking and\u002For drinking status during telephone screening (e.g., Alcohol Use Disorders Test-Consumption \\[AUDC\\], and\u002For smoking (I.e., whether they are a current smoker or not).\n* Veteran\n* Age 18 years\n* utilize VA for medical care more than 1 time per year\n* are due to complete their smoking\u002Falcohol use screen in approximately 3 months (to ensure they will likely receive UC during intervention period)\n* a scheduled PC appointment within the intervention period.\n\nExclusion Criteria:\n\n* dementia or severe cognitive impairment per Problem List\n* significant visual impairment per Problem List\n* Other Exclusion criteria assessed by study staff during screening\u002Fself-report are:\n\n  * inability to communicate or read in English;\n  * Hearing impairment; and\n  * cognitive impairment or screening for cognitive impairment (\\>=weighted score of 10 on Blessed screener).","ALL","18 Years",{"count":90,"type":91},270,"ESTIMATED","INTERVENTIONAL",[94],"PHASE3","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\u002Fsmoking 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\u002Fsmoking relate to the Veteran's condition (heart conditions and\u002For 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.",[97,98],"Tobacco Smoking","Alcohol-Related Disorders",[100,101,102,103,104,105,106],"Chronic Disease","Smoking","Drinking, Alcohol","Cardiovascular Risk","Health Behavior","Medicine, Behavioral","telehealth","2025-12-23",{"date":109,"type":110},"2025-12-31","ACTUAL",{"date":112,"type":110},"2025-10-01",{"date":114,"type":91},"2029-06-30",{"name":5,"class":6},1]