[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100515808":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":18,"studyPopulation":18,"armGroups":30,"interventions":43,"overallOfficials":51,"centralContacts":56,"locations":66,"responsibleParty":309,"collaborators":18,"id":311,"slug":312,"hasResults":313,"nctId":314,"briefTitle":315,"officialTitle":315,"acronym":316,"eligibilityCriteria":317,"healthyVolunteers":313,"sex":318,"minAge":319,"maxAge":18,"enrollmentInfo":320,"targetDuration":18,"studyType":323,"phases":324,"briefSummary":326,"conditions":327,"keywords":18,"overallStatus":69,"whyStopped":18,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":338},{"fullName":5,"class":6},"VA Office of Research and Development","FED",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Number of pairwise comparisons with wins of Clinical Benefit, evaluated a hierarchical composite of days alive out of hospital and =5-point difference in the change of health-related quality of life","All patients randomized to intervention are compared to all patients randomized to placebo within strata. In each comparison with any two patients, a patient will win by achieving a superior clinical outcome which is determined by sequentially assessing the following criteria with evaluation halted when distinct advantage for either patient is shown:\n\n1. Days alive out of hospital at 6 weeks: shorter days is worse; tied, if same days alive out of hospital. Move to evaluation of 2 if tied.\n2. Change of The Kansas City Cardiomyopathy Questionnaire Clinical Summary (KCCQ-CS) at 6 weeks from baseline: the threshold for the difference is greater or equal to 5 for a win; tied, if difference is less than 5.\n\nThe KCCQ-CS ranges from 0 to 100, where a higher score reflects a better outcome.","within 6 weeks post-index hospital discharge",[14],{"measure":15,"description":16,"timeFrame":17},"DAOH at 6 months post-discharge","This outcome was selected to determine whether home-delivered meals, augmented by enhanced dietary counseling, during a high-risk period have durable effects on readmission burden.","6 months post-discharge",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":22,"primaryPurpose":23,"observationalModel":18,"timePerspective":18,"maskingInfo":24},"RANDOMIZED","PARALLEL","Two-arm study: active intervention vs study-defined standard of care","SUPPORTIVE_CARE",{"masking":25,"maskingDescription":26,"whoMasked":27},"DOUBLE","Due to the nature of the intervention, participants, dietitians, and site coordinators can't be blinded. However, the investigators and outcome assessors will be blinded",[28,29],"INVESTIGATOR","OUTCOMES_ASSESSOR",[31,37],{"label":32,"type":33,"description":34,"interventionNames":35},"Control","ACTIVE_COMPARATOR","Study-defined standard of care",[36],"Other: Study -defined standard of care",{"label":38,"type":39,"description":40,"interventionNames":41},"Home-delivered meals and short-term dietary counseling","EXPERIMENTAL","Home-delivered, low-sodium, nutritionally robust meals for 6 weeks plus three additional remotely delivered dietary counseling sessions in addition to the study-defined standard of care.",[42],"Other: Home-delivered meals and short-term dietary counseling",[44,47],{"type":45,"name":38,"description":40,"armGroupLabels":46,"otherNames":18},"OTHER",[38],{"type":45,"name":48,"description":49,"armGroupLabels":50,"otherNames":18},"Study -defined standard of care","Study-defined standard of care consists of standardized dietary education and a single dietary counseling session shortly after discharge",[32],[52],{"name":53,"affiliation":54,"role":55},"Scott L. Hummel, MD","VA Ann Arbor Healthcare System, Ann Arbor, MI","STUDY_CHAIR",[57,62],{"name":58,"role":59,"phone":60,"phoneExt":18,"email":61},"Yuan Huang","CONTACT","(203) 737-7966","Yuan.Huang1@va.gov",{"name":63,"role":59,"phone":64,"phoneExt":18,"email":65},"Shirley Joyner","(203) 932-5711","Shirley.Joyner@va.gov",[67,86,101,115,129,144,159,175,189,204,219,235,250,264,279,294],{"facility":68,"status":69,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Birmingham VA Medical Center, Birmingham, AL","RECRUITING","Birmingham","Alabama","35233-1927","United States","US",{"type":76,"coordinates":77},"Point",[78,79],-86.80249,33.52066,{"lat":79,"lon":78},[82],{"name":83,"role":59,"phone":84,"phoneExt":18,"email":85},"Fadi Hage, MD","(20-2)9-123)","fadi.hage@va.gov",{"facility":87,"status":69,"city":88,"state":89,"zip":90,"country":73,"countryCode":74,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"VA Long Beach Healthcare System, Long Beach, CA","Long Beach","California","90822",{"type":76,"coordinates":92},[93,94],-118.18923,33.76696,{"lat":94,"lon":93},[97],{"name":98,"role":59,"phone":99,"phoneExt":18,"email":100},"Jennifer Ballard-Hernandez, MD","(71-4)9-9808","jennifer.ballard-Hernandez@va.gov",{"facility":102,"status":69,"city":103,"state":89,"zip":104,"country":73,"countryCode":74,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"VA Palo Alto Health Care System, Palo Alto, CA","Palo Alto","94304-1207",{"type":76,"coordinates":106},[107,108],-122.14302,37.44188,{"lat":108,"lon":107},[111],{"name":112,"role":59,"phone":113,"phoneExt":18,"email":114},"Shriram Nallamshetty, MD","(65-049-000)","shriram.nallamshetty@va.gov",{"facility":116,"status":69,"city":117,"state":89,"zip":118,"country":73,"countryCode":74,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"VA Greater Los Angeles Healthcare System, West Los Angeles, CA","West Los Angeles","90073-1003",{"type":76,"coordinates":120},[121,122],-118.43068,34.0462,{"lat":122,"lon":121},[125],{"name":126,"role":59,"phone":127,"phoneExt":18,"email":128},"Alberta Warner, MD","(31-0)4-0866","alberta.warner@va.gov",{"facility":130,"status":69,"city":131,"state":132,"zip":133,"country":73,"countryCode":74,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Washington DC VA Medical Center, Washington, DC","Washington D.C.","District of Columbia","20422-0001",{"type":76,"coordinates":135},[136,137],-77.03637,38.89511,{"lat":137,"lon":136},[140],{"name":141,"role":59,"phone":142,"phoneExt":18,"email":143},"Pamela Steele, MD","(20-296-850)","pamela.steele@va.gov",{"facility":145,"status":69,"city":146,"state":147,"zip":148,"country":73,"countryCode":74,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"North Florida\u002FSouth Georgia Veterans Health System, Gainesville, FL","Gainesville","Florida","32608-1135",{"type":76,"coordinates":150},[151,152],-82.32483,29.65163,{"lat":152,"lon":151},[155],{"name":156,"role":59,"phone":157,"phoneExt":18,"email":158},"Carsten Schmalfuss, MD","(35-2)5-6234","carsten.schmalfuss@va.gov",{"facility":160,"status":69,"city":161,"state":162,"zip":163,"country":73,"countryCode":74,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"Atlanta VA Medical and Rehab Center, Decatur, GA","Decatur","Georgia","30033-4004",{"type":76,"coordinates":165},[166,167],-84.29631,33.77483,{"lat":167,"lon":166},[170],{"name":171,"role":59,"phone":172,"phoneExt":173,"email":174},"Priya Kohli, MD","(40-432-111)","202304","priya.kohli@va.gov",{"facility":54,"status":69,"city":176,"state":177,"zip":178,"country":73,"countryCode":74,"cosmosGeoPoint":179,"geoPoint":183,"contacts":184},"Ann Arbor","Michigan","48105-2303",{"type":76,"coordinates":180},[181,182],-83.74088,42.27756,{"lat":182,"lon":181},[185,188],{"name":186,"role":59,"phone":18,"phoneExt":18,"email":187},"Scott L Hummel, MD","Scott.Hummel@va.gov",{"name":53,"role":55,"phone":18,"phoneExt":18,"email":18},{"facility":190,"status":69,"city":191,"state":192,"zip":193,"country":73,"countryCode":74,"cosmosGeoPoint":194,"geoPoint":198,"contacts":199},"Minneapolis VA Health Care System, Minneapolis, MN","Minneapolis","Minnesota","55417-2309",{"type":76,"coordinates":195},[196,197],-93.26384,44.97997,{"lat":197,"lon":196},[200],{"name":201,"role":59,"phone":202,"phoneExt":18,"email":203},"Bradley Bart, MD","(61-2)4-6387","bradley.bart@va.gov",{"facility":205,"status":69,"city":206,"state":206,"zip":207,"country":73,"countryCode":74,"cosmosGeoPoint":208,"geoPoint":212,"contacts":213},"VA NY Harbor Healthcare System, New York, NY","New York","10010-5011",{"type":76,"coordinates":209},[210,211],-74.00597,40.71427,{"lat":211,"lon":210},[214],{"name":215,"role":59,"phone":216,"phoneExt":217,"email":218},"Sundar Natarajan, MD","(21-2)6-7500","3116","sundar.natarajan@va.gov",{"facility":220,"status":69,"city":221,"state":222,"zip":223,"country":73,"countryCode":74,"cosmosGeoPoint":224,"geoPoint":228,"contacts":229},"VA Portland Health Care System, Portland, OR","Portland","Oregon","97207-2964",{"type":76,"coordinates":225},[226,227],-122.67621,45.52345,{"lat":227,"lon":226},[230],{"name":231,"role":59,"phone":232,"phoneExt":233,"email":234},"Carrie Puckett, DO","(50-3) -8262","51181","carrie.puckett@va.gov",{"facility":236,"status":69,"city":237,"state":238,"zip":239,"country":73,"countryCode":74,"cosmosGeoPoint":240,"geoPoint":244,"contacts":245},"VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX","Dallas","Texas","75216-7167",{"type":76,"coordinates":241},[242,243],-96.80667,32.78306,{"lat":243,"lon":242},[246],{"name":247,"role":59,"phone":248,"phoneExt":18,"email":249},"Daniel Cheeran, MD","(21-4) -1472","Daniel.Cheeran@va.gov",{"facility":251,"status":69,"city":252,"state":238,"zip":253,"country":73,"countryCode":74,"cosmosGeoPoint":254,"geoPoint":258,"contacts":259},"Michael E. DeBakey VA Medical Center, Houston, TX","Houston","77030-4211",{"type":76,"coordinates":255},[256,257],-95.36327,29.76328,{"lat":257,"lon":256},[260],{"name":261,"role":59,"phone":262,"phoneExt":18,"email":263},"Savitri Fedson, MD","(71-3)7-7300","savitri.fedson@va.gov",{"facility":265,"status":69,"city":266,"state":267,"zip":268,"country":73,"countryCode":74,"cosmosGeoPoint":269,"geoPoint":273,"contacts":274},"VA Salt Lake City Health Care System, Salt Lake City, UT","Salt Lake City","Utah","84148-0001",{"type":76,"coordinates":270},[271,272],-111.89105,40.76078,{"lat":272,"lon":271},[275],{"name":276,"role":59,"phone":277,"phoneExt":18,"email":278},"Erik Bieging, MD","(60-865-780)","erik.bieging@va.gov",{"facility":280,"status":69,"city":281,"state":282,"zip":283,"country":73,"countryCode":74,"cosmosGeoPoint":284,"geoPoint":288,"contacts":289},"Richmond VA Medical Center, Richmond, VA","Richmond","Virginia","23249-0001",{"type":76,"coordinates":285},[286,287],-77.46026,37.55376,{"lat":287,"lon":286},[290],{"name":291,"role":59,"phone":292,"phoneExt":18,"email":293},"Michael Godschalk, MD","(80-467-429)","michael.godschalk@va.gov",{"facility":295,"status":69,"city":296,"state":297,"zip":298,"country":73,"countryCode":74,"cosmosGeoPoint":299,"geoPoint":303,"contacts":304},"William S. Middleton Memorial Veterans Hospital, Madison, WI","Madison","Wisconsin","53705-2254",{"type":76,"coordinates":300},[301,302],-89.40123,43.07305,{"lat":302,"lon":301},[305],{"name":306,"role":59,"phone":307,"phoneExt":18,"email":308},"David Murray, MD","(60-8)2-0080","david.murray@va.gov",{"type":310,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100515808","csp-2025---geriatric-out-of-hospital-randomized-meal-trial-in-heart-failure-veterans-affairs-gourmet-va-100515808",false,"NCT05996328","CSP #2025 - Geriatric OUt-of-hospital Randomized MEal Trial in Heart Failure: Veterans Affairs (GOURMET-VA)","GOURMET-VA","Inclusion Criteria:\n\n* Veterans enrolled in a VHA facility\n* Hospitalized ( 24 hours) with new HF or worsening chronic HF\n* Dentition, swallowing function, etc. sufficient to safely consume food and liquid of standard composition and texture (i.e., no pureed food, no thickened liquids needed)\n* Able and willing to provide informed consent and perform study activities\n\nExclusion Criteria:\n\n* Food allergies or intolerances that cannot be accommodated by study diet\n* On dialysis or estimated glomerular filtration rate \\\u003C30 at randomization\n* Serum potassium (non-hemolyzed) \\>6.0 mmol\u002FL during index hospitalization\n* Heart transplant or active transplant listing\n* Left ventricular assist device present or anticipated \\\u003C6 months\n* Malignancy or other non-cardiac condition limiting life expectancy to \\\u003C12 months\n* Planned admission to a skilled nursing facility following hospital discharge, or discharge to other location\u002Fsituation where Veteran does not have control over diet\n* Lack of space to store food for a week or equipment to prepare food\n* Severe cognitive impairment (SLUMS score \\\u003C20, or \\\u003C19 if less than high school education completed)\n* Severe food insecurity (5 or 6 points on the USDA 6-item Food Insecurity Screen)\n* Body mass index \\>50 kg\u002Fm2\n* Other medical, psychiatric, behavioral, or logistical condition which, in the clinical judgement of the site investigator, makes it unlikely the patient can effectively participate in or complete the study","ALL","60 Years",{"count":321,"type":322},1400,"ESTIMATED","INTERVENTIONAL",[325],"NA","The purpose of this multi-center clinical trial is to study the efficacy and safety of providing nutritional support added to the study-defined standard of care which consists of standardized dietary education and a single dietary counseling session shortly after discharge, versus study-defined standard of care alone.",[328],"Heart Failure","2026-08-11",{"date":331,"type":332},"2026-08-14","ACTUAL",{"date":334,"type":332},"2026-07-24",{"date":336,"type":322},"2030-10-31",{"name":5,"class":6},16]