[{"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":84,"collaborators":18,"id":86,"slug":18,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":93,"maxAge":18,"enrollmentInfo":94,"targetDuration":18,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":18,"overallStatus":103,"whyStopped":18,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"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 two 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],{"facility":54,"status":18,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Ann Arbor","Michigan","48105-2303","United States","US",{"type":74,"coordinates":75},"Point",[76,77],-83.74088,42.27756,{"lat":77,"lon":76},[80,83],{"name":81,"role":59,"phone":18,"phoneExt":18,"email":82},"Scott L Hummel, MD","Scott.Hummel@va.gov",{"name":53,"role":55,"phone":18,"phoneExt":18,"email":18},{"type":85,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","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* aged 60 years\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":95,"type":96},1400,"ESTIMATED","INTERVENTIONAL",[99],"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.",[102],"Heart Failure","NOT_YET_RECRUITING","2026-06-18",{"date":106,"type":107},"2026-06-23","ACTUAL",{"date":109,"type":96},"2026-07-15",{"date":111,"type":96},"2030-10-31",{"name":5,"class":6},1]