[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100510689":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":37,"locations":43,"responsibleParty":155,"collaborators":158,"id":177,"slug":178,"hasResults":179,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":179,"sex":185,"minAge":186,"maxAge":25,"enrollmentInfo":187,"targetDuration":25,"studyType":190,"phases":191,"briefSummary":193,"conditions":194,"keywords":205,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":217},{"fullName":5,"class":6},"University of Michigan","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Hospital Elder Life Program (HELP)","ACTIVE_COMPARATOR","Hospital Elder Life Program (HELP) is built upon multicomponent, non-pharmacologic strategies that target delirium risk factors to optimize cognitive and clinical function during hospitalization.",[13],"Behavioral: HELP",{"label":15,"type":10,"description":16,"interventionNames":17},"Family-Augmented Hospital Elder Life Program (FAM-HELP)","The FAM-HELP program will incorporate a family member and\u002For care partner, who will play a central role with providing bedside support for delirium risk reduction. Family members and care partners will provide social and emotional support along with augmentation of HELP-based protocols.",[18],"Behavioral: FAM-HELP",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","HELP","This is usual (standard) care across hospitals in this trial. A multidisciplinary team of nurse specialists, social workers, and volunteers implement daily protocols focused on orientation, cognitive stimulation, early mobilization, sleep enhancement, support with visual and hearing aids, mealtime assistance, hydration, reduction in polypharmacy, and nursing-based delirium prevention protocols.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"FAM-HELP","Family members and care partners will provide daily emotional and social support during hospitalization. Additionally, family members and care partners will engage in HELP-based protocols throughout the day. The rationale for this protocol augmentation is two-fold: (1) HELP may not consistently have available volunteers (e.g., short-staffing) during a hospital stay, and (2) patients may be more likely to engage in therapeutic activities with a family member given the connection and comfort level.",[15],[31,35],{"name":32,"affiliation":33,"role":34},"Sharon K Inouye, MD","Hebrew SeniorLife","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":5,"role":34},"Phillip E Vlisides, MD",[38],{"name":39,"role":40,"phone":41,"phoneExt":25,"email":42},"Eva Schmitt, PhD","CONTACT","617-971-5390","EvaSchmitt@hsl.harvard.edu",[44,63,78,96,111,125,140],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Saddleback Medical Center","RECRUITING","Orange","California","92868","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-117.85311,33.78779,{"lat":56,"lon":55},[59],{"name":60,"role":40,"phone":61,"phoneExt":25,"email":62},"Elizabeth Chassagne, BSN, RN, NE-BC","949-452-3969","EChassagne@memorialcare.org",{"facility":64,"status":46,"city":65,"state":66,"zip":67,"country":50,"countryCode":51,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"MaineHealth","Portland","Maine","04102",{"type":53,"coordinates":69},[70,71],-70.2589,43.65737,{"lat":71,"lon":70},[74],{"name":75,"role":40,"phone":76,"phoneExt":25,"email":77},"Emily Carter, MD","207-662-3157","Emily.Carter1@mainehealth.org",{"facility":79,"status":46,"city":80,"state":81,"zip":82,"country":50,"countryCode":51,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Michigan Medicine","Ann Arbor","Michigan","48109",{"type":53,"coordinates":84},[85,86],-83.74088,42.27756,{"lat":86,"lon":85},[89,93],{"name":90,"role":40,"phone":91,"phoneExt":25,"email":92},"Jocelyn Wiggins, MD","734-647-7299","wiggi@med.umich.edu",{"name":94,"role":40,"phone":91,"phoneExt":25,"email":95},"Shenbagam Dewar, MBBS","sdewar@med.umich.edu",{"facility":97,"status":46,"city":98,"state":99,"zip":100,"country":50,"countryCode":51,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Hospital of the University of Pennsylvania","Philadelphia","Pennsylvania","19104",{"type":53,"coordinates":102},[103,104],-75.16362,39.95238,{"lat":104,"lon":103},[107],{"name":108,"role":40,"phone":109,"phoneExt":25,"email":110},"Rebecca Trotta, PhD","215-615-4925","Rebecca.Trotta@pennmedicine.upenn.edu",{"facility":112,"status":46,"city":113,"state":99,"zip":114,"country":50,"countryCode":51,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Allegheny General Hospital","Pittsburgh","15212",{"type":53,"coordinates":116},[117,118],-79.99589,40.44062,{"lat":118,"lon":117},[121],{"name":122,"role":40,"phone":123,"phoneExt":25,"email":124},"Lyn Weinberg, MD","412-235-5810","Lyn.WEINBERG@ahn.org",{"facility":126,"status":46,"city":127,"state":128,"zip":129,"country":50,"countryCode":51,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"University of Utah","Salt Lake City","Utah","84132",{"type":53,"coordinates":131},[132,133],-111.89105,40.76078,{"lat":133,"lon":132},[136],{"name":137,"role":40,"phone":138,"phoneExt":25,"email":139},"Roxanne Weiss, MD","210-462-6266","Roxanne.Weiss@hsc.utah.edu",{"facility":141,"status":46,"city":142,"state":143,"zip":144,"country":50,"countryCode":51,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"Meriter Hospital","Madison","Wisconsin","53715",{"type":53,"coordinates":146},[147,148],-89.40123,43.07305,{"lat":148,"lon":147},[151],{"name":152,"role":40,"phone":153,"phoneExt":25,"email":154},"Carrie Bennett, DNP","(608) 417-5724","carrie.bennett@unitypoint.org",{"type":34,"investigatorFullName":156,"investigatorTitle":157,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Phillip Vlisides","Associate Professor of Anesthesiology; Executive Director, Neuroscience Research",[159,160,161,163,165,168,169,171,173,175],{"name":33,"class":6},{"name":64,"class":6},{"name":162,"class":6},"University of Pennsylvania",{"name":164,"class":6},"West Penn Allegheny Health System",{"name":166,"class":167},"UnityPoint Health - Meriter Hospital","UNKNOWN",{"name":126,"class":6},{"name":170,"class":167},"MemorialCare Saddleback Medical Center",{"name":172,"class":6},"Brandeis University",{"name":174,"class":6},"Indiana University",{"name":176,"class":6},"Patient-Centered Outcomes Research Institute","100510689","evaluating-novel-healthcare-approaches-to-nurturing-and-caring-for-hospitalized-elders-100510689",false,"NCT05929703","Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders","Evaluating Novel Healthcare Approaches to Nurturing and Caring for Hospitalized Elders (ENHANCE)","ENHANCE","Inclusion Criteria:\n\n* Provision of informed consent\n* At least 70 years of age\n* Anticipated length of hospital stay at least 72 hours\n* Family member or care partner available to be on-site in the hospital\n* At least one delirium risk factor (e.g., cognitive or functional impairment, dehydration, vision or hearing impairment)\n* Evaluable cognitive function at baseline (i.e., ability to complete baseline cognitive function assessment)\n\nExclusion Criteria:\n\n* Delirium on admission\n* Unable to communicate verbally (e.g., coma, mechanical ventilation)\n* Unable to participate fully in interventions (e.g., terminal condition, advanced dementia)\n* Staff safety concerns (e.g., violent behavior)\n* Cardiac or intracranial surgery (due to competing causes of delirium)","ALL","70 Years",{"count":188,"type":189},1900,"ESTIMATED","INTERVENTIONAL",[192],"NA","The goal of this clinical trial is to compare the Hospital Elder Life Program (HELP) with a family-augmented version of HELP (FAM-HELP), that includes family members and care partners, for the prevention of delirium in older patients during hospital admission. The main objectives of the trial are the following:\n\n1. To compare the effectiveness of FAM-HELP and HELP in reducing both the incidence of delirium and its severity.\n2. To compare the effectiveness of FAM-HELP and HELP in improving patient- and family-reported outcomes.\n3. To explore the implementation context, process, and outcomes of the FAM-HELP program in diverse hospital settings.",[195,196,197,198,199,200,201,202,203,204],"Delirium","Neurocognitive Disorders","Mild Cognitive Impairment","Alzheimer Disease","Aging","Family Support","Family Members","Caregiver Burden","Implementation Science","Patient Satisfaction",[195,206,207,203],"Clinical Trial","Comparative Effectiveness Research","2026-03-20",{"date":210,"type":211},"2026-03-24","ACTUAL",{"date":213,"type":211},"2023-12-04",{"date":215,"type":189},"2027-08",{"name":5,"class":6},7]