[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100492394":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":22,"centralContacts":23,"locations":29,"responsibleParty":47,"collaborators":22,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":22,"enrollmentInfo":61,"targetDuration":22,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":22,"overallStatus":32,"whyStopped":22,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Centre Hospitalier Universitaire Vaudois","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"doll therapy","EXPERIMENTAL","The doll used in the study is the \"empathy doll\"; these dolls are designed to obtain an optimal interaction with patients and to arouse empathy",[13],"Other: doll therapy",{"label":15,"type":6,"description":16,"interventionNames":17},"non anthropomorphic object","non- anthropomorphic soft object",[13],[19],{"type":6,"name":9,"description":20,"armGroupLabels":21,"otherNames":22},"empathy dolls",[9,15],null,[24],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},"Patrizia D Amelio, MD, PhD","CONTACT","+41213143712","patrizia.damelio@chuv.ch",[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"geriatric and Geriatric Rehabilitation Unit","RECRUITING","Lausanne","Canton of Vaud","1011","Switzerland","CH",{"type":39,"coordinates":40},"Point",[41,42],6.63282,46.516,{"lat":42,"lon":41},[45],{"name":46,"role":26,"phone":27,"phoneExt":22,"email":28},"Patrizia D'Amelio, MD, PhD",{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","Patrizia D'Amelio","Full professor, head of the geriatric and Geriatric rehabilitation Service","100492394","efficacy-of-doll-therapy-in-the-dementia-in-acute-geriatric-inpatients-100492394",false,"NCT05691569","Efficacy of Doll Therapy in the Dementia in Acute Geriatric Inpatients","Efficacy of Doll Therapy in the Control of Behavioral and psychologIcal Symptoms of Dementia in Acute Geriatric Inpatients: the AGITATE Study.","AGITATE","Inclusion Criteria:\n\n* age ≥65 years\n* diagnosis of dementia moderate to severe Clinical Dementia Rating scale (CDR) ≥2\n* presence of agitation and\u002For aggressiveness\n* manual and visual abilities sufficient in order to interact with the doll.\n\nExclusion Criteria:\n\n* age \\\u003C65 years;\n* refuse to participate;\n* mild forms of dementia (CDR\\\u003C2);\n* contraindication for DT as experience of mournful or traumatic events related to parental experience;\n* life expectancy lower than 3 months;\n* infectious diseases requiring isolation;\n* negative interaction with the doll,\n* presence of delirium.","ALL","65 Years",{"count":62,"type":63},92,"ESTIMATED","INTERVENTIONAL",[66],"NA","Summary. Behavioral and psychological symptoms of dementia (BPSD) represents a huge emotional stress and an important burden for the patients and the caregivers severely reducing their quality of life. BPSD worsen during hospitalization and require the administration of psychotropic drugs that are often insufficient to control the symptoms, and may cause severe adverse events.\n\nThe investigators propose the use of empathy dolls in order to reduce BPSD and in particular agitation and aggressiveness in acute geriatric in-patients affected by moderate to severe forms of dementia.\n\nThe use of doll therapy in the clinical routine will allow to reduce the use of psychotropic drugs, shorten hospitalization, reduce professional and family caregiver burden improving patients' and families' quality of life.",[69],"Dementia","2025-04-07",{"date":72,"type":73},"2025-04-09","ACTUAL",{"date":75,"type":73},"2024-11-15",{"date":77,"type":63},"2027-08-30",{"name":5,"class":6},1]