[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549676":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":19,"locations":29,"responsibleParty":49,"collaborators":53,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":10,"enrollmentInfo":74,"targetDuration":10,"studyType":77,"phases":10,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":32,"whyStopped":10,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"University of Bergen","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Participants",null,"Persons with dementia",[13],"Other: No intervention",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"No intervention","The study is observational and will not include any specific interventions other than the regular care practice that the participants receive from their care providers. The study will use a wrist-mounted smartwatch for monitoring (Garmin VivoActive5). Previous studies show acceptability toward wearable devices among persons with dementia. Moreover, the investigator will use Somnofy, VitalThings, a radar installation mounted behind the patients bed. At the very end of life, the investigator will also apply Shimmer3 Ebio sensor measuring the patients breathing activities. Before starting the data collection, care staff will recognize any discomfort or distress potentially caused by the devices, in which case the relevant device will be immediately removed.",[9],[20,25],{"name":21,"role":22,"phone":23,"phoneExt":10,"email":24},"Bettina S. Husebø, PhD","CONTACT","48094660","bettina.husebo@uib.no",{"name":26,"role":22,"phone":27,"phoneExt":10,"email":28},"Monica Patrascu, PhD","91198669","monica.patrascu@uib.no",[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Bergen Røde Kors Sykehjem AS","RECRUITING","Bergen","Vestland","5043","Norway","NO",{"type":39,"coordinates":40},"Point",[41,42],5.32415,60.39299,{"lat":42,"lon":41},[45],{"name":46,"role":22,"phone":47,"phoneExt":10,"email":48},"Morten Amundsen","+4755397700","postmottak@brks.no",{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Bettina Husebo","Prof, MD, PhD",[54,56,58,60,62],{"name":55,"class":6},"Leiden University",{"name":57,"class":6},"Harvard University",{"name":59,"class":6},"Yale University",{"name":61,"class":6},"Tohoku University",{"name":63,"class":64},"Bergen kommune","UNKNOWN","100549676","decoding-death-and-dying-in-people-with-dementia-by-digital-thanotyping-100549676",false,"NCT06437132","Decoding Death and Dying in People With Dementia by Digital Thanotyping","5-D","Inclusion Criteria:\n\n* Nursing home resident\n* \\>64 years old\n* People with dementia or who have a likely diagnosis of dementia\n* Score of \\\u003C4 on the 4 A's Test for Delirium (4AT) will be required for inclusion (no delirium)\n\nExclusion Criteria:\n\n* People without dementia or cognitive impairment\n* People that are considered already in a health status emergency (\\\u003C 6 weeks to live)\n* People that are not living in the nursing home\n* People without informed\u002Fpresumed consent","ALL","65 Years",{"count":75,"type":76},480,"ESTIMATED","OBSERVATIONAL","How can healthcare professionals recognize that a person with dementia is at the end of life? When people are dying, their physical, mental, and social abilities are gradually declining. No reliable method of predicting perceived dying currently exists although the technology is available (sensors, algorithms).\n\nThe aim of Decoding Death and Dying in Dementia by Digital thanotyping (5-D) is to provide methods and tools to diagnose and describe dying to an unprecedented level of accuracy and robustness, within a timespan larger than is possible now, focusing on the case of dying people with dementia as one of the most vulnerable and difficult to study groups. 5-D combines clinical assessment tools with wearable sensing technology to monitor a) pain and distressing symptoms, b) behavioral and psychological symptoms in dementia (BPSD), c) oral changes, and to decode \"the point of no return\" as the beginning of perceived dying.\n\nTo obtain this outcome in nursing home patients with dementia, the investigator will test the main hypothesis: from monitoring the evolution of thanotype components over time and their interdependencies, the prediction of the \"point of no return\" is possible. The objectives of 5-D are:\n\nO1. Collect data using sensors and validated assessment scales. O2. Develop estimation methods for BPSD from sensor measurements. O3. Develop digital tools to capture the expression of pain. O4. Determine the relationship between breathing and oral symptoms. O5. Develop models for symptom interdependencies at the end of life and the \"point of no return\".\n\nO6. Perform human-in-the-loop validation of developed tools, models, and algorithms.\n\nThe ground-breaking interdisciplinary novelty of 5-D endeavors to enhance the understanding of end-of-life underlying pain and symptoms in people with dementia. Advancing our theoretical knowledge to uncover how, when, and why perceived dying can be identified opens the doors for transferable research across several scientific fields",[80],"Dementia",[82,83,84,85,86,87],"end of life","dementia","nursing home","pain assessment and treatment","symptom assessment and treatment","mouth care","2024-05-25",{"date":90,"type":91},"2024-05-31","ACTUAL",{"date":93,"type":91},"2024-01-01",{"date":95,"type":76},"2028-12-31",{"name":5,"class":6},1]