[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06172491":3,"trial-entities:NCT06172491":106,"trial-summary:NCT06172491":109},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":30,"interventions":33,"primary_outcomes":34,"secondary_outcomes":46,"sex":47,"minimum_age":48,"maximum_age":28,"healthy_volunteers":28,"eligibility_criteria":49,"std_ages":58,"locations":61,"central_contacts":92,"overall_officials":99,"references":100,"see_also_links":105},"NCT06172491","22-003098","Automating Delirium Severity in the ICU","Harnessing the Power of Technology to Transform Delirium Severity Measurement in the ICU","RECRUITING","2028-05-31","2026-04","2026-04-08","2023-01-15","Mayo Clinic","OTHER",true,"The goal of this observational study is to develop a passive digital marker (PDM) for delirium severity and examine its performance in comparison to validated delirium severity tools in ICU patients \\>50 years of age.\n\nThe main questions it aims to answer are:\n\n* Is the trained convolutional neural network able to reliably measure delirium severity.\n* Is the Passive Digital Marker able to accurately measure delirium severity\n* Is the Passive Digital Marker acceptable and usable by frontline ICU nurse clinicians, patients, and their identified proxies (i.e., caregivers).\n\nParticipants will:\n\n* Study participation involves a video camera recording you 24 hours per day while you are a patient in the Intensive Care Unit (ICU).\n* Study staff will visit you 4 times each day you are in the ICU. You will be asked questions each time they visit to train the digital marker and see differences between assessments and camera data.","Bedside cameras will stay up for at least 72 hours (about 3 days), it may be longer if delirium is being experienced and if the patient and or LAR (Legally Authorized Representative) agree to the cameras' continued recording.\n\nThe study team will come and ask the patient questions 4 times daily. We will ask questions about their general, mental, and emotional health, their mood and memory. During these visits, the study team will check the alertness of the patient. Alertness will be checked by voice; if they do not respond, we will tap their shoulder gently. We will ask the patient to do activities like remembering words and saying them back, shaking hands, and drawing an object or clock. The study team will administer assessments 4 times daily. Participants will be asked questions about their general, mental, and emotional health, as well as mood and memory. While performing these sessions, the study team will observe the level of awareness. Awareness will be assessed by voice; if they do not respond, we will have to do a gentle tap on their shoulders. The patient will be asked to perform activities such as: remembering words and repeating them back, handshaking, and drawing an object or clock.\n\nIn some cases, if the patient's level of awareness alertness is lowered, we will do observation only perform observation assessments. These assessments do not interfere with clinical care. Participation in this study is voluntary.\n\nThe study team will continue to follow the patient until discharged from ICU.\n\nThe bedside nurse, patient, or family can cover the cameras with a washcloth if needed for privacy. The faces of family and clinicians and the bathing suit areas of patients are blurred before analysis to protect privacy.",[19,20,21],"Intensive Care Unit Delirium","Encephalopathy","Delirium",[21,23,24,25,26],"Severity","Digital marker","Computer Vision","Artificial Intelligence","OBSERVATIONAL",null,[],{"count":31,"type":32},400,"ESTIMATED",[],[35,39,43],{"measure":36,"description":37,"timeFrame":38},"Delirium Severity","The level of delirium severity will be measured by two types of prospective data collection. The first method is completed by study team members. A trained member of the study team will administer validated assessment tools 4xdaily from enrollment until ICU discharge or death. The Confusion Assessment Method for the Intensive Care Unit Severy Scale (CAM-ICU-7) is the gold standard for delirium severity measurement in the ICU. It is a 7-point scale, with 7 being severe delirium and 0 being no delirium. The second method is a passive digital marker (in development).","12-48 months",{"measure":40,"description":41,"timeFrame":42},"Acceptability of passive digital marker for delirium severity","Participants and their identified care partners will be randomized 1:1 to either the Passive Digital Marker for Delirium Severity or usual care. The acceptability of the PDM by clinicians, patients, and care partners will be evaluated. The 4-question tool named Treatment Acceptability and Preference Questionnaire (TAPQ) is scored on a 5-point Likert scale. A higher score indicates higher acceptability.","48 months - 60 months",{"measure":44,"description":45,"timeFrame":42},"Usability of passive digital marker for delirium severity","Participants and their identified care partners will be randomized 1:1 to either the Passive Digital Marker for Delirium Severity or usual care. The usability of the PDM by clinicians, patients, and care partners will be evaluated. The 10-question System Usability Scale is scored on a Likert scale from 1-5. A higher score (0-100 range) indicates higher usability.",[],"ALL","50 Years",{"inclusion":50,"exclusion":53,"raw_text":57},[51,52],"Estimated length of stay \\>24 hours in ICU; and","Are not admitted for acute alcohol intoxication, drug (prescribed or illicit) overdose or withdrawal.",[54,55,56],"Admitted for acute alcohol intoxication, drug (prescribed or illicit) overdose or withdrawal.","Admitted for acute neuronal injury","Unable to communicate with research team due to sensory deficits (aphasic, blind, deaf) or language (does not speak English)","Inclusion Criteria: • Age \\>50;\n\n* Estimated length of stay \\>24 hours in ICU; and\n* Are not admitted for acute alcohol intoxication, drug (prescribed or illicit) overdose or withdrawal.\n\nExclusion Criteria:\n\n* Admitted for acute alcohol intoxication, drug (prescribed or illicit) overdose or withdrawal.\n* Admitted for acute neuronal injury\n* Unable to communicate with research team due to sensory deficits (aphasic, blind, deaf) or language (does not speak English)",[59,60],"ADULT","OLDER_ADULT",[62],{"facility":13,"status":8,"city":63,"state":64,"zip":65,"country":66,"contacts":67,"geoPoint":89},"Rochester","Minnesota","55905","United States",[68,73,76,79,81,83,85,87],{"name":69,"role":70,"phone":71,"email":72},"Hannah Friesen","CONTACT","507-284-2197","friesen.hannah@mayo.edu",{"name":74,"role":75},"Heidi Lindroth, Ph.D., R.N.","PRINCIPAL_INVESTIGATOR",{"name":77,"role":78},"Anirban Bhattacharyya, M.D.,M.S","SUB_INVESTIGATOR",{"name":80,"role":78},"Arun Jayaraman, M.D,Ph.D",{"name":82,"role":78},"Linda Chlan, Ph.D",{"name":84,"role":78},"Vitaly Herasevich, M.D.,Ph.D",{"name":86,"role":78},"Alejandro Rabinstein, M.D.",{"name":88,"role":78},"Malaz Boustani, M.D. M.P.H.",{"lat":90,"lon":91},44.02163,-92.4699,[93,97],{"name":94,"role":70,"phone":95,"email":96},"Heidi Lindroth, PH.D. R.N.","507-284-3662","lindroth.heidi@mayo.edu",{"name":69,"role":70,"phone":98,"email":72},"1-507-284-2197",[],[101],{"pmid":102,"type":103,"citation":104},"40998312","DERIVED","Raghu R, Nalaie K, Ayala I, Morales Behaine JJ, Garcia-Mendez JP, Friesen H, Leistikow K, Bhattacharyya A, Jayaraman A, Franco PM, Rabinstein A, Chlan LL, Boustani M, Herasevich V, Lindroth H. Harnessing the Power of Technology to Transform Delirium Severity Measurement in the Intensive Care Unit: Protocol for a Prospective Cohort Study. JMIR Res Protoc. 2025 Sep 25;14:e62912. doi: 10.2196\u002F62912.",[],{"nct_id":4,"conditions":107,"biomarkers":108},[21,20],[],{"nct_id":4,"found":15,"summary":110,"prompt_version":119},{"design":111,"status":112,"heading":6,"summary":113,"follow_up":114,"word_count":115,"commitments":116,"compensation":117,"drugs_mentioned":118},"This is an observational study with a planned enrollment of 400 participants. It aims to develop and test a new method for measuring delirium severity.","completed","This observational study aims to develop a new way to measure how severe delirium is in patients over 50 years old who are in the Intensive Care Unit (ICU). Delirium is a serious change in mental abilities that results in confused thinking and reduced awareness of your surroundings. Researchers will use video cameras to record patients 24 hours a day and compare this information with standard delirium assessments. The goal is to see if this new \"passive digital marker\" can accurately measure delirium severity and if it is acceptable and easy to use for nurses, patients, and their families. The study plans to include 400 participants and is currently unclear about its recruitment status. You might be able to join if you are over 50, expected to stay in the ICU for more than 24 hours, and not admitted for alcohol or drug-related issues.","The study will measure delirium severity between 12 and 48 months, and the acceptability and usability of the digital marker between 48 and 60 months.",144,"Study participation involves 24-hour video camera recording while you are in the ICU. Study staff will visit you four times daily to ask questions and perform assessments of your mental and emotional health, mood, memory, and alertness.","Not stated in the trial record.",[],"v2"]