[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06006000":3,"trial-entities:NCT06006000":95,"trial-summary:NCT06006000":98},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":23,"primary_purpose":14,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":29,"secondary_outcomes":44,"sex":48,"minimum_age":49,"maximum_age":14,"healthy_volunteers":50,"eligibility_criteria":51,"std_ages":71,"locations":73,"central_contacts":83,"overall_officials":89,"references":93,"see_also_links":94},"NCT06006000","2000034943","Evaluating the Unmet Needs of Older Adults to Promote Functional Recovery After a Critical Illness","RECRUITING","2028-10","2026-06","2026-06-17","2024-01-25","Yale University","OTHER",null,"This is a prospective longitudinal study that will evaluate the unmet needs of older adults (65 and older) who return home (either directly or after short-term rehab) after an ICU hospitalization, evaluate the association of these unmet needs with clinically relevant outcomes, and assess barriers and facilitators to addressing these unmet needs. The proposed research will inform the development and evaluation of a subsequent intervention to improve functional outcomes among older ICU survivors, in alignment with the NIH's mission to reduce disability.","To identify unmet needs in multiple domains after return home from an ICU hospitalization, evaluate whether these unmet needs are associated with disability burden in the subsequent 6 months, and ascertain whether these associations are moderated by initial discharge destination (home or STR).",[18,19],"Critical Illness","Illness, Critical",[21,22],"Geriatrics","Older Adults","OBSERVATIONAL",[],{"count":26,"type":27},350,"ESTIMATED",[],[30,34,37,40],{"measure":31,"description":32,"timeFrame":33},"Disability Count","Number of instances of disability during activities of daily living (ADLs), instrumental activities of daily living (IADLs), and mobility activity. Disability is defined as an inability to complete the task or the need for personal assistance to complete the task. The higher the count, the more disability.","monthly up to 6 months",{"measure":35,"description":36,"timeFrame":33},"Number of hospital readmissions","Number of hospital readmissions monthly up to 6 months.",{"measure":38,"description":39,"timeFrame":33},"Number of deaths","Number of deaths each month up to 6 months.",{"measure":41,"description":42,"timeFrame":43},"Barriers and Facilitators to addressing unmet needs","Barriers and facilitators to addressing unmet needs will be assessed using qualitative interviews. A subgroup of participants will receive qualitative interviews conducted with members of the study team. Content analysis will then be used to identify barriers and facilitators to addressing unmet needs that will be informative when planning a future intervention.","month 6",[45],{"measure":46,"description":47,"timeFrame":33},"Functional non-recovery","Not returning to the pre-ICU functional baseline within the follow-up period","ALL","65 Years",false,{"inclusion":52,"exclusion":57,"raw_text":70},[53,54,55,56],"Age ≥ 65 years","Survived an ICU admission of ≥2 days","Age ≥ 18 years","Identified as caregiver of LANTERN participant who is an informal (unpaid) caregiver.",[58,59,60,61,62,63,64,65,66,67,68,69],"Advance directive of comfort measures only (CMO) or a transition to hospice","Planned discharge to a location other than home or Short-Term Rehab","Tracheostomy with ventilator dependence","Severe acute or prior neurologic injury (such as anoxic brain injury or acute, massive stroke)","Advanced dementia","ICU admission for monitoring only (e.g., antibiotic desensitization)","Primary language other than English.","Homelessness","Active drug or alcohol use disorder.","Primary language other than English","Is a paid caregiver","Unwilling to complete a qualitative interview","Inclusion Criteria:\n\nPARTICIPANTS\n\n* Age ≥ 65 years\n* Survived an ICU admission of ≥2 days\n\nCAREGIVERS\n\n* Age ≥ 18 years\n* Identified as caregiver of LANTERN participant who is an informal (unpaid) caregiver.\n\nExclusion Criteria:\n\nPARTICIPANTS\n\n* Advance directive of comfort measures only (CMO) or a transition to hospice\n* Planned discharge to a location other than home or Short-Term Rehab\n* Tracheostomy with ventilator dependence\n* Severe acute or prior neurologic injury (such as anoxic brain injury or acute, massive stroke)\n* Advanced dementia\n* ICU admission for monitoring only (e.g., antibiotic desensitization)\n* Primary language other than English.\n* Homelessness\n* Active drug or alcohol use disorder.\n\nCAREGIVERS\n\n* Primary language other than English\n* Is a paid caregiver\n* Unwilling to complete a qualitative interview",[72],"OLDER_ADULT",[74],{"facility":75,"status":7,"city":76,"state":77,"zip":78,"country":79,"geoPoint":80},"Yale New Haven Hospital","New Haven","Connecticut","06520","United States",{"lat":81,"lon":82},41.30815,-72.92816,[84],{"name":85,"role":86,"phone":87,"email":88},"Nicole Bouranis, PhD","CONTACT","+1 (203) 737-1731","nicole.bouranis@yale.edu",[90],{"name":91,"affiliation":12,"role":92},"Lauren Ferrante, MD, MHS","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":96,"biomarkers":97},[18],[],{"nct_id":4,"found":99,"summary":100,"prompt_version":110},true,{"design":101,"status":102,"heading":103,"summary":104,"follow_up":105,"word_count":106,"commitments":107,"compensation":108,"drugs_mentioned":109},"This is an observational study that plans to include about 350 participants. It will follow participants over time to understand their needs.","completed","Understanding Needs After Critical Illness for Older Adults","This study is looking at the needs of older adults (65 and older) after they've been in an intensive care unit (ICU) for at least two days and then return home. It's an observational study, meaning researchers will watch and learn without giving any specific treatments. They want to understand what challenges you might face and how those challenges affect your recovery over six months. They will also look at why some needs are met and others aren't. The goal is to help design better support programs in the future. We don't know the current recruitment status.","Participants will be followed for up to 6 months to measure disability, hospital readmissions, and deaths.",97,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]