Recruiting

Observational Study

Sponsor:

Yale University

Code:

NCT06006000

Conditions

Critical Illness

Illness, Critical

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Critical Illness

Illness, Critical

Study ID

NCT06006000

Start date

Jan 25, 2024

Status verified date

Jun, 2026

Completion date

Oct, 2028

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Inclusion Criteria:

PARTICIPANTS

  • Age ≥ 65 years
  • Survived an ICU admission of ≥2 days

CAREGIVERS

  • Age ≥ 18 years
  • Identified as caregiver of LANTERN participant who is an informal (unpaid) caregiver.

Exclusion Criteria:

PARTICIPANTS

  • 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.

CAREGIVERS

  • Primary language other than English
  • Is a paid caregiver
  • Unwilling to complete a qualitative interview

Study Design

Enrollment

350 participants

Anticipated

Interventions and Outcome Measures

Arms

Older adults returning home post-ICU

Community-dwelling older adults who return home (either directly or after a stay in short-term rehab (STR)) after an ICU hospitalization.

Primary outcome measure

  • Disability Count [ Time Frame: monthly up to 6 months ]
  • Number of hospital readmissions [ Time Frame: monthly up to 6 months ]
  • Number of deaths [ Time Frame: monthly up to 6 months ]
  • Barriers and Facilitators to addressing unmet needs [ Time Frame: month 6 ]

Central Contacts and Locations

Central contacts

Nicole Bouranis, PhD

+1 (203) 737-1731nicole.bouranis@yale.edu

Locations

Yale New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06520

More Information

Sponsor

Yale University

Last update posted

Jun 17, 2026

Last verified

Jun, 2026

Keywords

  • Geriatrics
  • Older Adults

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-06-17.