Evaluating the Unmet Needs of Older Adults to Promote Functional Recovery After a Critical Illness

NCT ID: NCT06006000

Last Updated: 2025-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

650 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-25

Study Completion Date

2028-10-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Critical Illness Illness, Critical

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lauren Ferrante, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale New Haven Hospital

New Haven, Connecticut, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Nicole Bouranis, PhD

Role: CONTACT

+1 (203) 737-1731

Other Identifiers

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1R01AG079916-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000034943

Identifier Type: -

Identifier Source: org_study_id

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