NCT06006000 Evaluating the Unmet Needs of Older Adults to Promote Functional Recovery After a Critical Illness
| NCT ID | NCT06006000 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yale University |
| Condition | Critical Illness |
| Study Type | OBSERVATIONAL |
| Enrollment | 350 participants |
| Start Date | 2024-01-25 |
| Primary Completion | 2028-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 350 participants in total. It began in 2024-01-25 with a primary completion date of 2028-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Lauren Ferrante, MD, MHS
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT06006000 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Critical Illness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06006000 currently recruiting?
Yes, NCT06006000 is actively recruiting participants. Contact the research team at nicole.bouranis@yale.edu for enrollment information.
Where is the NCT06006000 trial being conducted?
This trial is being conducted at New Haven, United States.
Who is sponsoring the NCT06006000 clinical trial?
NCT06006000 is sponsored by Yale University. The principal investigator is Lauren Ferrante, MD, MHS at Yale University. The trial plans to enroll 350 participants.