Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06006000

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location status: Recruiting

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Disability Count

    Time frame: monthly up to 6 months

    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.

  2. Number of hospital readmissions

    Time frame: monthly up to 6 months

    Number of hospital readmissions monthly up to 6 months.

  3. Number of deaths

    Time frame: monthly up to 6 months

    Number of deaths each month up to 6 months.

  4. Barriers and Facilitators to addressing unmet needs

    Time frame: month 6

    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.

Secondary outcomes

  1. Functional non-recovery

    Time frame: monthly up to 6 months

    Not returning to the pre-ICU functional baseline within the follow-up period

Study contacts

Contact information is provided by the study sponsor or research team.

Nicole Bouranis, PhD

CONTACT

[email protected]

+1 (203) 737-1731

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: LANTERN

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Aug 23, 2023
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.