Evaluating the Unmet Needs of Older Adults to Promote Functional Recovery After a Critical Illness
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorYale University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial population
Community-dwelling older adults who return home (either directly or after a stay in short-term rehab (STR)) after an ICU hospitalization.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
350 Participants
are grouped into 1 trial groupGroup A: Older adults returning home post-ICU
Trial outcomes
Primary outcomes
1
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.
Time frame
monthly up to 6 months2
Number of hospital readmissions
Number of hospital readmissions monthly up to 6 months.
Time frame
monthly up to 6 months3
Number of deaths
Number of deaths each month up to 6 months.
Time frame
monthly up to 6 months4
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.
Time frame
month 6Secondary outcomes
1
Functional non-recovery
Not returning to the pre-ICU functional baseline within the follow-up period
Time frame
monthly up to 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov