Critical IllnessLANTERNNCT06006000
Evaluating the Unmet Needs of Older Adults to Promote Functional Recovery After a Critical Illness
An observational study of Critical Illness and Illness, Critical, run by Yale University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Critical Illness, Illness, Critical
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2024to Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Community-dwelling older adults who return home (either directly or after a stay in short-term rehab (STR)) after an ICU hospitalization.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yale New Haven Hospital
New Haven, Connecticut, 06520
About this study
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.
Read the detailed description
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
- Critical Illness, Illness, Critical
- Keywords
- Geriatrics, Older Adults
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: monthly up to 6 months
Number of hospital readmissions
Number of hospital readmissions monthly up to 6 months.
Measured: monthly up to 6 months
Number of deaths
Number of deaths each month up to 6 months.
Measured: monthly up to 6 months
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.
Measured: month 6
Secondary outcomes (1)
Functional non-recovery
Not returning to the pre-ICU functional baseline within the follow-up period
Measured: monthly up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start25 Jan 2024
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Lauren Ferrante, MD, MHS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06006000
- Sponsor's protocol ID
- 2000034943
- Other IDs
- 1R01AG079916-01A1
- Acronym
- LANTERN
- Status last verified
- Jun 2026
- First submitted
- 15 Aug 2023
- Last updated
- 17 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data from this study will be available to investigators who sign a Data Use Agreement (DUA) executed between Yale University and the investigator's institution. The DUA requires the investigators to attest to (1) their commitment to using the data only for approved research purposes and not to identify any individual human participant; (2) their commitment to securing the data using appropriate computer technology; and (3) their commitment to destroying or returning the data after analyses are completed. Data will not be available until all analyses are complete.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Unmet Needs of Older Adults to Promote Functional Recovery After a Critical Illness
- ClinicalTrials.gov ID
- NCT06006000
- Acronym / sponsor ID
- LANTERN / 2000034943
- Conditions
- Critical Illness, Illness, Critical
- Keywords
- Geriatrics, Older Adults
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Community-dwelling older adults who return home (either directly or after a stay in short-term rehab (STR)) after an ICU hospitalization.
Key inclusion criteria (6 listed)
- PARTICIPANTS
- Age ≥ 65 years
- Survived an ICU admission of ≥2 days
- CAREGIVERS
- Age ≥ 18 years
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Number of hospital readmissions
Time frame: monthly up to 6 months
Number of hospital readmissions monthly up to 6 months.
Number of deaths
Time frame: monthly up to 6 months
Number of deaths each month up to 6 months.
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.
1 secondary outcome
Functional non-recovery
Time frame: monthly up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: Yes. Deidentified data from this study will be available to investigators who sign a Data Use Agreement (DUA) executed between Yale University and the investigator's institution. The DUA requires the investigators to attest to (1) their commitment to using the data only for approved research purposes and not to identify any individual human participant; (2) their commitment to securing the data using appropriate computer technology; and (3) their commitment to destroying or returning the data after analyses are completed. Data will not be available until all analyses are complete.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lauren Ferrante, MD, MHS principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Illness, Critical, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Bouranis, PhD (+1 (203) 737-1731, nicole.bouranis@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability Count (time frame: monthly up to 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.