App aims to ease suffering for older ICU patients and their loved ones
NCT ID NCT06588556
First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 2 times
Summary
This study tests a mobile app called ICUconnect that helps older ICU patients and their families report their needs to doctors. The goal is to improve care and reduce emotional distress. About 350 patient-family pairs will take part across four hospitals.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 350 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Patients (who are not interviewed but whose characteristics prompt enrollment of family members) 1. Adult aged ≥18 years 2. Managed in an adult medical, cardiac, trauma, surgical, or neurological ICU 3. Serious acute illness associated with a need for invasive mechanical ventilation 4. ICU team expect patient to require mechanical ventilation for 2 or more days Family members 1. Adult aged ≥18 years 2. Family member: self-described as the individual (related or unrelated) who provides the most support and with whom the eligible patient has a significant relationship (Society of Critical Care Medicine definition of family; Davidson J, et al. Crit Care Med, 45:103-128; 2017) ICU clinicians 1. Adult aged ≥18 years 2. ICU clinician: ICU attending caring for the eligible patient on the day of family member informed consent Exclusion Criteria: Patients 1. Death or full comfort care plan expected within 24 hours by ICU attending or fellow physician Rationale: measurable intervention effect unlikely 2. Palliative care consultative team and/or palliative care specialists are currently involved in the patient's care. Rationale: this would dilute the intervention's effect. 3. ICU length of stay \>4 days during current ICU admission. Rationale: this would dilute intervention effect by widening the timeframe of family-clinician interactions and limiting standardization. 6\. Imprisoned person. Rationale: this is a vulnerable population. Family members 1. Low palliative care need burden (i.e., NEST scale score \<15) at baseline. Rationale: if there are very low baseline needs, the intervention cannot impact the primary outcome measure (i.e., NEST). 2. Lack of English or Spanish fluency, operationalized as need for a translator to understand medical forms or participate in medical discussions. Rationale: the app has not been translated into other languages; also, many outcome measures aren't validated in languages other than English and Spanish. 3. Endorsement of suicidal ideation (i.e., PHQ-9 suicidality item) at the time of baseline data collection. Rationale: this indicates a serious level of distress that will require professional assistance beyond that provided by the intervention (or control). 4. Patient regains decisional capacity after informed consent but before the first family meeting. Rationale: as in our past ICU-based studies, this circumstance (the entry of the patient as a decision maker), would substantially change the nature of the interactions of family members and clinicians. 5. The ICU clinician changes from a consented clinician to a non-consented clinician before the first family meeting. Rationale: in this circumstance the intervention cannot be fully deployed. ICU clinicians None
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Columbia University
RECRUITINGNew York, New York, 10032, United States
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Duke University Medical Center
RECRUITINGDurham, North Carolina, 27710, United States
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Medical University of South Carolina
RECRUITINGCharleston, South Carolina, 29403, United States
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University of Alabama-Birmingham
RECRUITINGBirmingham, Alabama, 35233, United States
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