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NCT06588556 · ClinicalTrials.gov registry record · NA

Improving Needs Among Older Adults

A NA study of Critical Illness and Older Adults, sponsored by Duke University.

Recruiting
Registry status
NA
Development phase
350
Enrollment target
4
Study locations

NCT06588556 is a NA study of Critical Illness and Older Adults that is actively recruiting participants, run by Duke University. The registered enrollment target is 350 participants, below the 3,135-participant average among 91 other Critical Illness trials with a reported enrollment target (89% lower). The trial reports 4 study locations across 4 states.

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The verdict

NCT06588556, a NA study of Critical Illness and Older Adults, is actively recruiting participants, sponsored by Duke University.

RECRUITING
Registry status
NA
Development phase
350 participants
Enrollment target
4
Study locations

Study Summary

Millions of older adults receive care in intensive care units (ICUs) annually. However, the quality and accessibility of ICU-based palliative care is highly variable across hospitals and clinicians, due in part to specialists' limited workforce and geographic inconsistency. To address these gaps, the investigators developed an innovative mobile app-based primary palliative care intervention called ICUconnect. ICUconnect facilitates families' and patients' self-report of actual palliative care needs across all core domains of palliative care quality, provides ICU clinicians with a scalable digital infrastructure for coordinating consistent and personalized needs-targeted care, and provides a variety of informational supports relevant to each user's role. In this RCT, the investigators will test ICUconnect vs. usual care control among 350 patient-family member dyads with elevated baseline levels of unmet palliative care need in a 4-site network serving a diverse population (Duke, Medical University of South Carolina, University of Alabama at Birmingham, Columbia). The specific aims are to: (1) Test the efficacy of ICUconnect vs. usual care control in improving palliative care needs and other person-centered outcomes including psychological distress, (2) Determine participant characteristics associated with a greater treatment response using a heterogeneity of treatment effects approach, and (3) Ensure off-the-shelf intervention readiness for implementation using a mixed-methods integration of qualitative analysis of semi-structured trial participant interviews and quantitative RE-AIM implementation framework-informed trial data.

Interventions

  • BEHAVIORAL ICUconnect
  • OTHER Usual care

Study Locations (4)

Alabama

  • University of Alabama-Birmingham - Birmingham

New York

  • Columbia University - New York

North Carolina

  • Duke University Medical Center - Durham

South Carolina

  • Medical University of South Carolina - Charleston

Trial Details

FieldValue
Enrollment Target 350 participants
Start Date 2025-09-16
Est. Completion 2028-12-31
Phase NA

Sponsor

Duke University

1,725 total trials

What the Registry Record Tells You About NCT06588556

The ClinicalTrials.gov registry entry for NCT06588556 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 350 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,135-participant average among 91 other Critical Illness trials with a reported enrollment target (89% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.

The record links to 5 conditions, with Critical Illness appearing as the primary indexed condition, and to 2 interventions - of which ICUconnect is the first listed.

NCT06588556 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Alabama, New York, North Carolina.

Frequently Asked Questions

What is clinical trial NCT06588556 about?

NCT06588556 is a clinical study titled "Improving Needs Among Older Adults". Millions of older adults receive care in intensive care units (ICUs) annually. However, the quality and accessibility of ICU-based palliative care is highly variable across hospitals and clinicians, due in part to specialists' limited workforce and geographic inconsistency. To address these gaps, th...

What is the current status of trial NCT06588556?

This trial is currently recruiting. It is a NA study. The enrollment target is 350 participants. The study started on 2025-09-16. Estimated completion is 2028-12-31.

What conditions does trial NCT06588556 study?

This clinical trial studies the following conditions: Critical Illness, Older Adults, Palliative Care, Informal Caregivers, Care Delivery Model.

What interventions are being tested in trial NCT06588556?

The interventions under investigation include: ICUconnect (BEHAVIORAL), Usual care (OTHER).

Who is sponsoring clinical trial NCT06588556?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06588556 being conducted?

This trial has 4 study locations across Alabama, New York, North Carolina, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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