NCT06054828 Modified Hospital Elder Life Program at Intensive Care Unit
| NCT ID | NCT06054828 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Taiwan University Hospital |
| Condition | ICU Delirium |
| Study Type | INTERVENTIONAL |
| Enrollment | 266 participants |
| Start Date | 2023-09-05 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 266 participants in total. It began in 2023-09-05 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Delirium, a form of acute brain dysfunction, occurs in up to 81% of patients receiving mechanical ventilation in the intensive care unit (ICU). Delirium occurring in the ICU is associated with increased functional dependency, cognitive impairment, longer length of hospital stay, and mortality. This study aim to develop a nursing-driven ICU delirium intervention to reduce incidence of delirium, increase the delirium-and coma-free days (DCFDs), and improve ICU patients' function, cognition, and mortality outcomes 3 months following their ICU admission. The "modified Hospital Elder life Program at the ICU (mHELP@ICU)" will be provided to ensure critically ill patients are cognitively engaged, physically active, and nutritionally well-fed. This three-year study is divided into two phases. The first phase aims to ensure the accuracy of delirium assessment using the Intensive Care Delirium Screening Checklist (ICDSC) by ICU nurses of three participating ICUs. The ICDSC records assessed by ICU nurses will be abstracted from medical records and compared with a gold standard ICDSC evaluation by a well-trained, independent assessor. Cohen's kappa will be reported to represent the consistency of the ICDSC assessment between delirium data from medical records and the independent assessor. When the Cohen's kappa is less than 0.8, a 3-month bedside teaching and real-time feedback education program will be implemented at three ICU units to improve the accuracy of ICDSC assessment by ICU nurses. The second phase will be a clinical trial using a stepped-wedge cluster randomized controlled trial design. Adult (18 years and older) critically ill patients receiving mechanical ventilation will be consecutively enrolled from three mix-medical ICUs at a studied medical center. Estimated 266 participants will be cluster-randomized into the intervention and control groups. Participants in the intervention group will receive a 14-day mHELP@ICU, provided by a trained mHELP nurse, while the participants who received the usual care will serve as controls. Effects of mHELP@ICU will be evaluated using the daily delirium and coma data (max 14 days, or until death or ICU discharge) retrieved from the medical records, along with the participants' mortality, cognitive, and functional outcomes, which a blinded outcome assessor will assess at 48 hours, 14 days, 30 days, and 90 days after ICU admission.
Eligibility Criteria
Inclusion Criteria of the second phase * participants who are 18 years old or older. * participants who receive oral endotracheal intubation with mechanical ventilation and are expected intubation greater than 48 hours. * participants are free from delirium or coma before ICU admission. Exclusion Criteria of the second phase * participants who are placed on droplet or contact precautions (e.g., Open TB, SARS, COVID-19 )
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06054828 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying ICU Delirium. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06054828 currently recruiting?
Yes, NCT06054828 is actively recruiting participants. Contact the research team at cherylchen@ntu.edu.tw for enrollment information.
Where is the NCT06054828 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT06054828 clinical trial?
NCT06054828 is sponsored by National Taiwan University Hospital. The trial plans to enroll 266 participants.