An interventional study of mHELP@ICU in ICU Delirium, sponsored by National Taiwan University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-28.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
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.
1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.
This study's planned enrollment of 266 is above the median of 120 across 599 interventional studies indexed under Delirium.
Browse Delirium studies →National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria of the second phase
Participants will receive cognitive engagement twice daily, have physical activity once daily, and be monitored for their feeding. The intervention will be administered for 14 days or until hospital discharge or death.
Behavioral: mHELP@ICU
Participants in the control group will receive the usual care.
The 14-day mHELP@ICU consists of the following three components: 1. Cognitive engagement twice daily: Participants will receive orienting communication, plus one of the following training on attention, memory, or function execution. 2. Physical activity once daily: Participants will receive a passive range of motion(ROM) and/or anti-gravity ROM exercise if tolerated. 3. Feeding monitor daily: The exact feeding data will be abstracted from medical records.
Incidence of ICU delirium
Delirium (yes/no) using ICDSC will be abstracted from medical records.
Time frame: Admitted to ICU for 14 days
ICU delirium days
Delirium (yes/no) using ICDSC will be abstracted from medical records.
Time frame: Admitted to ICU for 14 days
Incidence of ICU coma
Coma (yes/no) defined by RASS score of -4 or -5 will be abstracted from medical records.
Time frame: Admitted to ICU for 14 days
ICU coma days
Coma (yes/no) defined by RASS score of -4 or -5 will be abstracted from medical records.
Time frame: Admitted to ICU for 14 days
Days of delirium- and coma-free days (DCFDs)
DCFDs (yes/no) are defined as the number of days during the study period during which the patient was alive without delirium or coma associated with any cause and obtained.
Time frame: Admitted to ICU for 14 days
Mortality
Data will be obtained from medical records or participants' families.
Time frame: Admitted to ICU for 90 days
Length of hospital stay
Data will be obtained from medical records.
Time frame: At hospital discharge
Medical Research Council (MRC) score
Participants' muscle strength will be evaluated using the medical research council scale (MRC). Score range from 0 to 60; a higher score indicates better muscle strength.
Time frame: At baseline (ICU admission); post-ICU 48 hours; day 30 and day 90 since ICU admission.
Functional Status Score for the Intensive Care Unit (FSS-ICU)
Participants' functional status will be evaluated using the FSS-ICU. Score range from 0 to 35, a higher score indicates better functional status.
Time frame: At baseline (ICU admission); post-ICU 48 hours; day 30 and day 90 since ICU admission.
30-second sit-to-stand test
Participants will be asked for sit-to-stand repeatedly for 30 seconds.
Time frame: Post-ICU 48 hours; day 30 and day 90 since ICU admission.
Barthel index for activities of daily living (ADL)
Measured by ADL in score, range from 0-100 score, higher score indicated health condition
Time frame: At baseline (ICU admission); post-ICU 48 hours; day 30 and day 90 since ICU admission.
Montreal Cognitive Assessment (MoCA)
Participants' cognitive function will be evaluated using th MoCA. Score range from 0-30 score, higher than 23.5 scores indicates normal cognitive.
Time frame: Post-ICU 48 hours; day 30 and day 90 since ICU admission.
Color Trails Test (CTT)
Participants' visual attention and effortful executive processing abilities will be evaluated using the CTT; the time taken to complete each part of the CTT is recorded in seconds and is compared to normative data.
Time frame: Post-ICU 48 hours; day 30 and day 90 since ICU admission.
Accuracy rate of ICDSC data (yes/no)
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.
Time frame: Randomly select four days per week to verify the accuracy of ICDSC data during the first three months of the study.
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National Taiwan University Hospital