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NCT Number: NCT06054828

Modified Hospital Elder Life Program at Intensive Care Unit

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cheryl, Chia-Hui Chen, PhD

Taipei, National Taiwan University, 10055, Taiwan

Location status: Recruiting

Location contact

Chen Chia-Hui, PhD

CONTACT

[email protected]

+886-2-23123456 ext. 288438

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 )

Treatment and study plan

mHELP@ICU

Behavioral

The 14-day mHELP@ICU consists of the following three components:

  • Cognitive engagement twice daily: Participants will receive orienting communication, plus one of the following training on attention, memory, or function execution.
  • Physical activity once daily: Participants will receive a passive range of motion(ROM) and/or anti-gravity ROM exercise if tolerated.
  • Feeding monitor daily: The exact feeding data will be abstracted from medical records.

Primary outcomes

  1. Incidence of ICU delirium

    Time frame: Admitted to ICU for 14 days

    Delirium (yes/no) using ICDSC will be abstracted from medical records.

  2. ICU delirium days

    Time frame: Admitted to ICU for 14 days

    Delirium (yes/no) using ICDSC will be abstracted from medical records.

  3. Incidence of ICU coma

    Time frame: Admitted to ICU for 14 days

    Coma (yes/no) defined by RASS score of -4 or -5 will be abstracted from medical records.

  4. ICU coma days

    Time frame: Admitted to ICU for 14 days

    Coma (yes/no) defined by RASS score of -4 or -5 will be abstracted from medical records.

  5. Days of delirium- and coma-free days (DCFDs)

    Time frame: Admitted to ICU for 14 days

    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.

  6. Mortality

    Time frame: Admitted to ICU for 90 days

    Data will be obtained from medical records or participants' families.

  7. Length of hospital stay

    Time frame: At hospital discharge

    Data will be obtained from medical records.

Secondary outcomes

  1. Medical Research Council (MRC) score

    Time frame: At baseline (ICU admission); post-ICU 48 hours; day 30 and day 90 since ICU admission.

    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.

  2. Functional Status Score for the Intensive Care Unit (FSS-ICU)

    Time frame: At baseline (ICU admission); post-ICU 48 hours; day 30 and day 90 since ICU admission.

    Participants' functional status will be evaluated using the FSS-ICU. Score range from 0 to 35, a higher score indicates better functional status.

  3. 30-second sit-to-stand test

    Time frame: Post-ICU 48 hours; day 30 and day 90 since ICU admission.

    Participants will be asked for sit-to-stand repeatedly for 30 seconds.

  4. Barthel index for activities of daily living (ADL)

    Time frame: At baseline (ICU admission); post-ICU 48 hours; day 30 and day 90 since ICU admission.

    Measured by ADL in score, range from 0-100 score, higher score indicated health condition

  5. Montreal Cognitive Assessment (MoCA)

    Time frame: Post-ICU 48 hours; day 30 and day 90 since ICU admission.

    Participants' cognitive function will be evaluated using th MoCA. Score range from 0-30 score, higher than 23.5 scores indicates normal cognitive.

  6. Color Trails Test (CTT)

    Time frame: Post-ICU 48 hours; day 30 and day 90 since ICU admission.

    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.

  7. Accuracy rate of ICDSC data (yes/no)

    Time frame: Randomly select four days per week to verify the accuracy of ICDSC data during the first three months of the study.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chen Chia-Hui, PhD

CONTACT

[email protected]

+886-2-23123456 ext. 288438

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Modified Hospital Elder Life Program at Intensive Care Unit: A Stepped-Wedge Cluster Randomized Controlled Trial

Acronym: mHelp@ICU

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 26, 2023
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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