Modified Hospital Elder Life Program at Intensive Care Unit (mHelp@ICU)

November 25, 2025 updated by: National Taiwan University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

266

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
    • National Taiwan University
      • Taipei, National Taiwan University, Taiwan, 10055
        • Recruiting
        • Cheryl, Chia-Hui Chen, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 )

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mHELP@ICU
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

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.
No Intervention: Control group
Participants in the control group will receive the usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of ICU delirium
Time Frame: Admitted to ICU for 14 days
Delirium (yes/no) using ICDSC will be abstracted from medical records.
Admitted to ICU for 14 days
ICU delirium days
Time Frame: Admitted to ICU for 14 days
Delirium (yes/no) using ICDSC will be abstracted from medical records.
Admitted to ICU for 14 days
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.
Admitted to ICU for 14 days
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.
Admitted to ICU for 14 days
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.
Admitted to ICU for 14 days
Mortality
Time Frame: Admitted to ICU for 90 days
Data will be obtained from medical records or participants' families.
Admitted to ICU for 90 days
Length of hospital stay
Time Frame: At hospital discharge
Data will be obtained from medical records.
At hospital discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Randomly select four days per week to verify the accuracy of ICDSC data during the first three months of the study.
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.
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)
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.
At baseline (ICU admission); post-ICU 48 hours; day 30 and day 90 since ICU admission.
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.
Post-ICU 48 hours; day 30 and day 90 since ICU admission.
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
At baseline (ICU admission); post-ICU 48 hours; day 30 and day 90 since ICU admission.
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.
Post-ICU 48 hours; day 30 and day 90 since ICU admission.
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.
Post-ICU 48 hours; day 30 and day 90 since ICU admission.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2023

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

August 8, 2023

First Submitted That Met QC Criteria

September 19, 2023

First Posted (Actual)

September 26, 2023

Study Record Updates

Last Update Posted (Actual)

November 28, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202301153RINB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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