ICU DeliriummHelp@ICUNCT06054828
Modified Hospital Elder Life Program at Intensive Care Unit
A study testing mHELP@ICU in people with ICU Delirium, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU Delirium
- What is being tested?
- mHELP@ICU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Sep 2023to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- participants who are placed on droplet or contact precautions (e.g., Open TB, SARS, COVID-19 )
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Cheryl, Chia-Hui Chen, PhD
Taipei, National Taiwan University, 10055
Chen Chia-Hui, PhD, +886-2-23123456 ext. 288438, cherylchen@ntu.edu.tw
About this study
Official title: 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.
- Conditions
- ICU Delirium
- Being tested
- mHELP@ICU
- Keywords
- Delirium, Intensive care units, Intervention, Mortality, Mobility, Cognitive function, Stepped-wedge cluster randomized controlled trial
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHELP@ICUBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| mHELP@ICU | Experimental | 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. Receives: Behavioral: mHELP@ICU |
| Control group | No intervention | Participants in the control group will receive the usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ICU delirium
Delirium (yes/no) using ICDSC will be abstracted from medical records.
Measured: Admitted to ICU for 14 days
ICU delirium days
Delirium (yes/no) using ICDSC will be abstracted from medical records.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Admitted to ICU for 14 days
Mortality
Data will be obtained from medical records or participants' families.
Measured: Admitted to ICU for 90 days
Length of hospital stay
Data will be obtained from medical records.
Measured: At hospital discharge
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Randomly select four days per week to verify the accuracy of ICDSC data during the first three months of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start5 Sep 2023
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for ICU DeliriumStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054828
- Sponsor's protocol ID
- 202301153RINB
- Acronym
- mHelp@ICU
- Status last verified
- Oct 2025
- First submitted
- 8 Aug 2023
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.
PubMed 15082703Yamamoto T, Mizobata Y, Kawazoe Y, Miyamoto K, Ohta Y, Morimoto T, Yamamura H. Incidence, risk factors, and outcomes for sepsis-associated delirium in patients with mechanical ventilation: A sub-analysis of a multicenter randomized controlled trial. J Crit Care. 2020 Apr;56:140-144. doi: 10.1016/j.jcrc.2019.12.018. Epub 2019 Dec 24.
PubMed 31901649Fiest KM, Soo A, Hee Lee C, Niven DJ, Ely EW, Doig CJ, Stelfox HT. Long-Term Outcomes in ICU Patients with Delirium: A Population-based Cohort Study. Am J Respir Crit Care Med. 2021 Aug 15;204(4):412-420. doi: 10.1164/rccm.202002-0320OC.
PubMed 33823122Lat I, McMillian W, Taylor S, Janzen JM, Papadopoulos S, Korth L, Ehtisham A, Nold J, Agarwal S, Azocar R, Burke P. The impact of delirium on clinical outcomes in mechanically ventilated surgical and trauma patients. Crit Care Med. 2009 Jun;37(6):1898-905. doi: 10.1097/CCM.0b013e31819ffe38.
PubMed 19384221Pandharipande PP, Girard TD, Jackson JC, Morandi A, Thompson JL, Pun BT, Brummel NE, Hughes CG, Vasilevskis EE, Shintani AK, Moons KG, Geevarghese SK, Canonico A, Hopkins RO, Bernard GR, Dittus RS, Ely EW; BRAIN-ICU Study Investigators. Long-term cognitive impairment after critical illness. N Engl J Med. 2013 Oct 3;369(14):1306-16. doi: 10.1056/NEJMoa1301372.
PubMed 24088092Brummel NE, Girard TD, Ely EW, Pandharipande PP, Morandi A, Hughes CG, Graves AJ, Shintani A, Murphy E, Work B, Pun BT, Boehm L, Gill TM, Dittus RS, Jackson JC. Feasibility and safety of early combined cognitive and physical therapy for critically ill medical and surgical patients: the Activity and Cognitive Therapy in ICU (ACT-ICU) trial. Intensive Care Med. 2014 Mar;40(3):370-9. doi: 10.1007/s00134-013-3136-0. Epub 2013 Nov 21.
PubMed 24257969Balas MC, Pun BT, Pasero C, Engel HJ, Perme C, Esbrook CL, Kelly T, Hargett KD, Posa PJ, Barr J, Devlin JW, Morse A, Barnes-Daly MA, Puntillo KA, Aldrich JM, Schweickert WD, Harmon L, Byrum DG, Carson SS, Ely EW, Stollings JL. Common Challenges to Effective ABCDEF Bundle Implementation: The ICU Liberation Campaign Experience. Crit Care Nurse. 2019 Feb;39(1):46-60. doi: 10.4037/ccn2019927.
PubMed 30710036Kotfis K, Marra A, Ely EW. ICU delirium - a diagnostic and therapeutic challenge in the intensive care unit. Anaesthesiol Intensive Ther. 2018;50(2):160-167. doi: 10.5603/AIT.a2018.0011. Epub 2018 Jun 8.
PubMed 29882581Maldonado JR. Delirium pathophysiology: An updated hypothesis of the etiology of acute brain failure. Int J Geriatr Psychiatry. 2018 Nov;33(11):1428-1457. doi: 10.1002/gps.4823. Epub 2017 Dec 26.
PubMed 29278283Inouye SK, Bogardus ST Jr, Charpentier PA, Leo-Summers L, Acampora D, Holford TR, Cooney LM Jr. A multicomponent intervention to prevent delirium in hospitalized older patients. N Engl J Med. 1999 Mar 4;340(9):669-76. doi: 10.1056/NEJM199903043400901.
PubMed 10053175Hshieh TT, Yang T, Gartaganis SL, Yue J, Inouye SK. Hospital Elder Life Program: Systematic Review and Meta-analysis of Effectiveness. Am J Geriatr Psychiatry. 2018 Oct;26(10):1015-1033. doi: 10.1016/j.jagp.2018.06.007. Epub 2018 Jun 26.
PubMed 30076080American Geriatrics Society. AGS COCARE® . 2022
Ely EW. The ABCDEF Bundle: Science and Philosophy of How ICU Liberation Serves Patients and Families. Crit Care Med. 2017 Feb;45(2):321-330. doi: 10.1097/CCM.0000000000002175.
PubMed 28098628Trogrlic Z, van der Jagt M, Bakker J, Balas MC, Ely EW, van der Voort PH, Ista E. A systematic review of implementation strategies for assessment, prevention, and management of ICU delirium and their effect on clinical outcomes. Crit Care. 2015 Apr 9;19(1):157. doi: 10.1186/s13054-015-0886-9.
PubMed 25888230Zhang S, Han Y, Xiao Q, Li H, Wu Y. Effectiveness of Bundle Interventions on ICU Delirium: A Meta-Analysis. Crit Care Med. 2021 Feb 1;49(2):335-346. doi: 10.1097/CCM.0000000000004773.
PubMed 33332818
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Hospital Elder Life Program at Intensive Care Unit: A Stepped-Wedge Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06054828
- Acronym / sponsor ID
- mHelp@ICU / 202301153RINB
- Conditions
- ICU Delirium
- Keywords
- Delirium, Intensive care units, Intervention, Mortality, Mobility, Cognitive function, Stepped-wedge cluster randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mHELP@ICU | Experimental | Behavioral: mHELP@ICUParticipants 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. |
| Control group | No intervention | –Participants in the control group will receive the usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- participants who are placed on droplet or contact precautions (e.g., Open TB, SARS, COVID-19 )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHELP@ICUThe 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. | Behavioural | mHELP@ICU |
Primary outcome
Incidence of ICU delirium
Time frame: Admitted to ICU for 14 days
Delirium (yes/no) using ICDSC will be abstracted from medical records.
ICU delirium days
Time frame: Admitted to ICU for 14 days
Delirium (yes/no) using ICDSC will be abstracted from medical records.
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.
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.
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.
Mortality
Time frame: Admitted to ICU for 90 days
Data will be obtained from medical records or participants' families.
Length of hospital stay
Time frame: At hospital discharge
Data will be obtained from medical records.
7 secondary outcomes
Medical Research Council (MRC) score
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)
Time frame: 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.
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.
Montreal Cognitive Assessment (MoCA)
Time frame: 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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Background: PubMed 15082703Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.
- Background: PubMed 31901649Yamamoto T, Mizobata Y, Kawazoe Y, Miyamoto K, Ohta Y, Morimoto T, Yamamura H. Incidence, risk factors, and outcomes for sepsis-associated delirium in patients with mechanical ventilation: A sub-analysis of a multicenter randomized controlled trial. J Crit Care. 2020 Apr;56:140-144. doi: 10.1016/j.jcrc.2019.12.018. Epub 2019 Dec 24.
- Background: PubMed 33823122Fiest KM, Soo A, Hee Lee C, Niven DJ, Ely EW, Doig CJ, Stelfox HT. Long-Term Outcomes in ICU Patients with Delirium: A Population-based Cohort Study. Am J Respir Crit Care Med. 2021 Aug 15;204(4):412-420. doi: 10.1164/rccm.202002-0320OC.
- Background: PubMed 19384221Lat I, McMillian W, Taylor S, Janzen JM, Papadopoulos S, Korth L, Ehtisham A, Nold J, Agarwal S, Azocar R, Burke P. The impact of delirium on clinical outcomes in mechanically ventilated surgical and trauma patients. Crit Care Med. 2009 Jun;37(6):1898-905. doi: 10.1097/CCM.0b013e31819ffe38.
- Background: PubMed 24088092Pandharipande PP, Girard TD, Jackson JC, Morandi A, Thompson JL, Pun BT, Brummel NE, Hughes CG, Vasilevskis EE, Shintani AK, Moons KG, Geevarghese SK, Canonico A, Hopkins RO, Bernard GR, Dittus RS, Ely EW; BRAIN-ICU Study Investigators. Long-term cognitive impairment after critical illness. N Engl J Med. 2013 Oct 3;369(14):1306-16. doi: 10.1056/NEJMoa1301372.
- Background: PubMed 24257969Brummel NE, Girard TD, Ely EW, Pandharipande PP, Morandi A, Hughes CG, Graves AJ, Shintani A, Murphy E, Work B, Pun BT, Boehm L, Gill TM, Dittus RS, Jackson JC. Feasibility and safety of early combined cognitive and physical therapy for critically ill medical and surgical patients: the Activity and Cognitive Therapy in ICU (ACT-ICU) trial. Intensive Care Med. 2014 Mar;40(3):370-9. doi: 10.1007/s00134-013-3136-0. Epub 2013 Nov 21.
- Background: PubMed 30710036Balas MC, Pun BT, Pasero C, Engel HJ, Perme C, Esbrook CL, Kelly T, Hargett KD, Posa PJ, Barr J, Devlin JW, Morse A, Barnes-Daly MA, Puntillo KA, Aldrich JM, Schweickert WD, Harmon L, Byrum DG, Carson SS, Ely EW, Stollings JL. Common Challenges to Effective ABCDEF Bundle Implementation: The ICU Liberation Campaign Experience. Crit Care Nurse. 2019 Feb;39(1):46-60. doi: 10.4037/ccn2019927.
- Background: PubMed 29882581Kotfis K, Marra A, Ely EW. ICU delirium - a diagnostic and therapeutic challenge in the intensive care unit. Anaesthesiol Intensive Ther. 2018;50(2):160-167. doi: 10.5603/AIT.a2018.0011. Epub 2018 Jun 8.
- Background: PubMed 29278283Maldonado JR. Delirium pathophysiology: An updated hypothesis of the etiology of acute brain failure. Int J Geriatr Psychiatry. 2018 Nov;33(11):1428-1457. doi: 10.1002/gps.4823. Epub 2017 Dec 26.
- Background: PubMed 10053175Inouye SK, Bogardus ST Jr, Charpentier PA, Leo-Summers L, Acampora D, Holford TR, Cooney LM Jr. A multicomponent intervention to prevent delirium in hospitalized older patients. N Engl J Med. 1999 Mar 4;340(9):669-76. doi: 10.1056/NEJM199903043400901.
- Background: PubMed 30076080Hshieh TT, Yang T, Gartaganis SL, Yue J, Inouye SK. Hospital Elder Life Program: Systematic Review and Meta-analysis of Effectiveness. Am J Geriatr Psychiatry. 2018 Oct;26(10):1015-1033. doi: 10.1016/j.jagp.2018.06.007. Epub 2018 Jun 26.
- BackgroundAmerican Geriatrics Society. AGS COCARE® . 2022
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHELP@ICU in people with ICU Delirium, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chen Chia-Hui, PhD (+886-2-23123456 ext. 288438, cherylchen@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ICU delirium (time frame: Admitted to ICU for 14 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06054828, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.