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Enrolling by invitationNCT06674603Updated Dec 16, 2024

The Trajectory and Influencing Factors of Cognitive Level in ICU Delirium Patients After Transfer Out of the ICU

An observational study in Cognition Disorder, ICU and Delirium, sponsored by Zunyi Medical College. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-16.

Sponsored by Zunyi Medical College · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2026, 6 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
240
Ages
18 Years and older
Sex
All
01

Study summary

Introduction:Delirium is a prevalent psychiatric disorder observed in the Intensive Care unit(ICU) hat; often aggravates patients; overall health status, extends the duration of mechanical ventilation, prolongs ICU stays, and causes persistent or long-term cognitive impairment. A plethora of studies have indicated that the frequency, duration, and severity of delirium during hospitalization are significant risk factors for cognitive impairment in patients following transfer from the ICU. However, existing research has predominantly focused on cross-sectional analyses without delving into the influencing factors among patient subgroups. Consequently, the aim of this study is to employ the Latent Growth Curve Model (LGCM) and the Latent Class Growth Model (LCGM) model to analyze the trajectory of cognitive development and influencing factors of patients with delirium in the ICU one year after discharge.

Methods and analysis:This prospective study aims to investigate the trajectory of cognitive level variations of patients with delirium in ICU for one year. It is planned to recruit 240 participants and gather comprehensive data including general demographics, disease-related information, scores from the Minimum Mental State Examination, Hospital Anxiety and Depression Scale, and the Pittsburgh Sleep Quality Index. All data will be followed up using the same schedule on the day of transfer, 1 month after transfer, 3 months after transfer, 6 months after transfer and 1 year after transfer. Ultimately, the investigators will employ Latent Growth Curve Model and Latent Class Growth Model to analyze the trajectory of cognitive changes and identify potential categories, in addition to utilizing logistic regression modeling to explore influencing factors. The results of this study provide a theoretical framework for the clinical implementation of precision nursing interventions within this demographic, so as to prevent and reduce the decline of cognitive function and improve the quality of life of patients.

Read the detailed description

A prospective longitudinal cohort study will be conducted in the ICU of a tertiary grade-A hospital in Guizhou Province. The study aims to recruit 240 patients diagnosed with ICU delirium, who were carefully selected based on predefined inclusion and exclusion criteria (Inclusion and exclusion criteria were as follows). The study is anticipated to commence in September 2024 and conclude in May 2026.

The inclusion criteria are:

  1. Patients diagnosed with delirium by Confusion Assessment Model for Intensive Care Unit.
  2. Age ≥ 18 years old.
  3. Length of stay in ICU ≥24h.
  4. Patients were able to complete the questionnaire by themselves or with the cooperation of their family members.5. Patients or family members gave informed consent and participated in the survey voluntarily.

The exclusion criteria are:

  1. Previously diagnosed with dementia.
  2. Mental illness or history of mental illness.
  3. Suffering from traumatic brain injury, cerebrovascular disease, stroke, cranial surgery, intracranial infections, and other conditions that may affect cognitive function.
  4. Presence of visual, hearing or communication impairments. Collection of general and disease-related information: trained staff assess ICU patients for delirium at the conclusion of the daily shift. Patients with delirium are included in the study, with the severity of delirium evaluated using the confusion assessment method for the ICU-7 scale. The date and time of delirium will be recorded, and the assessment will be carried out on a daily basis until the patient is transferred out of the ICU. Delirium-related information will be compiled after the patient's transfer out, and clinical subphenotypes of delirium will be ascertained using the RASS score , precipitant subphenotypes of delirium based on the patient's symptoms, severity of delirium based on the confusion assessment method for the ICU-7 scale, and the duration and frequency of occurrence of delirium based on the date and time of the recorded tracing. In addition, written informed consent will be obtained from the participants or their families prior to the commencement of data collection.

Follow-up data collection: at the time of patient transfer, the research team remains in contact with the participants and tracks their whereabouts and rehabilitation outcomes after discharge. Follow-up visits are conducted on the day of transfer (T1), 1 month after transfer (T2), 3 months after transfer (T3), 6 months after transfer (T4), and 1 year after transfer (T5) (see Table 4). Members of our study team will provide one-on-one contact with patients via WeChat video or face-to-face follow-up. Participants or family members are deemed disengaged if they are unwilling to cooperate in the study.

Outcome measures: cognitive level, anxiety and depression level and sleep status of delirium patients after discharge. Minimum Mental State Examination, Hospital Anxiety and Depression Scale and Pittsburgh sleep quality index will be used for measurement.

02

Conditions studied

  • Cognition Disorder
  • ICU
  • Delirium

Keywords

  • ICU
  • delirium
  • cognition
03

In context

Delirium

1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.

This study's planned enrollment of 240 is above the median of 200 across 418 observational studies indexed under Delirium.

Browse Delirium studies →

Lead sponsor

Zunyi Medical College is the lead sponsor of 20 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

ICU patients

Eligibility criteria

The inclusion criteria are:

  1. Patients diagnosed with delirium by CAM-ICU.
  2. Age ≥ 18 years old.
  3. Length of stay in ICU ≥24h.
  4. Patients were able to complete the questionnaire by themselves or with the cooperation of their family members.
  5. Patients or family members gave informed consent and participated in the survey voluntarily.

The exclusion criteria are:

  1. Previously diagnosed with dementia.
  2. Mental illness or history of mental illness.
  3. Suffering from traumatic brain injury, cerebrovascular disease, stroke, cranial surgery, intracranial infections, and other conditions that may affect cognitive function.
  4. Presence of visual, hearing or communication impairments.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
240 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • ICU delirium patients
06

What researchers measure

Primary outcomes

  1. cognitive level MMSE scale

    cognitive level will be assessed using the MMSE scale. The scale is designed to assess five aspects, namely orientation, memory, attention and calculation, recall, and language, with a total of score 30 points. The cognitive functioning improves as the score increases, with scores ranging from 27 to 30 being normal, and scores below 27 indicating cognitive dysfunction.The higher the score, the better the cognitive status of patients.

    Time frame: from the day the patient was transferred out of the ICU to the end of the year.

Secondary outcomes

  1. Hospital Anxiety and Depression Scale (HADS)

    The scale is utilized for evaluating the extent of anxiety and depression present in patients.The scale contains 14 entries, including 2 subscales for anxiety and depression, with 7 entries rating depression and 7 entries rating anxiety. The total score of both subscales ranges from 0 to 7 for no anxiety or depression, 8 to 10 for critical anxiety or depression, and 11 to 21 for significant anxiety or depression.

    Time frame: from the day the patient was transferred out of the ICU to the end of the year.

  2. Pittsburgh sleep quality index

    The scale evaluate a patient's quality of sleep in the last month. Each entry was rated on a scale of 0 to 3, summing up to a total score between 0 and 21, where higher scores signify a deterioration in sleep quality.

    Time frame: from the day the patient was transferred out of the ICU to the end of the year.

07

Study locations

1 site
  • Affiliated Hospital of Guizhou Vocational Nursing Technology College
    Guiyang, Guizhou 550025, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06674603
Lead sponsor
Zunyi Medical College
Collaborators
Guizhou Nursing Vocational College
Responsible party
Yang Xia (researcher, Zunyi Medical College) — Principal investigator
First posted
Nov 5, 2024
Start date
Sep 30, 2024
Primary completion
Mar 30, 2026 (estimated)
Completion
May 30, 2026 (estimated)
Last update
Dec 16, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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