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

NCT06674603 | Enrolling By Invitation

• 1 other identifier: gzwkj2024-253
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cognition Disorder; ICU; Delirium

Keywords

ICU; delirium; cognition

Outcome Measures

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.

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

Secondary Outcomes (2)

• Hospital Anxiety and Depression Scale (HADS)

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

• Pittsburgh sleep quality index

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

Study Arms (1)

ICU delirium patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ICU patients

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zunyi Medical College: lead
• Guizhou Nursing Vocational College: collaborator

Study Sites (1)

Affiliated Hospital of Guizhou Vocational Nursing Technology College

Guiyang, Guizhou, 550025, China

Location

Related Publications (1)

• Yang X, Jiang Z, Chen F, Zhang X, Yuan X, Yang Y, Xu N, Li S. Trajectory and risk factors of cognitive level in ICU delirium patients after transfer out of the ICU: a protocol for a prospective cohort study. BMJ Open. 2025 Aug 12;15(8):e094232. doi: 10.1136/bmjopen-2024-094232.

  PMID: 40803734 DERIVED

MeSH Terms

Conditions

Cognition Disorders; Delirium

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: researcher

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: November 5, 2024
• Study Start: September 30, 2024
• Primary Completion: March 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: December 16, 2024

Record last verified: 2024-09

Locations

CN (1)