Machine Learning-based Longitudinal Study of Post-ICU Syndrome Development Trajectory in Critically Ill Patients and Construction of Clinical Early Warning Models: a Research Protocol for Longitudinal Study

May 26, 2025 updated by: The Affiliated Hospital Of Guizhou Medical University
This project intends to track and evaluate whether post-ICU syndrome will occur 7 days, 1 month, 3 months and 6 months after ICU patients are transferred out of the ICU through a longitudinal study, apply the latent category growth model to identify different trajectory patterns of post-ICU syndrome in critically ill patients, and use modern machine learning models to build an early warning model of the trajectory patterns of post-ICU syndrome.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
840

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guizhou
      • GuiYang, Guizhou, China, 550004
        • Recruiting
        • Affiliated Hospital of Guizhou Medical University
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Stage one involved studying patients discharged from the ICU and their families to investigate the occurrence and factors influencing post-intensive care syndrome (PICS), identifying various developmental patterns of PICS. A minimum sample size of 840 patients and 420 family members was established. Stage two focused on developing and evaluating a machine learning-based early warning model for PICS. The model construction utilized data from stage one, while the evaluation included 525 patients and 393 family members who met the exclusion criteria.

Description

Inclusion Criteria patients :

  • Length of stay in ICU ≥24h;
  • Age ≥18 years old;
  • Conscious when leaving ICU, communicating with investigators without barriers;
  • Informed consent. Family members：
  • One family member ≥18 years of age was selected for each patient;
  • Assume the main role of caring for patients and medical decision-making;
  • No history of mental illness or other serious organic diseases;
  • Informed consent and voluntary participation in this study.

Exclusion Criteria patients :

  • Have been in ICU for more than 24h within 3 months before this admission;
  • Transferred to another ICU;
  • Cognitive impairment existed before ICU admission (BDRS > 4 points);
  • Severe hearing impairment, dysarthria, etc., which cannot be followed up;
  • Unable to complete the questionnaire survey due to serious illness.

Family members:

  • Family members refuse to participate in the study due to their own reasons;
  • Severe hearing and language impairment, unable to cooperate with researchers.

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Correlation scale score
Time Frame: 2024-2026

Patient:

  1. Post-icu syndrome assessment of ICU survivors: Healthy Aging Brain Care monitoring(HABC Monitor) score;
  2. ICU related Memory: Intensive Care Unit Memory Tool (ICUMT);
  3. Sleep quality: Richards-Campbell Sleep Questionnaire (RCSQ);
  4. Perceived Social Support Scale (PSSS).

Family members:

  1. Sleep quality of family members: Richards-Campbell Sleep Questionnaire (RCSQ);
  2. anxiety and Depression of family members: Hospital anxiety and Depression Scale score;
  3. Family fatigue: Scores of fatigue rating Scale;
  4. PTSD of family members: Event Impact Scale score;
2024-2026

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Affiliated Hospital Of Guizhou Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Chinese nursing association

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Li Yao, Affiliated Hospital of Guizhou Medical University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZHKYQ202316
  • No. ZHKYQ202316 (Other Grant/Funding Number: Chinese Nursing Association)
  • No. Gyfynsfc[2023]35 (Other Grant/Funding Number: The Affiliated Hospital of Guizhou Medical University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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