NCT07616388

Brief Summary

This study aims to develop and test an artificial intelligence (AI) model to predict long-term functional status and return to work after critical illness. The main question is: Can we develop and validate a machine learning model to predict long-term functional status and return to work after critical illness?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,016

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2026

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2026

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 23, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

5 days

First QC Date

May 23, 2026

Last Update Submit

June 6, 2026

Conditions

Keywords

Return to WorkFuncional StatusIntensive CareRecoveryCritical IllnessMachine LearningPost-intensive Care SyndromeCritical Care

Outcome Measures

Primary Outcomes (1)

  • Functional Status

    The primary outcome will be functional status at 6 months after ICU discharge, assessed using the Barthel Index (BI). The BI is a validated measure of functional status in activities of daily living, with total scores ranging from 0 to 100. For prediction modeling, the outcome will be treated as a binary variable, with functional impairment defined as a BI score \<91 points.

    3rd, 6th and 12th months after ICU discharge

Secondary Outcomes (1)

  • Return to Work

    3rd, 6th and 12th months after ICU discharge

Study Arms (1)

Patients in follow-up

Patients under follow-up. No interventions were performed

Other: No interventions were performed.

Interventions

No interventions were performed.

Patients in follow-up

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Ten medical-surgical ICUs representing the five geopolitical regions of Brazil were selected as study sites. This study includes data from two databases with similar inclusion and exclusion criteria.

You may qualify if:

  • Age ≥18 years
  • ICU stay ≥ 72 hours
  • ICU stay ≥ 120 hours if the participant was admitted for elective surgery

You may not qualify if:

  • No telephone contact available
  • Failure to establish contact
  • Transfer to another ICU

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre, Intensive Care Nursing Department

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

MeSH Terms

Conditions

Critical Illnesspostintensive care syndrome

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 23, 2026

First Posted

June 1, 2026

Study Start

March 15, 2026

Primary Completion

March 20, 2026

Study Completion

April 15, 2026

Last Updated

June 10, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations