Funcional StatusNCT07616388
Machine Learning Model for Predicting Recovery After Critical Illness
An observational study of Funcional Status and Return to Work, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Funcional Status, Return to Work, Predictive Learning Models
- How many people
- 2,016 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Mar 2026to 15 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
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.
Who may be able to join
- Age ≥18 years
- ICU stay ≥ 72 hours
- ICU stay ≥ 120 hours if the participant was admitted for elective surgery
Who cannot join
- No telephone contact available
- Failure to establish contact
- Transfer to another ICU
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre, Intensive Care Nursing Department
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Official title: Development and Validation of a Machine Learning Model for Predicting Functional Decline and Return to Work After Critical Illness
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?
Read the detailed description
This is a retrospective observational study using secondary data from two primary studies conducted between 2017-2019 and 2020-2022. No new participants will be recruited. Data were combined and harmonized for the present secondary analysis.
- Conditions
- Funcional Status, Return to Work, Predictive Learning Models
- Being tested
- No interventions were performed.
- Keywords
- Return to Work, Funcional Status, Intensive Care, Recovery, Critical Illness, Machine Learning, Post-intensive Care Syndrome, Critical Care
- Medical subject headings
- Critical Illness, postintensive care syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventions were performed.Other
No interventions were performed.
| Study group | Role | What they receive |
|---|---|---|
| Patients in follow-up | Patients under follow-up. No interventions were performed Receives: Other: No interventions were performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3rd, 6th and 12th months after ICU discharge
Secondary outcomes (1)
Return to Work
Being employed
Measured: 3rd, 6th and 12th months after ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start15 Mar 2026
- Primary completion20 Mar 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Funcional StatusStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,016 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul, Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
- Responsible party
- Principal investigator, Karina De Oliveira Azzolin, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616388
- Sponsor's protocol ID
- 20250554
- Status last verified
- Jun 2026
- First submitted
- 23 May 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Machine Learning Model for Predicting Functional Decline and Return to Work After Critical Illness
- ClinicalTrials.gov ID
- NCT07616388
- Acronym / sponsor ID
- 20250554
- Conditions
- Funcional Status, Return to Work, Predictive Learning Models
- Keywords
- Return to Work, Funcional Status, Intensive Care, Recovery, Critical Illness, Machine Learning, Post-intensive Care Syndrome, Critical Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,016 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul, Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
- Study start
- 15 Mar 2026 (actual)
- Primary completion
- 20 Mar 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 1 Jun 2026 (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.
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?
Detailed description
This is a retrospective observational study using secondary data from two primary studies conducted between 2017-2019 and 2020-2022. No new participants will be recruited. Data were combined and harmonized for the present secondary analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients in follow-up | – | Other: No interventions were performed.Patients under follow-up. No interventions were performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age ≥18 years
- ICU stay ≥ 72 hours
- ICU stay ≥ 120 hours if the participant was admitted for elective surgery
Key exclusion criteria (3 listed)
- No telephone contact available
- Failure to establish contact
- Transfer to another ICU
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 |
|---|---|---|
| No interventions were performed.No interventions were performed. | Other | Patients in follow-up |
Primary outcome
Functional Status
Time frame: 3rd, 6th and 12th months after ICU discharge
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.
1 secondary outcome
Return to Work
Time frame: 3rd, 6th and 12th months after ICU discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Funcional Status and Return to Work, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 3 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: finished, as of the sponsor's last update on 10 Jun 2026. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Status (time frame: 3rd, 6th and 12th months after ICU discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2026.