Quality of Life and Functional Capacity in Post Intensive Care Unit

February 4, 2022 updated by: Matias Bertozzi, Sanatorio Anchorena San Martin

Evolution and Follow-up of the Quality of Life and Functional Capacity, in Patients Admitted in Ward Room, Post-hospitality in the Intensive Care Unit. Descriptive Study

BACKGROUND. Staying in an intensive care unit can lead to physical and cognitive complications and post-traumatic stress. Currently, the aim is to find out the level of quality of life, functional capacity and cognitive status post intensive care unit. Describe the evolution of the quality of life, functional capacity and cognitive status of a cohort of patients admitted to the ward room after discharge from the intensive care unit, with subsequent follow-up at 3, 6 and 12 months of his discharge.

METHODS. Prospective, observational, analytical cohort study. Subjects over 18 years of age with at least 48 hours of confinement in a closed area were included. Demographic variables, quality of life, functional capacity and cognitive status were recorded. A telephone follow-up was carried out three, six and twelve months after institutional discharge. For the evaluation of the primary variables, Euroqol 5d-5L (Eq5d - Eq5d-VAS), Barthel Index and Fototest were used.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

101

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1406
        • Matias Bertozzi

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

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Post ICU patients who entered to the ward room

Description

Inclusion Criteria:

  • All patients over 18 years old
  • At least 48 hours in the ICU
  • Who subsequently entered the Clinical Ward Room
  • Who signed the informed consent

Exclusion Criteria:

  • Those patients who received invasive mechanical ventilation in the last 6 months
  • Who had been admitted to an ICU in the last 6 months
  • Patients who cannot answer the questionnaires on their own or who do not have relatives to answer them
  • Patients with progressive degenerative neurological pathology.
  • Patients diagnosed with cancer with a life expectancy of less than 12 months according to the criteria of the oncologist.

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

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 2019 - 2020
It is the perception that an individual has of his place in existence, in the context of the culture and the value system in which he lives. This aspect was evaluated using the EuroQol Group EQ-5D-5L (EQ-5D-5L) tool.
2019 - 2020
Functional capacity
Time Frame: 2019 - 2020
Functional capacity refers to the capability of performing tasks and activities that people find necessary or desirable in their lives. It was assessed using the Barthel Index (IB) tool.
2019 - 2020
Cognitive status
Time Frame: 2019 - 2020
Cognitive impairment is when a person has trouble remembering, learning new things, concentrating, or making decisions that affect their everyday life.. It was evaluated by Fototest, it is a cognitive test, which includes several domains, language (denomination), executive tasks (verbal fluency) and episodic memory either free or facilitated by keys.
2019 - 2020

Collaborators and Investigators

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

Sponsor

Sanatorio Anchorena San Martin

Collaborators

Cagide Sabrina
Di giorgio Victoria
Villalba Dario
Accoce Matias

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

August 1, 2019

Primary Completion (ACTUAL)

September 30, 2019

Study Completion (ACTUAL)

March 31, 2020

Study Registration Dates

First Submitted

November 9, 2021

First Submitted That Met QC Criteria

November 24, 2021

First Posted (ACTUAL)

December 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 23, 2022

Last Update Submitted That Met QC Criteria

February 4, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • SAnchorenaSanMartin

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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