Clinical trial NCT05185674: Sociodemographic, Clinical, Quality of Life and Health Care Conditions in COVID-19 Survivors.
Official title: Sociodemographic,Clinical,Quality of Life, and Health Care Conditions After Hospital Discharge in Patients Who Required Admission to ICU for COVID-19 at Hospital Universitario Nacional Between April 2020 and March 2021. Bogotá, Colombia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-acute COVID-19 Syndrome
Long-COVID
COVID-19
Long COVID
Post-acute Sequelae of SARS-CoV-2 Infection
Keywords: Sequelae
Quality of Life
Delivery of Health Care
Socioeconomic factors
Mental health
Functional status
Intensive Care Unit
COVID-19
Post-acute COVID-19 syndrome
Long-COVID
Lead sponsor: Universidad Nacional de Colombia
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: : Patients admitted to the Intensive Care Unit of the Hospital Universitario Nacional de Colombia (Bogotá, Colombia) between April 1, 2020 and March 31, 2021.

Brief summary: Sociodemographic, Clinical, Quality of Life, and Health Care Conditions After Hospital Discharge in Patients Who Required Admission to the Intensive Care Unit for COVID-19 at the Hospital Universitario Nacional Between April 2020 and March 2021. Bogotá, Colombia

The main objective of this study is to characterize the sociodemographic, clinical, quality of life and health care conditions in a cohort of patients who have survived a stay in the Intensive Care Unit of the National University Hospital of Colombia. Secondarily, associations between these findings and sociodemographic and clinical characteristics will be evaluated.

It is expected to contribute to the scientific literature through the characterization and epidemiology of the problem in a sample of patients from a Latin American country. It is planned to contribute not only with clinical data, but also with data on socioeconomic impacts on patients and notions of the health care they are receiving. Through the analyzes to be carried out, associations that will contribute to the evidence for prevention and management of the outcome will be explored.

Detailed description: Progressively, the evidence is growing that COVID-19 survivors present persistent or new symptoms and / or alterations in diagnostic studies / functional tests. There is no consensual characterization and denomination for this outcome, proposing names such as "Long-COVID" or "Post-COVID Syndrome", among others. Nor are there homogeneous estimates regarding incidence and prevalence. Most of the population studies and surveys have been conducted in the United States, China, and European countries. It is considered that this problem can have negative effects on the quality of life, the health of patients and a significant burden of disease for the system. Patients may face inequities and barriers in health care.

At the national and global level; it is projected that large numbers of people may present or are exhibiting this "syndrome." Knowing the situation is necessary to formulate and develop responses in terms of prevention, diagnosis, management and rehabilitation.

This study will be carried out with the main purpose of characterizing the sociodemographic, clinical, quality of life and health care conditions in a cohort of patients who have survived a stay in the Intensive Care Unit of the National University Hospital of Colombia. Secondarily, associations between these findings and sociodemographic and clinical characteristics will be evaluated.

The study will be developed with patients who have been admitted to the Intensive Care Unit of the National University Hospital of Colombia for COVID-19. Once the study is explained to the potential participants, doubts are resolved and informed consent is obtained; clinical variables registered in the database will be taken and a remote interview (virtual, telephone) will be carried out with the participant applying the collection instrument that contains questions of own elaboration and validated and recognized scales. No physical, treatment or experimentation interventions will be made. The study period is from April 1, 2020 to March 31, 2021. A pilot test is included to determine the applicability of the collection instrument, average duration of the interview, feasibility of filling out informed consent by electronic means and disposition of the participants to receive the information and be part of the study.

The data is recorded in REDCap and will be taken to the R-Studio statistical program, through which and with the STATA v16.1 program the analysis will be executed.

As a benefit to patients, a copy of their answers to the instrument's medical questions and a medical guidance will be sent to them. It will be explained to the participants that said orientation does not replace a formal medical consultation nor does it correspond to a teleconsultation and medical orders will not be issued.

This study also corresponds to a Master's thesis in Public Health for the Universidad Nacional de Colombia, within the framework of the "Equidad en Salud" Research Group of the Universidad Nacional de Colombia.

Eligibility criteria: Inclusion Criteria:

* Inclusion Criteria
* Living patients, who presented COVID-19 with admission to the Intensive Care Unit of the National University Hospital of Colombia between April 1, 2020 and March 31, 2021.
* Patients 18 years of age and older
* COVID-19 confirmed by polymerase chain reaction (PCR) test positive for SARS-CoV-19.
* Signature of informed consent

Exclusion Criteria:

* Missing data in the database, referring to the variables of interest
* Pregnant patients
* Limitation for communication in Spanish language

Primary outcomes:
measure: Number of participants with new or persistent symptoms after COVID-19 Number of participants with new or persistent symptoms after COVID-19
timeFrame: Baseline (At the time of the interview and application of the collection instrument)
measure: Health-related quality of life before and after presenting COVID-19
timeFrame: Baseline (At the time of the interview and application of the collection instrument)
measure: Health care conditions after presenting COVID-19
timeFrame: Baseline (At the time of the interview and application of the collection instrument)
measure: Socioeconomic impact after presenting COVID-19
timeFrame: Baseline (At the time of the interview and application of the collection instrument)
measure: Mental health symptoms before and after presenting COVID-19
timeFrame: Baseline (At the time of the interview and application of the collection instrument)
measure: Functional Independence before and after presenting COVID-19
timeFrame: Baseline (At the time of the interview and application of the collection instrument)
Secondary outcomes:
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Hospital Universitario Nacional de Colombia
Study officials:
affiliation: Universidad Nacional de Colombia
name: Laura C Loaiza-Fernandez, MD,MSc (c)
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Nacional de Colombia / Universidad Nacional de Colombia
name: Jairo A Pérez-Cely, MD, ICU
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Nacional de Colombia / Hospital Universitario Nacional de Colombia
name: Javier H Eslava-Schamalbach, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: