Sociodemographic, Clinical, Quality of Life and Health Care Conditions in COVID-19 Survivors.

Javier Eslava

Status: Completed

Conditions: COVID-19; Post-acute Sequelae of SARS-CoV-2 Infection; Long-COVID; Post-acute COVID-19 Syndrome; Long COVID

Treatments: Other: Exposure: Coronavirus disease 2019 (COVID-19)

Study type: Observational

Funder types: Other

Identifiers

NCT05185674

CEI-2021-06-01 (Other Identifier)

53543 (Hermes)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 114 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

114 participants in 1 patient group

COVID-19 survivors subjects

Description:

All patients discharged from the National University Hospital of Colombia (Bogotá, Colombia) who required admission to the Intensive Care Unit of the same institution with a confirmed diagnosis of SARS-CoV-2 disease (COVID-19 disease) between April 1, 2020 and March 31, 2021 * Severe Acute Respiratory Syndrome (SARS) * Coronavirus (CoV)

Treatment:

Other: Exposure: Coronavirus disease 2019 (COVID-19)