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

NCT ID: NCT05185674

Last Updated: 2022-09-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 114 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-10
• Study Completion Date: 2022-05-15

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

COVID-19 survivors subjects

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)

Exposure: Coronavirus disease 2019 (COVID-19)

Intervention Type: OTHER

Having presented Coronavirus disease 2019 (COVID-19) and stay in the Intensive Care Unit

Interventions

Exposure: Coronavirus disease 2019 (COVID-19)

Having presented Coronavirus disease 2019 (COVID-19) and stay in the Intensive Care Unit

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Javier Eslava

OTHER

Sponsor Role: lead

Responsible Party

Javier Eslava

Principal Investigator. Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Laura C Loaiza-Fernandez, MD,MSc (c)

Role: PRINCIPAL_INVESTIGATOR

Universidad Nacional de Colombia

Jairo A Pérez-Cely, MD, ICU

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Nacional de Colombia / Universidad Nacional de Colombia

Javier H Eslava-Schamalbach, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Nacional de Colombia / Hospital Universitario Nacional de Colombia

Locations

Hospital Universitario Nacional de Colombia

Bogotá, , Colombia

Countries

Colombia

Other Identifiers

CEI-2021-06-01

Identifier Type: OTHER

Identifier Source: secondary_id

53543 (Hermes)

Identifier Type: -

Identifier Source: org_study_id