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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05185674
• Other study ID #: 53543 (Hermes)
• Secondary ID: CEI-2021-06-01
• Status: Completed
• Start date: September 10, 2021
• Est. completion date: May 15, 2022

Study information

• Verified date: September 2022
• Source: Universidad Nacional de Colombia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: May 15, 2022
• Est. primary completion date: April 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Long COVID

Intervention

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

Locations

Country	Name	City	State
Colombia	Hospital Universitario Nacional de Colombia	Bogotá

Sponsors (1)

Lead Sponsor	Collaborator
Javier Eslava

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with new or persistent symptoms after COVID-19 Number of participants with new or persistent symptoms after COVID-19	Percentage of Participants with one or more new or persistent symptoms. Assessment of the presence or absence of one or more new or persistent symptoms after having COVID-19, reported as yes or no for each symptom.; If the participant manifests dyspnea, the severity will be evaluated using the Modified Medical Research Council (mMRC) instrument, with scoring options from 0 to 4. The higher score the worse the symptoms.	Baseline (At the time of the interview and application of the collection instrument)
Primary	Health-related quality of life before and after presenting COVID-19	The instrument 12-Item Short-Form Health Survey (SF-12v2) version in Spanish for Colombia will be applied. The valid questionnaire consists of 12 questions about mental and physical health. Questions will be asked for the current moment and also directed to before having COVID-19. Scores ranging from 0 to 100 with higher score indicating better health.	Baseline (At the time of the interview and application of the collection instrument)
Primary	Health care conditions after presenting COVID-19	The participants will be asked questions designed by the researchers in the collection instrument about medical controls that they have received after medical discharge from COVID-19 and mainly for new or persistent symptoms, reported as yes or no medical control. Frequency of each barrier in access to health services (by default in the collection instrument elaborated by researchers).	Baseline (At the time of the interview and application of the collection instrument)
Primary	Socioeconomic impact after presenting COVID-19	Frequency of each economic impact like salary decrease or job loss. The participants will be asked questions designed by the researchers in the collection instrument about possible personal socioeconomic impacts of having fallen ill with COVID-19 and being admitted to the Intensive Care Unit.	Baseline (At the time of the interview and application of the collection instrument)
Primary	Mental health symptoms before and after presenting COVID-19	The researchers use the valid instrument Self-Reporting Questionnaire (SRQ-20) version in Spanish. The scale consists of 20 questions to be answered: yes or no. The score ranges from 0-20, each positive answer add 1 point. Higher score indicating greater possibility of psychological distress.	Baseline (At the time of the interview and application of the collection instrument)
Primary	Functional Independence before and after presenting COVID-19	The Barthel Index, Spanish version, will be applied to assessment functional independence. Scores ranges from 0 to 100, when 100 is better outcome (independence) and 0 is worst outcome (total dependence).	Baseline (At the time of the interview and application of the collection instrument)