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

NCT05185674 | Completed

• 2 other identifiers: 53543 (Hermes)CEI-2021-06-01
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (6)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (1)

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)

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

Interventions

Exposure: Coronavirus disease 2019 (COVID-19) OTHER

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

COVID-19 survivors subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Javier Eslava: lead

Study Sites (1)

Hospital Universitario Nacional de Colombia

Bogotá, 111321, Colombia

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; COVID-19; Psychological Well-Being

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior

Study Officials

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

  Universidad Nacional de Colombia

  PRINCIPAL INVESTIGATOR

• Jairo A Pérez-Cely, MD, ICU

  Hospital Universitario Nacional de Colombia / Universidad Nacional de Colombia

  PRINCIPAL INVESTIGATOR

• Javier H Eslava-Schamalbach, MD, PhD

  Universidad Nacional de Colombia / Hospital Universitario Nacional de Colombia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator. Professor

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: January 11, 2022
• Study Start: September 10, 2021
• Primary Completion: April 29, 2022
• Study Completion: May 15, 2022
• Last Updated: September 27, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)