Cohort Study for the Assessment of Long-term Impact of COVID-19 Among Moderate and Severe COVID-19 Patients in Brazil

Active, not recruiting

• Conditions: COVID-19; Disability Physical; Disabilities Mental; Quality of Life
• Interventions: Other: Hospitalization due to COVID-19

• Registration Number: NCT05165979
• Lead Sponsor: Hospital Moinhos de Vento

Brief Summary

The present prospective cohort study aims to assess factors associated with of one-year health-related quality of life and physical, cognitive and mental health outcomes among adult survivors of hospitalization for COVID-19. Adult patients requiring hospitalization due to COVID-19 disease will be followed through structured and centralized telephone interviews performed at 3, 6, 9 and 12 months after enrollment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-20
• Study First Submitted QC: 2021-12-20
• Study Start: 2021-12-21
• Study First Posted: 2021-12-21
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-03
• Last Update Posted: 2023-11-07
• Primary Completion: 2024-04-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 650

Inclusion Criteria

• Age ≥18 years;
• Symptomatic COVID-19 disease within the last 14 days;
• Positive polymerase chain reaction (PCR) test for SARS-CoV-2 within the last 14 days;
• Need of hospitalization (duration ≥ 48 hours).

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Exclusion Criteria

• Severe comorbidity with life expectancy less than 3 months;
• Death during hospitalization;
• Absence of telephone contact;
• Absence of proxy for patients with communication difficulties;
• Refusal or withdrawal of agreement to participate;
• Previous enrollment in the study.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hospitalized COVID-19 patients	Hospitalization due to COVID-19	Hospitalized COVID-19 patients

Primary Outcome Measures

Name	Time	Method
One-year utility score of health related quality of life	The outcome will be assessed 12 months after enrollment.	The outcome will be assessed using the Brazilian version of the Euroqol-5D-3L (EQ-5D3L) questionnaire.

Secondary Outcome Measures

Name	Time	Method
Instrumental Activities of Daily Living	The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.	The outcome will be assessed using the Lawton \& Brody Instrumental Activities of Daily Living Scale (the score ranges from 0 to 8, with higher scores indicating less dependence).
Utility score of health related quality of life at 3, 6, and 9 months	The outcome will be assessed at 3, 6, and 9 months after enrollment.	The outcome will be assessed using the Brazilian version of the Euroqol-5D-3L (EQ-5D3L) questionnaire. The utility score derived from the EQ5D-3L ranges from 0 (death) to 1 (perfect health).
Incidence of major cardiovascular events	The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.	Incidence of major cardiovascular events (composite endpoint of non-fatal stroke, non-fatal acute myocardial infarction, or cardiovascular death)
Prevalence of anxiety and depression symptoms	The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.	Prevalence of anxiety and depression symptoms as assessed by the Hospital Anxiety and Depression Scale (anxiety and depression scores range from 0 to 21, with higher scores indicating worse symptoms).
Incidence of rehospitalizations	The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.	Incidence of all-cause rehospitalizations
Prevalence of prolonged COVID-19 symptoms	The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.	Prevalence of prolonged COVID-19 symptoms defined as presence of dyspnea, cough, fatigue, muscular weakness, chest discomfort, joint pain, anosmia, hair loss, brain fog, insomnia, among others)
Prevalence of posttraumatic stress disorder symptoms	The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.	Prevalence of posttraumatic stress disorder symptoms as assessed by the Impact Event Scale-6 (scores range from 0 to 24 with higher scores indicating worse symptoms).
Incidence of return to work or study	The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.	Incidence of return to work or study among patients that were working or studying at the moment of hospitalization.
Incidence of all-cause mortality	The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.	Incidence of all-cause mortality
Prevalence of cognitive dysfunction	The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.	Prevalence of cognitive dysfunction as assessed by the Telephone Interview for Cognitive Status (TICS-m; scores ranging from 0 to 50 with lower scores indicating worse cognition).
Incidence of new symptomatic COVID-19 infection	The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.	Incidence of new symptomatic COVID-19 infection defined as recurrence of COVID-19-related symptoms with a positive PCR test for SARS-CoV-2 90 days after the index infection.
Physical functional status	The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.	Physical functional status as assessed by the modified Barthel index (score ranges from 0 to 100; higher scores indicate less functional dependence).

Trial Locations

Locations (24)

Hospital moinhos de Vento; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Cemetron; 🇧🇷 Porto Velho, RO, Brazil

Hospital Universitário de Canoas; 🇧🇷 Canoas, RS, Brazil

Hospital Leo Orsi; 🇧🇷 Itapetininga, SP, Brazil

Hospital das clínicas da UFMG; 🇧🇷 Belo Horizonte, MG, Brazil

Hospital Emydio Germano; 🇧🇷 Belo Horizonte, MG, Brazil

Hospital das Clínicas de Passo Fundo; 🇧🇷 Passo Fundo, RS, Brazil

Hospital Beneficência Portuguesa de São Paulo; 🇧🇷 São Paulo, SP, Brazil

Hospital Metropolitano Célio de Castro; 🇧🇷 Belo Horizonte, MG, Brazil

Hospital do Coração de Mato Grosso do Sul; 🇧🇷 Campo Grande, MS, Brazil

Hospital Ernesto Dornelles; 🇧🇷 Porto Alegre, RS, Brazil

Hospital Vila Nova; 🇧🇷 Porto Alegre, RS, Brazil

Instituto Horizonti; 🇧🇷 Belo Horizonte, MG, Brazil

Hospital Universitário de Londrina; 🇧🇷 Londrina, PR, Brazil

Santa Casa de Curitiba; 🇧🇷 Curitiba, PR, Brazil

Hospital universitário de Ponta Grossa; 🇧🇷 Ponta Grossa, PR, Brazil

Hospital Nelson Cornetet; 🇧🇷 Guaíba, RS, Brazil

Hospital São Vicente de Paulo; 🇧🇷 Passo Fundo, RS, Brazil

Fundação Universitária Instituto de Cardiologia; 🇧🇷 Porto Alegre, RS, Brazil

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, RS, Brazil

Hospital Beneficência Portuguesa de Ribeirão Preto; 🇧🇷 Ribeirão Preto, SP, Brazil

Hospital Alemão Oswaldo Cruz; 🇧🇷 São Paulo, SP, Brazil

Hospital SEPACO; 🇧🇷 São Paulo, SP, Brazil

Hospital do Coração; 🇧🇷 São Paulo, SP, Brazil