Cohort Study for the Assessment of Long-term Impact of COVID-19 Among Mild COVID-19 Patients in Brazil
- Conditions
- COVID-19Quality of LifeDisability PhysicalDisabilities Mental
- Interventions
- Other: Patients with symptomatic COVID-19 disease not requiring hospitalization.
- Registration Number
- NCT05197647
- 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 patients with mild COVID-19. Adult patients with symptomatic COVID-19 not requiring hospitalization will be followed through structured and centralized telephone interviews performed at 1, 3, 6, 9 and 12 months after enrollment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1085
- Age ≥18 years;
- Positive polymerase chain reaction (PCR) test for SARS-CoV-2;
- At least one of the following symptoms: fever, cough, sneezing, dyspnea, fatigue, smell alteration, rhinorrhea, sore throat, myalgia, arthralgia, diarrhea;
- Outpatient COVID-19 care at the moment of enrollment (without indication for in-hospital care).
- Severe comorbidity with life expectancy less than 3 months;
- Absence of proxy for patients with communication difficulties;
- Absence of telephone contact;
- Refusal or withdrawal of agreement to participate;
- Previous enrollment in the study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with mild COVID-19 Patients with symptomatic COVID-19 disease not requiring hospitalization. Patients with symptomatic COVID-19 disease not requiring hospitalization.
- 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. The utility score derived from the EQ5D-3L ranges from 0 (death) to 1 (perfect health).
- Secondary Outcome Measures
Name Time Method 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 all-cause mortality The outcome will be assessed at 1, 3, 6, 9, and 12 months after enrollment. Incidence of all-cause mortality
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 hospitalizations The outcome will be assessed at 1, 3, 6, 9, and 12 months after enrollment. Incidence of all-cause hospitalizations
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 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)
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.
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 COVID-19 diagnosis.
Prevalence of prolonged COVID-19 symptoms The outcome will be assessed at 1, 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 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).
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).
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).
Trial Locations
- Locations (14)
Hospital Enseada Prime
🇧🇷Vitória, ES, Brazil
Hospital Leo Orsi
🇧🇷Itapetininga, SP, Brazil
Hospital Moinhos de Vento
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Instituto Horizonti
🇧🇷Belo Horizonte, MG, Brazil
Clinica Silvestre Santé
🇧🇷Rio Branco, AC, Brazil
Hospital Metropolitano Célio de Castro
🇧🇷Belo Horizonte, MG, Brazil
Hospital do Coração do Mato Grosso do Sul
🇧🇷Campo Grande, MS, Brazil
Hospital Universitário de Ponta Grossa
🇧🇷Ponta Grossa, PR, Brazil
Instituto Procardio
🇧🇷Joinville, SC, Brazil
Hospital Vila Nova
🇧🇷Porto Alegre, RS, Brazil
Hospital do Coração
🇧🇷São Paulo, SP, Brazil
Hospital Santa Paula
🇧🇷São Paulo, SP, Brazil
Hospital de Clínicas de Ribeirão Preto
🇧🇷Ribeirão Preto, SP, Brazil
Hospital Alemão Oswaldo Cruz
🇧🇷São Paulo, SP, Brazil