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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with mild COVID-19 | Patients with symptomatic COVID-19 disease not requiring hospitalization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients with symptomatic COVID-19 disease not requiring hospitalization. | Other | Patients with symptomatic COVID-19 disease not requiring hospitalization. |
|
| Measure | Description | Time Frame |
|---|---|---|
| One-year utility score of health related quality of life | 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). | The outcome will be assessed 12 months after enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| Utility score of health related quality of life at 3, 6, and 9 months | 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). | The outcome will be assessed at 3, 6, and 9 months after enrollment. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients survivors with proven mild symptomatic COVID-19 disease not requiring hospitalization.
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| Name | Affiliation | Role |
|---|---|---|
| Regis Rosa, MD, PhD | Hospital Moinhos de Vento | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Silvestre Santé | Rio Branco | Acre | Brazil | |||
| Hospital Enseada Prime |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37851732 | Background | Rover MM, Trott G, Scolari FL, Silva MMDD, Souza D, Santos RDRMD, Dagnino APA, Mesquita Neto J, Estivalete GP, Kozesinski-Nakatani AC, Marcolino MS, Barreto BB, Schvartzman PR, Antonio ACP, Robinson CC, Falavigna M, Biolo A, Polanczyk CA, Rosa RG. Health-Related Quality of Life and Long-Term Outcomes after Mildly Symptomatic COVID-19: The Post-COVID Brazil Study 2 Protocol. Arq Bras Cardiol. 2023 Sep;120(9):e20220835. doi: 10.36660/abc.20220835. English, Portuguese. |
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The authors encourage interested parties to contact the corresponding author with data sharing requests, including for access to additional unpublished data.
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| Incidence of all-cause mortality |
Incidence of all-cause mortality |
| The outcome will be assessed at 1, 3, 6, 9, and 12 months after enrollment. |
| Incidence of major cardiovascular events | Incidence of major cardiovascular events (composite endpoint of non-fatal stroke, non-fatal acute myocardial infarction, or cardiovascular death) | The outcome will be assessed at 3, 6, 9, and 12 months after enrollment. |
| Incidence of hospitalizations | Incidence of all-cause hospitalizations | The outcome will be assessed at 1, 3, 6, 9, and 12 months after enrollment. |
| Prevalence of prolonged COVID-19 symptoms | 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) | The outcome will be assessed at 1, 3, 6, 9, and 12 months after enrollment. |
| Prevalence of cognitive dysfunction | 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). | The outcome will be assessed at 3, 6, 9, and 12 months after enrollment. |
| Prevalence of anxiety and depression symptoms | 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). | The outcome will be assessed at 3, 6, 9, and 12 months after enrollment. |
| Prevalence of posttraumatic stress disorder symptoms | 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). | The outcome will be assessed at 3, 6, 9, and 12 months after enrollment. |
| Physical functional status | Physical functional status as assessed by the modified Barthel index (score ranges from 0 to 100; higher scores indicate less functional dependence). | The outcome will be assessed at 3, 6, 9, and 12 months after enrollment. |
| Instrumental Activities of Daily Living | 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). | The outcome will be assessed at 3, 6, 9, and 12 months after enrollment. |
| Incidence of return to work or study | Incidence of return to work or study among patients that were working or studying at the moment of COVID-19 diagnosis. | The outcome will be assessed at 3, 6, 9, and 12 months after enrollment. |
| Incidence of new symptomatic COVID-19 infection | 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. | The outcome will be assessed at 3, 6, 9, and 12 months after enrollment. |
| Vitória |
| Espírito Santo |
| Brazil |
| Hospital do Coração do Mato Grosso do Sul | Campo Grande | Mato Grosso do Sul | Brazil |
| Hospital Metropolitano Célio de Castro | Belo Horizonte | Minas Gerais | Brazil |
| Instituto Horizonti | Belo Horizonte | Minas Gerais | Brazil |
| Hospital Universitário de Ponta Grossa | Ponta Grossa | Paraná | Brazil |
| Hospital Moinhos de Vento | Porto Alegre | Rio Grande do Sul | Brazil |
| Hospital Vila Nova | Porto Alegre | Rio Grande do Sul | Brazil |
| Instituto Procardio | Joinville | Santa Catarina | Brazil |
| Hospital Leo Orsi | Itapetininga | São Paulo | Brazil |
| Hospital de Clínicas de Ribeirão Preto | Ribeirão Preto | São Paulo | Brazil |
| Hospital Alemão Oswaldo Cruz | São Paulo | São Paulo | Brazil |
| Hospital do Coração | São Paulo | São Paulo | Brazil |
| Hospital Santa Paula | São Paulo | São Paulo | Brazil |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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