Cohort Study for the Assessment of Long-term Impact of COVID-19 Among Mild COVID-19 Patients in Brazil
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with mild COVID-19 Patients with symptomatic COVID-19 disease not requiring hospitalization. |
Other: Patients with symptomatic COVID-19 disease not requiring hospitalization.
Patients with symptomatic COVID-19 disease not requiring hospitalization.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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 hospitalizations [The outcome will be assessed at 1, 3, 6, 9, and 12 months after enrollment.]
Incidence of all-cause hospitalizations
- 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).
- 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).
- 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).
- 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).
- 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.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥18 years;
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Positive polymerase chain reaction (PCR) test for SARS-CoV-2;
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At least one of the following symptoms: fever, cough, sneezing, dyspnea, fatigue, smell alteration, rhinorrhea, sore throat, myalgia, arthralgia, diarrhea;
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Outpatient COVID-19 care at the moment of enrollment (without indication for in-hospital care).
Exclusion Criteria:
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Severe comorbidity with life expectancy less than 3 months;
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Absence of proxy for patients with communication difficulties;
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Absence of telephone contact;
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Refusal or withdrawal of agreement to participate;
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Previous enrollment in the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Moinhos de Vento | Porto Alegre | Rio Grande Do Sul | Brazil |
Sponsors and Collaborators
- Hospital Moinhos de Vento
Investigators
- Principal Investigator: Regis Rosa, MD, PhD, Hospital Moinhos de Vento
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pos-COVID Brasil 2