COVID-19, Disabilities Mental, Disability Physical, Quality of Life
Conditions
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.
Interventions
OTHERPatients with symptomatic COVID-19 disease not requiring hospitalization.
Patients with symptomatic COVID-19 disease not requiring hospitalization.
Sponsors
Hospital Moinhos de Vento
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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). |
| 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). |
| 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. |
| 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). |
Countries
Brazil
Outcome results
None listed