An observational study in COVID-19, Quality of Life and Disability Physical, sponsored by Hospital Moinhos de Vento. Status unknown at 14 sites in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-07.
Sponsored by Hospital Moinhos de Vento · Observational
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 1,085 is above the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →Hospital Moinhos de Vento is the lead sponsor of 34 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients survivors with proven mild symptomatic COVID-19 disease not requiring hospitalization.
Exclusion Criteria:
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.
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).
Time frame: The outcome will be assessed 12 months after enrollment.
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).
Time frame: The outcome will be assessed at 3, 6, and 9 months after enrollment.
Incidence of all-cause mortality
Incidence of all-cause mortality
Time frame: 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)
Time frame: The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
Incidence of hospitalizations
Incidence of all-cause hospitalizations
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
Plan to share: Undecided — The authors encourage interested parties to contact the corresponding author with data sharing requests, including for access to additional unpublished data.
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Hospital Moinhos de Vento