NCT05165979Active, not recruitingNot Applicable
Cohort Study for the Assessment of Long-term Impact of COVID-19 Among Moderate and Severe COVID-19 Patients in Brazil
Hospital Moinhos de Vento24 sites in 1 country650 target enrollmentStarted: December 21, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Hospital Moinhos de Vento
- Enrollment
- 650
- Locations
- 24
- Primary Endpoint
- One-year utility score of health related quality of life
Study Overview
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 survivors of hospitalization for COVID-19. Adult patients requiring hospitalization due to COVID-19 disease will be followed through structured and centralized telephone interviews performed at 3, 6, 9 and 12 months after enrollment.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥18 years;
- •Symptomatic COVID-19 disease within the last 14 days;
- •Positive polymerase chain reaction (PCR) test for SARS-CoV-2 within the last 14 days;
- •Need of hospitalization (duration ≥ 48 hours).
Exclusion Criteria
- •Severe comorbidity with life expectancy less than 3 months;
- •Death during hospitalization;
- •Absence of telephone contact;
- •Absence of proxy for patients with communication difficulties;
- •Refusal or withdrawal of agreement to participate;
- •Previous enrollment in the study.
Outcomes
Primary Outcomes
One-year utility score of health related quality of life
Time Frame: 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.
Secondary Outcomes
- Instrumental Activities of Daily Living(The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.)
- 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.)
- Incidence of major cardiovascular events(The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.)
- Prevalence of anxiety and depression symptoms(The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.)
- Incidence of rehospitalizations(The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.)
- Prevalence of prolonged COVID-19 symptoms(The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.)
- Prevalence of posttraumatic stress disorder symptoms(The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.)
- Incidence of return to work or study(The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.)
- Incidence of all-cause mortality(The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.)
- Prevalence of cognitive dysfunction(The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.)
- Incidence of new symptomatic COVID-19 infection(The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.)
- Physical functional status(The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.)
Investigators
Study Sites (24)
Loading locations...
Similar Trials
Active, not recruiting
Not Applicable
Cohort Study for the Assessment of Long-term Impact of COVID-19 Among Mild COVID-19 Patients in BrazilCOVID-19Quality of LifeDisability PhysicalDisabilities MentalNCT05197647Hospital Moinhos de Vento1,085
Not yet recruiting
Not Applicable
Long-Term Outcomes of Different Surgical Techniques for Sacral Tarlov Cysts: A Prospective Cohort StudyNCT06756984Beijing Jishuitan Hospital150
Completed
Not Applicable
A Cohort Study on the Risk Factors and the Long-term Outcomes of Post-Intensive Care Syndrome among Critical Care SurvivorsKCT0004045Dong-A University1,000
Terminated
Not Applicable
Shifts in the Respiratory Microbiome and Clinical Outcomes of SARS-CoV-2SARS-CoV-2 InfectionBacterial Respiratory Tract InfectionViral Respiratory Tract InfectionNCT04815018Pathnostics185
Active, not recruiting
Not Applicable
Burden of Disease and Functional Impairment in XLHX Linked HypophosphatemiaNCT04946409Wuerzburg University Hospital60