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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

650

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Dec 2021

Typical duration for all trials

Geographic Reach

1 country

24 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.5 years study duration

First Submitted

Initial submission to the registry

December 20, 2021

Completed

1 day until next milestone

First Posted

Study publicly available on registry

December 21, 2021

Completed

Same day until next milestone

Study Start

First participant enrolled

December 21, 2021

Completed

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed

Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

2.3 years

First QC Date

December 20, 2021

Last Update Submit

November 3, 2023

Conditions

COVID-19 Quality of Life Disability Physical Disabilities Mental

Outcome Measures

Primary Outcomes (1)

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 outcome will be assessed 12 months after enrollment.

Secondary Outcomes (12)

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 all-cause mortality
The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
Incidence of major cardiovascular events
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.
+7 more secondary outcomes

Study Arms (1)

Hospitalized COVID-19 patients

Other: Hospitalization due to COVID-19

Interventions

Hospitalization due to COVID-19OTHER

Hospitalization due to COVID-19

Hospitalized COVID-19 patients

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Adult patients survivors of hospitalization due to proven COVID-19 disease.

You may qualify if:

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).

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Hospital Moinhos de Ventolead

Study Sites (24)

Hospital do Coração de Mato Grosso do Sul

Campo Grande, Mato Grosso do Sul, Brazil

Location

Hospital das clínicas da UFMG

Belo Horizonte, Minas Gerais, Brazil

Location

Hospital Emydio Germano

Belo Horizonte, Minas Gerais, Brazil

Location

Hospital Metropolitano Célio de Castro

Belo Horizonte, Minas Gerais, Brazil

Location

Instituto Horizonti

Belo Horizonte, Minas Gerais, Brazil

Location

Santa Casa de Curitiba

Curitiba, Paraná, Brazil

Location

Hospital Universitário de Londrina

Londrina, Paraná, Brazil

Location

Hospital universitário de Ponta Grossa

Ponta Grossa, Paraná, Brazil

Location

Hospital Universitário de Canoas

Canoas, Rio Grande do Sul, Brazil

Location

Hospital Nelson Cornetet

Guaíba, Rio Grande do Sul, Brazil

Location

Hospital das Clínicas de Passo Fundo

Passo Fundo, Rio Grande do Sul, Brazil

Location

Hospital São Vicente de Paulo

Passo Fundo, Rio Grande do Sul, Brazil

Location

Fundação Universitária Instituto de Cardiologia