Dataset Information

Functional recovery following hospitalisation of patients diagnosed with COVID-19: a protocol for a longitudinal cohort study.

ABSTRACT:

Introduction

COVID-19 is an international public health crisis with more than 132 million infections worldwide. Beyond acute infection, emerging data indicate patients diagnosed with COVID-19 may experience persistent sequelae similar to survivors of sepsis or acute respiratory syndromes, including mobility limitations and fatigue. However, there is limited evidence on the trajectory of functional recovery in those hospitalised with COVID-19. The primary aim of the Coronavirus Registry Functional Recovery (COREG-FR) study is to understand the trajectory of functional recovery among individuals hospitalised for COVID-19 over the medium (up to 6 months) and longer term (6-12 months) that will guide clinical care and optimal management of serious COVID-19 illness and recovery.

Methods and analysis

COREG-FR is a multicentre longitudinal cohort study. We will enrol a minimum of 211 adults age 18 years and older with COVID-19 from five hospitals. Participants will be followed from admission to hospital as an inpatient, to hospital discharge, and at 3-month, 6-month, 9-month and up to 12-month post-hospital discharge. We will conduct telephone interviews at ward admission and discharge, and telephone interviews plus in-person assessments of physical function and lung function at all remaining follow-ups. Our primary outcome is the Activity Measure for Post-Acute Care mobility scale measured at all time points. We will conduct linear mixed effects regression analyses to explore determinants of functional outcomes after COVID-19 illness. Subgroup analyses based on age (≤65 vs >65 years), frailty status (Clinical Frailty Scale score ≤4 vs >5) and variants of concern will be conducted.

Ethics and dissemination

COREG-FR has been approved by Research Ethics Boards at participating sites. We will disseminate this work through peer-reviewed manuscripts, presentations at national and international meetings and through the established COREG website (www.coregontario.ca). COREG-FR is designed as a data platform for future studies evaluating COVID-19 recovery.

Trial registration number

NCT04602260; Pre-results.

SUBMITTER: Reid JC

PROVIDER: S-EPMC8671848 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:AimsThe degree of cardiovascular sequelae following COVID-19 remains unknown. The aim of this study was to investigate whether cardiac function recovers following COVID-19.Methods and resultsA consecutive sample of patients hospitalized with COVID-19 was prospectively included in this longitudinal study. All patients underwent an echocardiographic examination during hospitalization and 2 months later. All participants were successfully matched 1:1 with COVID-19-free controls by age and sex. A total of 91 patients were included (mean age 63 ± 12 years, 59% male). A median of 77 days (interquartile range: 72-92) passed between the two examinations. Right ventricular (RV) function improved following resolution of COVID-19: tricuspid annular plane systolic excursion (TAPSE) (2.28 ± 0.40 cm vs. 2.11 ± 0.38 cm, P < 0.001) and RV longitudinal strain (RVLS) (25.3 ± 5.5% vs. 19.9 ± 5.8%, P < 0.001). In contrast, left ventricular (LV) systolic function assessed by global longitudinal strain (GLS) did not significantly improve (17.4 ± 2.9% vs. 17.6 ± 3.3%, P = 0.6). N-terminal pro-B-type natriuretic peptide decreased between the two examinations [177.6 (80.3-408.0) ng/L vs. 11.7 (5.7-24.0) ng/L, P < 0.001]. None of the participants had elevated troponins at follow-up compared to 18 (27.7%) during hospitalization. Recovered COVID-19 patients had significantly lower GLS (17.4 ± 2.9% vs. 18.8 ± 2.9%, P < 0.001 and adjusted P = 0.004), TAPSE (2.28 ± 0.40 cm vs. 2.67 ± 0.44 cm, P < 0.001 and adjusted P < 0.001), and RVLS (25.3 ± 5.5% vs. 26.6 ± 5.8%, P = 0.50 and adjusted P < 0.001) compared to matched controls.ConclusionAcute COVID-19 affected negatively RV function and cardiac biomarkers but recovered following resolution of COVID-19. In contrast, the observed reduced LV function during acute COVID-19 did not improve post-COVID-19. Compared to the matched controls, both LV and RV function remained impaired.

Project description:BackgroundIndividuals with schizophrenia have an increased risk of severe COVID-19 outcomes, nonetheless, no previous study has provided a year-long account of this risk, or assessed postvaccination trends in this population. This study assessed temporal trends in COVID-19 hospitalisation and mortality among people with schizophrenia during the first year of the pandemic, the predictors for COVID-19 vaccination, postvaccination infection, admission to hospital, and mortality.MethodsIn this longitudinal cohort study, people with schizophrenia (n=25 539) and controls (n=25 539) were assessed for COVID-19 outcomes before and after vaccination, up to April 30, 2021. Cox proportional hazard regression models and Kaplan-Meier analyses were done to assess longitudinal trends. The study used the databases of Clalit Health Services, the largest health-care organisation in Israel.FindingsThe sample included 51 078 participants, of which 31 141 (61·0%) male and 19 937 (39·0%) female participants, with a mean age of 51·94 years (SD 15·62). Most of the sample was from the general Jewish population (75·9%), followed by the Arab (19·1%) and Jewish Ultraorthodox population (5·1%). Overall of 51 078 individuals, 356 (0·7%) people had been hospitalised, 133 (0·3%) had died, and a total of 27 400 (53·6%) had been vaccinated. People with schizophrenia showed a higher risk for COVID-19 hospitalisation (HR 4·81, 95% CI 3·57-6·48, p<0·0001) and mortality (HR 2·52, 95% CI 1·64-3·85, p<0·0001), and showed a sharper decline in survival as time progressed. The control group showed a sharper incline in probability to vaccinate (log-rank=309·88, p<0·0001). Medical comorbidity of diabetes, hypertension, obesity, or ischaemic heart disease played a significant role in predicting vaccination rates in the schizophrenia group (all p<0·0001), but not in the control group. Hospitalisation and mortality disparities remained higher among people with schizophrenia who had not been vaccinated in comparison to controls (incidence rate difference of 6·2 and 3·2, respectively) but substantially declined in fully vaccinated groups (incidence rate difference of 1·1 and -0·9, respectively).InterpretationPeople with schizophrenia have higher hospitalisation and mortality risk, yet have lower rates of vaccination than in the general population. Disparities in COVID-19 severe outcomes can be substantially reduced by national vaccination plans aimed at actively reaching out to people with schizophrenia.FundingNo funding.

Project description:IntroductionVery little is known about possible clinical sequelae that may persist after resolution of acute COVID-19. A recent longitudinal cohort from Italy including 143 patients followed up after hospitalisation with COVID-19 reported that 87% had at least one ongoing symptom at 60-day follow-up. Early indications suggest that patients with COVID-19 may need even more psychological support than typical intensive care unit patients. The assessment of risk factors for longer term consequences requires a longitudinal study linked to data on pre-existing conditions and care received during the acute phase of illness. The primary aim of this study is to characterise physical and psychosocial sequelae in patients post-COVID-19 hospital discharge.Methods and analysisThis is an international open-access prospective, observational multisite study. This protocol is linked with the International Severe Acute Respiratory and emerging Infection Consortium (ISARIC) and the WHO's Clinical Characterisation Protocol, which includes patients with suspected or confirmed COVID-19 during hospitalisation. This protocol will follow-up a subset of patients with confirmed COVID-19 using standardised surveys to measure longer term physical and psychosocial sequelae. The data will be linked with the acute phase data. Statistical analyses will be undertaken to characterise groups most likely to be affected by sequelae of COVID-19. The open-access follow-up survey can be used as a data collection tool by other follow-up studies, to facilitate data harmonisation and to identify subsets of patients for further in-depth follow-up. The outcomes of this study will inform strategies to prevent long-term consequences; inform clinical management, interventional studies, rehabilitation and public health management to reduce overall morbidity; and improve long-term outcomes of COVID-19.Ethics and disseminationThe protocol and survey are open access to enable low-resourced sites to join the study to facilitate global standardised, longitudinal data collection. Ethical approval has been given by sites in Colombia, Ghana, Italy, Norway, Russia, the UK and South Africa. New sites are welcome to join this collaborative study at any time. Sites interested in adopting the protocol as it is or in an adapted version are responsible for ensuring that local sponsorship and ethical approvals in place as appropriate. The tools are available on the ISARIC website (www.isaric.org). PROTOCOL REGISTRATION NUMBER: osf.io/c5rw3/ PROTOCOL VERSION: 3 August 2020 EUROQOL ID: 37035.