- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05021575
Effects of COVID-19 Pandemic on a Health Care System: Case Study of the CirculatORy System in LiThuania (COVID-COR-LT)
Effects of COVID-19 Pandemic on Personal and Public Health and Functioning of Health Care System: Case Study of the CirculatORy System in LiThuania
Study Overview
Status
Conditions
Detailed Description
COVID-19 pandemic has greatly affected the world and changed health care in almost every country. During the spring of 2020, first pandemic wave was of different scale in different countries. In countries affected by the virus the most, a majority of the studies focused on the direct impact of COVID-19 on community health. It was noticed promptly that the novel virus is especially high-risk for patients with cardiovascular comorbidities. Furthermore, the collateral damage of COVID-19 pandemic on the provision of cardiovascular (CV) care and cardiovascular mortality was also reported early in several nationwide and selected cohort studies. The research was mostly focused on acute cardiovascular conditions; changes in hospital admissions and early mortality after myocardial infarction were also often analysed. Meanwhile, a substantial proportion of routine appointments, diagnostic and therapeutic procedures was cancelled. Data on the changes in total national CV services, including out- and in-patient health care facilities, acute and chronic conditions, during the outbreak, between the two pandemic waves and onwards are scarce. First case of COVID-19 in Lithuania was confirmed on 28th February 2020. First nationwide quarantine was introduced by Lithuanian government on 16th March and ended on 16th June. In that period, although Lithuania was reported among the least affected countries according to World Health Organization - 1 773 COVID-19 cases were recorded and 86 patients (of whom 10 patients died from other causes after testing positive for SARS-CoV-2) had died before the end of quarantine, Lithuanian government limited contact appointments to urgent conditions only. The utmost efforts to provide triage, follow-up care by telephone call and e-prescriptions were recommended. This greatly affected availability of cardiovascular care. The second pandemic wave in Lithuania was substantially more severe. Consequently, the second nationwide quarantine was implemented on 7th November, 2020. Contact appointments were not limited by the government; however, the scope of CV care was again negatively affected, mostly by the strained health care system.
We analysed the indirect impact of the COVID-19 pandemic in a country, which was hit by two very different pandemic waves. The objectives of this population-based study were: (1) to assess the impact of the COVID-19 pandemic on CV care (2) to compare rates of outpatient care visits and hospitalisations of cardiovascular patients in different periods of 2019 and 2020 (3) to compare the rates of CV mortality in Lithuania in different periods of 2019 and 2020 (4) to investigate sex and age differences in CV care and CV mortality
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Vilnius, Lithuania
- Vilnius University
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Vilnius, Lithuania
- Institute of Hygiene
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Vilnius, Lithuania
- National Health Insurance Fund under the Ministry of Health, Lithuania
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- ≥18 years old adult patients
- Included in either National Health Insurance Fund outpatient and hospitalisation registries related to cardiovascular diseases from 1st January 2019 to 30th November 2020
- Included in Causes of Death Registry from Institute of Hygiene with cardiovascular diagnoses from 1st January 2019 to 31st December 2020.
Exclusion Criteria:
- Cases, when sex was not available were excluded from sex differences analysis.
- Death certificates where place of death was unspecified were excluded from death place analysis
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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2020
Data on outpatient care, hospitalisation and cardiovascular mortality were collected for the year 2020.
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Outpatient data from 1 January to 30 November of the analysed year were obtained from National Health Insurance Fund under the Ministry of Health. Outpatient data related to cardiovascular diseases (CVD) were collected as described:
Date of the visit, patient age, sex and municipality, service level (primary, secondary or tertiary), type of service and main diagnosis were recorded. Hospitalisation data from 1 January to 30 November of the analysed year were obtained from National Health Insurance Fund under the Ministry of Health. Data on hospitalisation were collected if any of the diagnoses (principal or secondary) were in I00-I99 range. Hospitalisation data covered hospitalisation date, patient age, sex, municipality and outcome. Data on cardiovascular procedures performed during hospitalisations included date of the procedure and ACHI (Australian Classification of Health Interventions) code.
Data on cardiovascular mortality were obtained from death certificates provided by Causes of Death Registry from Institute of Hygiene and covered the period from 1 January to 31 December of the analysed year.
Death certificates were included in the study when cause of death was adjudicated to be in I00-I99 range.
Date and place of death (hospital, home, other or unspecified), patient age and sex were recorded.
Demographic, clinical and percutaneous coronary intervention (PCI) related data were collected from 1st March to 30th June of the analysed year.
The timing of the chest pain onset, call for medical help, first medical contact (FMC), arrival to PCI centre, and PCI procedure were analysed.
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2019
Data on outpatient care, hospitalisation and cardiovascular mortality were collected for the year 2019.
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Outpatient data from 1 January to 30 November of the analysed year were obtained from National Health Insurance Fund under the Ministry of Health. Outpatient data related to cardiovascular diseases (CVD) were collected as described:
Date of the visit, patient age, sex and municipality, service level (primary, secondary or tertiary), type of service and main diagnosis were recorded. Hospitalisation data from 1 January to 30 November of the analysed year were obtained from National Health Insurance Fund under the Ministry of Health. Data on hospitalisation were collected if any of the diagnoses (principal or secondary) were in I00-I99 range. Hospitalisation data covered hospitalisation date, patient age, sex, municipality and outcome. Data on cardiovascular procedures performed during hospitalisations included date of the procedure and ACHI (Australian Classification of Health Interventions) code.
Data on cardiovascular mortality were obtained from death certificates provided by Causes of Death Registry from Institute of Hygiene and covered the period from 1 January to 31 December of the analysed year.
Death certificates were included in the study when cause of death was adjudicated to be in I00-I99 range.
Date and place of death (hospital, home, other or unspecified), patient age and sex were recorded.
Demographic, clinical and percutaneous coronary intervention (PCI) related data were collected from 1st March to 30th June of the analysed year.
The timing of the chest pain onset, call for medical help, first medical contact (FMC), arrival to PCI centre, and PCI procedure were analysed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of outpatient care visits for cardiovascular reasons in Lithuania in 2019 and 2020
Time Frame: 2 years
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Assessing the impact of the COVID-19 pandemic on provision of CV care at the national and regional level in Lithuania
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2 years
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Number of cardiovascular hospitalisations in Lithuania in 2019 and 2020
Time Frame: 2 years
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Assessing the impact of the COVID-19 pandemic on provision of CV care at the national and regional level in Lithuania
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2 years
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Cardiovascular mortality rates in Lithuania in 2019 and 2020
Time Frame: 2 years
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Assessing the impact of the COVID-19 pandemic on provision of CV care at the national and regional level in Lithuania
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2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Evaluation of sex and age differences in changes of CV care provision and CV deaths during the pandemic and comparison between 2019 and 2020
Time Frame: 2 years
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Comparison of cardiovascular outpatient care visits, hospitalisation numbers and cardiovascular mortality rates between men and women and between different age groups.
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2 years
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In-hospital mortality rates in Lithuania in 2019 and 2020
Time Frame: 2 years
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Comparison of mortality rate in hospitalised patients in Lithuania between 2019 and 2020
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2 years
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Comparison of distribution of death places in Lithuania in 2019 and 2020
Time Frame: 2 years
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Assessing the differences in the death places written in the death certificates of the people deceased from cardiovascular causes between 2019 and 2020
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2 years
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Comparison of all-cause mortality during the hospital stay and at 3 months of follow-up in patients presenting to a tertiary care centre with acute coronary syndrome during the first quarantine in 2020 and in a corresponding period of 2019
Time Frame: 3 months
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3 months
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- S-COV-20-27 (Other Grant/Funding Number: Research Council of Lithuania)
- 2020/8-1247-730 (Other Identifier: Lithuanian Bioethics Commitee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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