Skip to content

Benefit of Expanded Surveillance of Nursing Homes During the COVID-19 Pandemic

Mobile PCR-based Surveillance for SARS-CoV-2 to Reduce Visiting Restrictions in Nursing Homes During the COVID-19 Pandemic

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04933981
Enrollment
1587
Registered
2021-06-22
Start date
2020-10-15
Completion date
2021-06-30
Last updated
2024-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 Respiratory Infection, SARS-CoV-2 Infection

Keywords

Surveillance, COVID-19 pandemic, nursing homes, visiting restrictions during the COVID-19 pandemic

Brief summary

Residents in nursing homes for the senior citizens (NH) are at high risk for death from COVID-19. We investigated whether repeated non-mandatory RT-PCR SARS-CoV-2 surveillance of NH staff and visitors reduces COVID-19 incidence rates in NH residents and allows to reduce visiting restrictions.

Detailed description

Nursing homes for senior citizens are considered risk areas for the transmission of SARS-CoV-2. To protect these risk groups, different strategies have been implemented within the framework of legally applicable conditions. The aim of this study is to observe two procedural standards (e.g. visiting restrictions, hygiene measurements): * On the one hand, a standard procedure without testing of visitors and employees and * on the other hand, a standard procedure with additional surveillance by voluntary testing of visitors and staff for SARS-CoV-2 and associated relaxation of measures for contact of visitors with residents. Both standard procedures are designed to ensure adequate protection against infection. The standard procedure with the use of relaxing the measures after testing aims to make the experience of social isolation more bearable for the residents of care facilities and thus less stressful from a psychological point of view. The extent of such possible effects is not the subject of the present study. The primary aim of the study is to observe the number of SARS-CoV-2 infections among residents of nursing homes for senior citizens under different procedural standards for infection control. In this study, various measures specified by care institutions for visits to senior citizens' homes are accompanied by scientific screening. The aim of the screening and the analysis of infection protection measures is to enable this vulnerable group to regain participation in society but still slow down the spread of the virus and prevent an outbreak. The (mobile) infection control center (Coronamobil) of the University Hospital of Cologne (UKK) makes a decisive contribution to the longitudinal investigation of a risk population and to the early detection of chains of infection in addition to the surveillance carried out by the authorities. In this study, the Coronamobil and personnel are provided to avoid an additional screening burden for the homes. Surveillance of nursing homes allows protection of particularly vulnerable populations in the SARS-CoV-2 pandemic, and additional controlled contact. An evidence-based, safe and human visit concept could be transferred from Cologne to the whole of Germany. The resulting scientific knowledge would additionally provide a foundation for the control of future outbreak situations.

Interventions

DIAGNOSTIC_TESTNasopharyngeal swab for SARS-CoV-2

in the interventional group, regular, i.e. twice to three times weekly, SARS-CoV-2 testing was offered to health-care workers and visitors of nursing homes

Sponsors

City Council of Cologne, Department of Public Health, NRW, Germany
CollaboratorUNKNOWN
City Council of Cologne, Department of Social Affairs, Health and Environment, NRW, Germany
CollaboratorUNKNOWN
University of Cologne
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 99 Years
Healthy volunteers
Yes

Inclusion criteria

* One-time or frequent visitors in care facilities of the INH group who want to be tested for SARS-CoV-2 voluntarily * employees (HCW) in care facilities of the INH group who want to be tested voluntarily * Successful declaration of consent via the UKK Corona web tool

Exclusion criteria

* Visitors and employees in care facilities of the INH group with signs of SARS-CoV-2 infection * No participants in the context of the study are in principle: * one-time and frequent visitors in care facilities of the CNH group * employees in care facilities of the CNH group * Residents in care facilities of the CNH and the INH group

Design outcomes

Primary

MeasureTime frameDescription
SARS-CoV-2 infection among residentsOct 15th until Dec 18th, 2020SARS-CoV-2 infection among residents in INH and CNH (proof of SARS-CoV-2 DNA on nasopharyngeal swab with or without symptoms of SARS-CoV-2 infection)

Secondary

MeasureTime frameDescription
SARS-CoV-2 infection among visitors and health-care workers (HCW) of INHOct 15th until Dec 18th, 2020proof of SARS-CoV-2 DNA (asymptomatic and symptomatic) on nasopharyngeal swab among visitors and HCW in INH
Comparison of sensitivity of SARS-CoV-2 rtPCR and SARS-CoV-2 rapid antigen testsOct 15th until Dec 18th, 2020Ct values in RT-PCR samples of SARS-CoV-2 PCR
Overall mortality, COVID-19 related mortality, and excess mortalityup to two weeks after study completionOverall mortality, COVID-19 related mortality defined as death while infected with SARS-CoV-2, and excess mortality were assessed by comparing NH mortality data of the same period in the previous year.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026