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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04739449
Other study ID # HUM00186126
Secondary ID 3P30AG024824-16S
Status Withdrawn
Phase N/A
First received
Last updated
Start date December 4, 2021
Est. completion date March 2022

Study information

Verified date November 2021
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Nursing homes have long faced special challenges in implementing effective infection prevention programs, including limited resources and diagnostic challenges in a frail functionally disabled long-stay population. Advancing our understanding of the transmission of SARS-CoV-2 within these facilities for vulnerable populations deserves urgent and further investigation. Environmental contamination with SARS-CoV-2 that is reported in limited studies highlights the potential importance of transmission between patients, their environment, and healthcare providers via direct and indirect contact. This study seeks to characterize the epidemiology of SARS-CoV- 2 in the NH patient room environment over time and the risk of transmission to near and far environments, with the explicit intent of developing integrated, simple COVID-19 infection prevention strategies that can be reported to and implemented throughout other nursing homes and long-term care facilities.


Description:

In order to achieve these goals the study is being performed at four different nursing homes and will include patients with active or with recent COVID-19 infection, as well as nursing home staff members. The study will test a multimodal aging-friendly intervention including four components and hypothesizes that the implementation of this organizational, educational, quality improvement program will be associated with lower odds of SARS-CoV-2 transmission to the environment.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 2022
Est. primary completion date February 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria for nursing home patients: - 18 years of age or older - Residing in a participating nursing home facility - Active or recent (last 14 days) COVID-19 infection Exclusion criteria for nursing home patients: - Not located in a participating nursing home facility Inclusion criteria for healthcare workers: - Healthcare worker at a participating nursing home facility Exclusion criteria for healthcare workers: - None

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Coaching, Cleaning, Communication, Collaboration
Coaching staff Cleaning protocols, standardized Communication with staff and leadership Collaboration with local expertise

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Michigan National Institute on Aging (NIA)

Outcome

Type Measure Description Time frame Safety issue
Primary Surface contamination with SARS-CoV-2 Prevalence of SARS-CoV-2 on surfaces in COVID-19 positive patient rooms 3 months, depending on COVID-19 epidemiology
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