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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04412265
Other study ID # FRA-COVID
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 16, 2020
Est. completion date December 15, 2021

Study information

Verified date April 2022
Source University of Milano Bicocca
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a multicentric retro-prospective observational study that wants to evaluate the relation between frailty and clinical outcomes in elderly patients with COVID-19.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Other:
Relation between frailty and clinical outcomes in elderly patients with COVID-19.
To evaluate whether a tool built to measure frailty in elderly patients hospitalized in COVID + hospital departments are more accurate in predicting clinical outcomes compared to a clinical evaluation based on age and comorbidity. If the assessment of fragility were actually more accurate, the tool developed could be implemented in hospitals to support the clinician 's choices regarding the "roof of care" and actions to be taken undertake to prevent deterioration.

Locations

Country Name City State
Italy Dipartimento di Geriatria, Fondazione Poliambulanza Brescia
Italy Dipartimento di Medicina e Riabilitazione, Istituto Clinico Ospedale S. Anna Brescia
Italy UO Malattie Infettive, Spedali Civili Brescia
Italy UOC Medicina I a indirizzo Geriatrico, Spedali Civili Montichiari
Italy ASST Monza-Ospedale San Gerardo Monza
Italy SCDU Geriatria, AOU Città della Salute e della Scienza - Presidio Molinette Torino

Sponsors (1)

Lead Sponsor Collaborator
University of Milano Bicocca

Country where clinical trial is conducted

Italy, 

References & Publications (4)

Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8. Review. Erratum in: Lancet. 2013 Oct 19;382(9901):1328. — View Citation

Johnstone J, Parsons R, Botelho F, Millar J, McNeil S, Fulop T, McElhaney J, Andrew MK, Walter SD, Devereaux PJ, Malekesmaeili M, Brinkman RR, Mahony J, Bramson J, Loeb M. Immune biomarkers predictive of respiratory viral infection in elderly nursing home residents. PLoS One. 2014 Oct 2;9(9):e108481. doi: 10.1371/journal.pone.0108481. eCollection 2014. — View Citation

Subbe CP, Kruger M, Rutherford P, Gemmel L. Validation of a modified Early Warning Score in medical admissions. QJM. 2001 Oct;94(10):521-6. — View Citation

Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994. Erratum in: JAMA Intern Med. 2020 Jul 1;180(7):1031. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Development of a tool to measure frailty The aim of the project is to evaluate whether a tool built to measure frailty in elderly patients admitted to the COVID + hospital wards is more accurate in predicting clinical states than a clinical evaluation developed on age and comorbidity. Until patient discharge from the hospital (approximately 1 year).
Secondary A "proxy" variable of the fragility index can be built on the basis of regional administrative databases only. Assess whether a "proxy" variable of the fragility index can be built on the basis of regional administrative databases only, which is able to predict the clinical outcomes of COVID + patients better than age and comorbidities alone. Until patient discharge from the hospital (approximately 1 year).
Secondary Give elements to focus the screening policies for COVID19. Relate different levels of chronicity with the susceptibility of the elderly subject to infection to give elements to focus the screening policies for COVID19. Until patient discharge from the hospital (approximately 1 year).
Secondary Give the prevention of contagion at the elderly population level. Relate different levels of chronicity with the susceptibility of the elderly subject to infection to prevent the contagion at the elderly population level. Until patient discharge from the hospital (approximately 1 year).
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