Frailty in Elderly Patients With COVID-19

NCT04412265 | Completed DMC

• 1 other identifier: FRA-COVID
• Study Type: observational
• Target: 1,344
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Covid19

Keywords

Coronavirus; sars-covid-2; coronavirus infection; geriatrics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• A "proxy" variable of the fragility index can be built on the basis of regional administrative databases only.

  Until patient discharge from the hospital (approximately 1 year).

• Give elements to focus the screening policies for COVID19.

  Until patient discharge from the hospital (approximately 1 year).

• Give the prevention of contagion at the elderly population level.

  Until patient discharge from the hospital (approximately 1 year).

Study Arms (1)

Covid 19 patients

The study will be conducted on all patients hospitalized affected by pneumonia COVID related.

Other: Relation between frailty and clinical outcomes in elderly patients with COVID-19.

Interventions

Relation between frailty and clinical outcomes in elderly patients with COVID-19. OTHER

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.

Covid 19 patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will be conducted on all patients hospitalized in COVID+ departments of the participating sites.

You may qualify if:

• Diagnosis of COVID related pneumonia
• Informed consent freely granted

You may not qualify if:

• \- Age less than 18 years

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (6)

Dipartimento di Geriatria, Fondazione Poliambulanza

Brescia, Italy

Location

Dipartimento di Medicina e Riabilitazione, Istituto Clinico Ospedale S. Anna

Brescia, Italy

Location

UO Malattie Infettive, Spedali Civili

Brescia, Italy

Location

UOC Medicina I a indirizzo Geriatrico, Spedali Civili

Montichiari, Italy

Location

ASST Monza-Ospedale San Gerardo

Monza, Italy

Location

SCDU Geriatria, AOU Città della Salute e della Scienza - Presidio Molinette

Torino, Italy

Location

Related Publications (5)

• 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.

  PMID: 23395245 BACKGROUND

• 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.

  PMID: 25275464 BACKGROUND

• 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. doi: 10.1093/qjmed/94.10.521.

  PMID: 11588210 BACKGROUND

• 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.

  PMID: 32167524 BACKGROUND

• Trevisan C, Grande G, Rebora P, Zucchelli A, Valsecchi MG, Foca E, Ecarnot F, Marengoni A, Bellelli G. Early Onset Delirium During Hospitalization Increases In-Hospital and Postdischarge Mortality in COVID-19 Patients: A Multicenter Prospective Study. J Clin Psychiatry. 2023 Aug 21;84(5):22m14565. doi: 10.4088/JCP.22m14565.

  PMID: 37616485 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2020
• First Posted: June 2, 2020
• Study Start: April 16, 2020
• Primary Completion: June 30, 2021
• Study Completion: December 15, 2021
• Last Updated: April 28, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (6)