Frailty in Elderly Patients With COVID-19

Overview

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

Full Title of Study: “Relationship Between Frailty and Clinical Outcomes in Elderly Patients With COVID-19″

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: June 2020

Detailed Description

BACKGROUND:

Assessment of frailty is today the best way to evaluate the biological age of the elderly person. Fragility can be defined as a syndrome selected by the reduction of organized reserves and by the decreased resistance to "stressors", resulting from the cumulative decline of multiple physiological systems that cause vulnerabilities and adverse consequences.

The impact of fragility on clinical outcomes has been investigated in numerous studies conducted on elderly patients in various care setting, proving in all of them a significant and more reliable predictor of variables such as age, comorbidity and individual pathologies, short and long-term mortality, length of stay and the onset of complications.

Previous studies have already shown that frail older adults have a greater susceptibility to viral infections (including non-COVID-19 coronavirus) due to a malfunction of their immune system.

The identification of fragility could therefore be particularly useful for identifying subjects at risk of negative outcomes (worsening of respiratory parameters, need for intubation, mortality) even in a ward with COVID + patients. In other words, the imperceptible clinical heterogeneity behind the age parameter could be better represented by a multidimensional parameter capable of measuring the accumulation of age-related deficits.

SAMPLE SIZE (n. patients):

The study plans to recruit 30 subjects per week on average; for an expected total of about 300 subjects.

STUDY DESIGN:

The patient will be enrolled in the study when obtaining consent. In this phase the following data will be collected:

- date of birth

- gender

- demographic data

- comorbidity

- Brescia_COVID respiratory scale

- modified Early Warning Score

- delirium

- data relating to functional autonomy

- blood chemistry data at the entrance.

Using the variables that are part of the Comprehensive Geriatric Assessment, it will be possible to calculate the Frailty Index (FI), according to the Rockwood deficit accumulation model. A series of variables will then be collected relating to treatment procedures, therapies, the team's choice to maximize the care ceiling for the individual patient and the patient's clinical outcome.

Patients will be treated as per Normal Clinical Practice; no blood chemistry tests will be required in addition to the panel of tests provided by the hospital's health management for all patients with COVID-19.

Given the difficulty in systematically obtaining written informed consent and given the great public interest of the project, the research will be conducted in the context of the authorizations guaranteed by Article 89 of the GDPR EU Regulation 2016/679, which guarantees the treatment for purposes of public interest, scientific or historical research or statistical purposes of health data.

STATISTICAL ANALYSIS:

The FI will be built according to the Rockwood deficit accumulation model, taking into account a minimum number of variables that are part of the Comprehensive Geriatric Assessment. The FI will be obtained from the ratio between the number of pathological conditions present and the total number of indicators evaluated. Data from patients older than 60 years of age will be compared.

Interventions

  • 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 of the San Gerardo hospital 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.

Arms, Groups and Cohorts

  • Covid 19 patients
    • The study will be conducted on all patients hospitalized in COVID+ departments of the S.Gerardo Hospital in Monza (Geriatrics Unit, First Aid Unit and Emergency Medicine, Gastroenterology Unit, Infectious Disease Unit) affected by pneumonia COVID related.

Clinical Trial Outcome Measures

Primary Measures

  • Development of a tool to measure frailty
    • Time Frame: Until patient discharge from the hospital (approximately 1 year).
    • The aim of the project is to evaluate whether a tool built to measure frailty in elderly patients admitted to the COVID + hospital wards of San Gerardo hospital is more accurate in predicting clinical states than a clinical evaluation developed on age and comorbidity.

Secondary Measures

  • A “proxy” variable of the fragility index can be built on the basis of regional administrative databases only.
    • Time Frame: Until patient discharge from the hospital (approximately 1 year).
    • 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.
  • Give elements to focus the screening policies for COVID19.
    • Time Frame: Until patient discharge from the hospital (approximately 1 year).
    • Relate different levels of chronicity with the susceptibility of the elderly subject to infection to give elements to focus the screening policies for COVID19.
  • Give the prevention of contagion at the elderly population level.
    • Time Frame: Until patient discharge from the hospital (approximately 1 year).
    • Relate different levels of chronicity with the susceptibility of the elderly subject to infection to prevent the contagion at the elderly population level.

Participating in This Clinical Trial

Inclusion Criteria

  • Diagnosis of COVID related pneumonia
  • Informed consent freely granted

Exclusion Criteria

  • Age less than 18 years

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Milano Bicocca
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Giuseppe Bellelli, +39 039 233 9638, giuseppe.bellelli@unimib.it

References

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.

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.

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.

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.

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