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Frailty in Elderly Patients With COVID-19 (FRA-COVID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04412265
Recruitment Status : Recruiting
First Posted : June 2, 2020
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
University of Milano Bicocca

Brief Summary:
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.

Condition or disease Intervention/treatment
Covid19 Other: Relation between frailty and clinical outcomes in elderly patients with COVID-19.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Relationship Between Frailty and Clinical Outcomes in Elderly Patients With COVID-19
Actual Study Start Date : April 16, 2020
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study will be conducted on all patients hospitalized in COVID+ departments of the S.Gerardo Hospital of Monza (Geriatrics Unit, First Aid Unit and Emergency Medicine, Gastroenterology Unit, Infectious Diseases Unit).
Criteria

Inclusion criteria

  • Diagnosis of COVID related pneumonia
  • Informed consent freely granted

Exclusion criteria

- Age less than 18 years


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04412265


Contacts
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Contact: Giuseppe Bellelli +39 039 233 9638 giuseppe.bellelli@unimib.it

Locations
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Italy
ASST Monza-Ospedale San Gerardo Recruiting
Monza, Italy
Contact: Giuseppe Bellelli         
Sponsors and Collaborators
University of Milano Bicocca
Publications:
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Responsible Party: University of Milano Bicocca
ClinicalTrials.gov Identifier: NCT04412265    
Other Study ID Numbers: FRA-COVID
First Posted: June 2, 2020    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Milano Bicocca:
Coronavirus
sars-covid-2
coronavirus infection
geriatrics
Additional relevant MeSH terms:
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Frailty
Pathologic Processes