The Effect of the COVID-19 Pandemic on Frailty in Liver Transplant Candidates

NCT05935800 — Active not recruiting, 208 participants, Methodist Health System

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Registry	NCT05935800
Status	Active not recruiting
Study type	Observational
Enrollment	208 (Estimated)
Sponsor	Methodist Health System (Other)
Conditions	Frailty, Sarcopenia, COVID-19
Interventions	COVID Patients who Underwent pre-transplant frailty assessment (PFA) at MDMC (Behavioral)
Dates	start 2022-04-19, primary completion 2027-04-19 (estimated), completion 2028-04-19 (estimated), first posted 2023-07-07, last updated 2026-06-10
Locations	1 site in United States

-Summary

Frailty is associated with higher rates of morbidity, mortality, and failure to rescue after major surgical procedures. Sarcopenia is degenerative loss of skeletal muscle mass and strength. It is a key component of physical frailty and is associated with poorer post-surgical outcomes due to decreased patient strength and vitality.

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+Detailed description

This study seeks to examine whether the (COVID-19) pandemic, an ongoing global health crisis that was declared a national emergency by the US Federal Government on March 13, 2020, has exacerbated both frailty and sarcopenia in a population of liver transplant candidates.

+Arms and interventions

COVID Patients who Underwent pre-transplant frailty assessment (PFA) at MDMC (Behavioral): This is a single-center, retrospective study that uses de-identified, anonymized patient data. Data from 369 liver transplant candidates who underwent pre-transplant frailty assessments at the Liver Institute at Methodist Dallas from April 1, 2018 to February 28, 2022. The study data will be divided into cohorts: pre-COVID and COVID. Specifically, the pre-COVID period will consist of the dates between April 1st, 2018 and March 12, 2020, while the COVID period will consist of the dates between March 13, 2020 and February 28th, 2022.

+Outcome measures

Primary outcomes

To determine the impact of the COVID-19 pandemic on the prevalence of sarcopenia [2 years]: To determine the impact of the COVID-19 pandemic on the prevalence of sarcopenia and frailty in patients undergoing liver transplant evaluation at Methodist Dallas Medical Center
To determine the impact of the COVID-19 pandemic on the incidence of sarcopenia [2 years]: To determine the impact of the COVID-19 pandemic on the incidence of sarcopenia and frailty in patients undergoing liver transplant evaluation at Methodist Dallas Medical Center

Secondary outcomes

Changes in number of comorbidities between pre- and during/post-pandemic periods [1 year]: Changes in number of comorbidities between pre- and during/post-pandemic periods
Changes in type of comorbidities between pre- and during/post-pandemic periods [1 year]: Changes in type of comorbidities between pre- and during/post-pandemic periods
Changes in severity of comorbidities between pre- and during/post-pandemic periods [1 year]: Changes in severity of comorbidities between pre- and during/post-pandemic periods

+Eligibility

Sex: All, ages: 18 Years to 75 Years

Inclusion Criteria:

* Age 18 years and older Underwent pre-transplant frailty assessment (PFA) at MDMC

Exclusion Criteria:

* Not a patient at Liver Institute at Methodist Dallas

+Locations (1)

Facility	City	Country	Status
Methodist Dallas Medical Center	Dallas, Texas	United States

+Investigators

Parvez Mantry, MD, Principal investigator, Methodist Health System

My Notes

Public

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