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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05935800
Recruitment Status : Active, not recruiting
First Posted : July 7, 2023
Last Update Posted : November 15, 2023
Sponsor:
Information provided by (Responsible Party):
Methodist Health System

Study Description
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Brief Summary:
Frailty is associated with higher rates of morbidity, mortality, and failure to rescue after major surgical procedures [1]. 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.

Condition or disease Intervention/treatment
Frailty Sarcopenia COVID-19 Behavioral: COVID Patients who Underwent pre-transplant frailty assessment (PFA) at MDMC

Detailed Description:
This study seeks to examine whether the SARS-CoV-2 (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.
Study Design
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Study Type : Observational
Estimated Enrollment : 208 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Effect of the COVID-19 Pandemic on Frailty in Liver Transplant Candidates
Actual Study Start Date : April 19, 2022
Estimated Primary Completion Date : April 19, 2024
Estimated Study Completion Date : April 19, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Behavioral: COVID Patients who Underwent pre-transplant frailty assessment (PFA) at MDMC
    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
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Primary Outcome Measures :
  1. To determine the impact of the COVID-19 pandemic on the prevalence of sarcopenia [ Time Frame: 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

  2. To determine the impact of the COVID-19 pandemic on the incidence of sarcopenia [ Time Frame: 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 Outcome Measures :
  1. Changes in number of comorbidities between pre- and during/post-pandemic periods [ Time Frame: 1 year ]
    Changes in number of comorbidities between pre- and during/post-pandemic periods

  2. Changes in type of comorbidities between pre- and during/post-pandemic periods [ Time Frame: 1 year ]
    Changes in type of comorbidities between pre- and during/post-pandemic periods

  3. Changes in severity of comorbidities between pre- and during/post-pandemic periods [ Time Frame: 1 year ]
    Changes in severity of comorbidities between pre- and during/post-pandemic periods


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Age 18 years and older Underwent pre-transplant frailty assessment (PFA) at MDMC 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.
Criteria

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
Contacts and Locations
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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): NCT05935800


Locations
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United States, Texas
Methodist Dallas Medical Center
Dallas, Texas, United States, 75203
Sponsors and Collaborators
Methodist Health System
Investigators
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Principal Investigator: Parvez Mantry, MD Methodist Health System
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Methodist Health System
ClinicalTrials.gov Identifier: NCT05935800    
Other Study ID Numbers: 012.HEP.2022.D
First Posted: July 7, 2023    Key Record Dates
Last Update Posted: November 15, 2023
Last Verified: November 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Sarcopenia
Frailty
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
 RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Pathologic Processes
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical