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

NCT05935800 | Unknown DMC

• 1 other identifier: 012.HEP.2022.D
• Study Type: observational
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty; Sarcopenia; COVID-19

Outcome Measures

Primary Outcomes (2)

• To determine the impact of the COVID-19 pandemic on the prevalence of sarcopenia

  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 years

• To determine the impact of the COVID-19 pandemic on the incidence of sarcopenia

  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

  2 years

Secondary Outcomes (3)

• Changes in number of comorbidities between pre- and during/post-pandemic periods

  1 year

• Changes in type of comorbidities between pre- and during/post-pandemic periods

  1 year

• Changes in severity of comorbidities between pre- and during/post-pandemic periods

  1 year

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Not a patient at Liver Institute at Methodist Dallas

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Frailty; Sarcopenia; COVID-19

Interventions

Desmoglein 1

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Desmogleins; Desmosomal Cadherins; Cadherins; Cell Adhesion Molecules; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Antigens, Surface; Antigens; Biological Factors; Autoantigens

Study Officials

• Parvez Mantry, MD

  Methodist Health System

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 7, 2023
• Study Start: April 19, 2022
• Primary Completion: April 19, 2024
• Study Completion: April 19, 2024
• Last Updated: November 15, 2023

Record last verified: 2023-11

Locations

US (1)