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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

Tracking Information
First Submitted Date July 6, 2023
First Posted Date July 7, 2023
Last Update Posted Date November 15, 2023
Actual Study Start Date April 19, 2022
Estimated Primary Completion Date April 19, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 13, 2023)
  • 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
  • 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
Original Primary Outcome Measures
 (submitted: July 6, 2023)		 To determine the impact of the COVID-19 pandemic on the prevalence and incidence of sarcopenia [ Time Frame: 2 years ]
To determine the impact of the COVID-19 pandemic on the prevalence and incidence of sarcopenia and frailty in patients undergoing liver transplant evaluation at Methodist Dallas Medical Center (MDMC).
Change History
Current Secondary Outcome Measures
 (submitted: November 13, 2023)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures
 (submitted: July 6, 2023)		 Changes in sarcopenia [ Time Frame: 1 yr ]
Changes in number, type, and severity of comorbidities between pre- and during/post-pandemic
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Effect of the COVID-19 Pandemic on Frailty in Liver Transplant Candidates
Official Title The Effect of the COVID-19 Pandemic on Frailty in Liver Transplant Candidates
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Frailty
  • Sarcopenia
  • COVID-19
Intervention 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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: July 6, 2023)		 208
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 19, 2024
Estimated Primary Completion Date April 19, 2024   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05935800
Other Study ID Numbers 012.HEP.2022.D
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Methodist Health System
Original Responsible Party Same as current
Current Study Sponsor Methodist Health System
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Parvez Mantry, MD Methodist Health System
PRS Account Methodist Health System
Verification Date November 2023