Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06430073
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-03-26
Brief Title:
Effect of Infections and Global DNA Methylation on Frailty Trajectories in Hospitalized Older Patients INFRAGEN
Sponsor:
University Hospital of Ferrara
Organization:
University Hospital of Ferrara
Study Overview
Official Title:
Effect of Infections and Global DNA Methylation on Frailty Trajectories in Hospitalized Older Patients a Multicenter Observational Study INFRAGEN
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INFRAGEN
Brief Summary:
This prospective multicenter study aims at exploring the impact of infections on intra-hospital and 3-month changes in the frailty profile of older inpatients
To understand the complex pathways under the relationship between infections and frailty this study will evaluate infection-related clinical and biochemical markers of systemic inflammation and geneticsepigenetics markers at ward admission
The interplay between clinical functional and geneticsepigenetics factors will be evaluated in a subgroup of patients by testing whether 3-month changes in frailty concur with changes in the genomic DNA markers This study will help characterize the pathophysiological mechanisms of frailty and identify at-risk conditions that may accelerate its course
To understand the complex pathways under the relationship between infections and frailty this study will evaluate infection-related clinical and biochemical markers of systemic inflammation and geneticsepigenetics markers at ward admission
The interplay between clinical functional and geneticsepigenetics factors will be evaluated in a subgroup of patients by testing whether 3-month changes in frailty concur with changes in the genomic DNA markers This study will help characterize the pathophysiological mechanisms of frailty and identify at-risk conditions that may accelerate its course
Detailed Description:
Infectious diseases are among the most common causes of hospitalization in older adults Indeed recent data report that more than 15 of hospital admissions in adults 65 years or older are due to infections mainly in the urinary and respiratory tracts Frailty is a well-known geriatric syndrome characterized by reduced individual resilience and increased vulnerability to external stressors The prevalence of frailty ranges from around 10 in the community setting to almost 50 among institutionalized individuals
Although both infectious diseases and frailty are associated with negative outcomes for the health of older adults and the healthcare system their interplay has not been largely explored In particular it is not clear whether and to which extent acute infectious diseases might affect frailty fastening its development or hampering its reversion
The overall goal of the proposed project is to evaluate the impact of acute infections on frailty trajectories in older hospitalized patients from the pre-admission status to 3 months after hospital discharge Moreover a comprehensive set of sociodemographic clinical functional and geneticepigenetic factors will be assessed as possible effect modifiers in the association between infections and frailty trajectories
This multicenter prospective observational study includes four geriatric wards Ferrara Padova Milano and Napoli and involves individuals with no or mild-to-moderate frailty A novel and interesting aspect will be represented by the analysis of genetic and epigenetic factors ie global DNA methylation and telomere length This point will make possible exploring the complex pathophysiologic mechanisms of frailty development using a translational approach involving both basic science and clinical researchers
Overall this study will help better identify at-risk conditions that may accelerate the course of frailty Therefore the project findings may promote the importance of interventions that could counteract frailty development during the hospital stay and should be addressed primarily to the categories of patients at highest risk
Although both infectious diseases and frailty are associated with negative outcomes for the health of older adults and the healthcare system their interplay has not been largely explored In particular it is not clear whether and to which extent acute infectious diseases might affect frailty fastening its development or hampering its reversion
The overall goal of the proposed project is to evaluate the impact of acute infections on frailty trajectories in older hospitalized patients from the pre-admission status to 3 months after hospital discharge Moreover a comprehensive set of sociodemographic clinical functional and geneticepigenetic factors will be assessed as possible effect modifiers in the association between infections and frailty trajectories
This multicenter prospective observational study includes four geriatric wards Ferrara Padova Milano and Napoli and involves individuals with no or mild-to-moderate frailty A novel and interesting aspect will be represented by the analysis of genetic and epigenetic factors ie global DNA methylation and telomere length This point will make possible exploring the complex pathophysiologic mechanisms of frailty development using a translational approach involving both basic science and clinical researchers
Overall this study will help better identify at-risk conditions that may accelerate the course of frailty Therefore the project findings may promote the importance of interventions that could counteract frailty development during the hospital stay and should be addressed primarily to the categories of patients at highest risk
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None