Frailty, Cognitive Function and Health-related Quality of Life in Older Adults With Advanced Chronic Kidney Disease.

Sponsor

Grigore T. Popa University of Medicine and Pharmacy (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05705011

Collaborator

(none)

240

Enrollment

Location

48.4

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This observational study explores the impact of cognitive impairment and frailty in older adults with advanced chronic kidney disease ].

The main question[s] it aims to answer are:

What determines the time to initiate dialysis? Cognitive impairment or frailty?
What does predict the time to death? Presence of frailty or cognitive impairment?
What does correlate strongly with time-low health-related quality of life? frailty or cognitive impairment?

Condition or Disease	Intervention/Treatment	Phase
CKD Stage 4 CKD Stage 5 Frailty Cognitive Impairment

Study Design

Study Type:

Observational

Actual Enrollment :

240 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Frailty, Cognitive Function and Health-related Quality of Life in Older Adults With Advanced Chronic Kidney Disease: Mortality and Dialysis Initiation, a Prospective Cohort Study.

Actual Study Start Date :

Mar 1, 2019

Anticipated Primary Completion Date :

Feb 5, 2023

Anticipated Study Completion Date :

Mar 12, 2023

Outcome Measures

Primary Outcome Measures

Time to death [36 months]
The time from the assessment moment to death of an older adult with advanced CKD ( CKD stage 4 and 5).
Time to initiate dialysis. [36 months]
The time from the assessment moment to start dialysis of an older adult with advanced CKD (

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients age 65 years or older.
CKD stage 4 and 5 who were identified by two consecutive measurements of estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 separated by more than 3 months.

Exclusion Criteria:

Patients younger than 65 years old.
Chronic kidney disease stages 1,2, and 3.
Dialysis dependence
History of kidney transplantation.
Initial visit with the health care provider.
Recent acute kidney injury.
Patients who had been hospitalized for more than 2 months before the visit (because long hospitalization might affect the degree of frailty)
Patients with myocardial infarction and cerebrovascular accident 3 months before the assessment
Patients who are blind or with limb amputation.
Patients who refuse to participate.