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

Cognitive Impairment Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05705011
• Other study ID #: Nephrogeriatrics
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: March 12, 2023

Study information

• Verified date: February 2024
• Source: Grigore T. Popa University of Medicine and Pharmacy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: March 12, 2023
• Est. primary completion date: March 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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) <30 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.

Related Conditions & MeSH terms

• CKD Stage 4
• CKD Stage 5
• Cognitive Impairment
• Frailty
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Romania	University of Medicine and Pharmacy "Grigore T. Popa"	Iasi

Sponsors (1)

Lead Sponsor	Collaborator
Grigore T. Popa University of Medicine and Pharmacy

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to death	The time from the assessment moment to death of an older adult with advanced CKD ( CKD stage 4 and 5).	36 months
Primary	Time to initiate dialysis.	The time from the assessment moment to start dialysis of an older adult with advanced CKD (	36 months