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

NCT05705011 | Completed

• 1 other identifier: Nephrogeriatrics
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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?

Conditions

CKD Stage 4; CKD Stage 5; Frailty; Cognitive Impairment

Keywords

CKD; FRAILTY; HRQOL

Outcome Measures

Primary Outcomes (2)

• 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

• Time to initiate dialysis.

  The time from the assessment moment to start dialysis of an older adult with advanced CKD (

  36 months

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Older adults are diagnosed with advanced chronic kidney disease, namely, stage 4 and stage 5.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Grigore T. Popa University of Medicine and Pharmacy: lead

Study Sites (1)

University of Medicine and Pharmacy "Grigore T. Popa"

Iași, 700115, Romania

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Frailty; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Hani Hussien, MD

  University of Medicine and Pharmacy "Grigore T. Popa" - Iași

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 21, 2023
• First Posted: January 30, 2023
• Study Start: March 1, 2019
• Primary Completion: March 5, 2023
• Study Completion: March 12, 2023
• Last Updated: February 15, 2024

Record last verified: 2024-02

Locations

RO (1)