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

February 14, 2024 updated by: Hani Hussien, Grigore T. Popa University of Medicine and Pharmacy

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.

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?

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Iasi, Romania, 700115
        • University of Medicine and Pharmacy "Grigore T. Popa"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to death
Time Frame: 36 months
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.
Time Frame: 36 months
The time from the assessment moment to start dialysis of an older adult with advanced CKD (
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grigore T. Popa University of Medicine and Pharmacy

Investigators

  • Principal Investigator: Hani Hussien, MD, University of Medicine and Pharmacy "Grigore T. Popa" - Iași

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Actual)

March 5, 2023

Study Completion (Actual)

March 12, 2023

Study Registration Dates

First Submitted

January 21, 2023

First Submitted That Met QC Criteria

January 21, 2023

First Posted (Actual)

January 30, 2023

Study Record Updates

Last Update Posted (Actual)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nephrogeriatrics

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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