Frailty, Cognitive Function and Health-related Quality of... | NCT05705011

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

NCT05705011

Sponsor

Grigore T. Popa University of Medicine and Pharmacy

Status

Completed

Last Update Posted

Feb 15, 2024Actual

Enrollment

240Actual

Phase

Not provided

Conditions

CKD Stage 4
CKD Stage 5
Frailty
Cognitive Impairment

Interventions

Not provided

Countries

Romania

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2019Actual

Primary Completion Date

Mar 5, 2023Actual

Completion Date

Mar 12, 2023Actual

First Submitted Date

Jan 21, 2023

First Submission Date that Met QC Criteria

Jan 21, 2023

First Posted Date

Jan 30, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2024

Last Update Posted Date

Feb 15, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hani Hussien, Doctor, Grigore T. Popa University of Medicine and PharmacyPrincipal Investigator

Lead Sponsor

Grigore T. Popa University of Medicine and PharmacyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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?

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

240Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hani Hussien, MD	University of Medicine and Pharmacy "Grigore T. Popa" - Iași	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Medicine and Pharmacy "Grigore T. Popa"		Iași		700115	Romania

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D000073496	Frailty
D060825	Cognitive Dysfunction

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided