CompletedNot Applicable

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

Romania240 participantsStarted 2019-03-01

Plain-language 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?

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time to death

Timeframe: 36 months

Time to initiate dialysis.

Timeframe: 36 months

Trial details

NCT IDNCT05705011

SponsorGrigore T. Popa University of Medicine and Pharmacy

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-03-05

View on ClinicalTrials.gov More CKD Stage 4 trials