NCT06458322 Quality of Life in Patients Transitioning to Home or In-Center Dialysis (QUALIFY CKD-to-HOME)
| NCT ID | NCT06458322 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ciusss de L'Est de l'Île de Montréal |
| Condition | Chronic Kidney Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2022-07-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2022-07-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this study is to evaluate quality of life (QoL) and frailty trajectories from advanced chronic kidney disease (CKD) to after dialysis initiation, specifically comparing patients choosing home dialysis and in-center hemodialysis. The main questions it aims to answer are: 1. What is the trajectory of QoL in patients transitioning from advanced CKD to dialysis (up to 12 months after initiation) and how does these changes differ for patients oriented towards home dialysis and in-center hemodialysis? 2. Is the development of frailty after dialysis initiation less likely in patient pursuing home dialysis? 3. What is the variation in other PROMs and health outcomes (fatigue, anxiety \& depression, general assessment, cognitive function) form advanced CKD to the first 12 months after dialysis initiation? 4. What are the predictors of severe decline in QoL, frailty and other important health outcomes (fatigue, cognition, anxiety \& depression) during CKD G5 follow-up and after 12 months post dialysis initiation? Participants will be ask to: * Answer some questions and complete questionnaires each 3 months; * Do a a grip test and a walking test each 6 months to evaluate their frailty;
Eligibility Criteria
Inclusion Criteria: * Adult patients followed in advanced CKD clinic; * eGFR ≤12 mL/min/1.73m2 96; * Understand English or French. Exclusion Criteria: * Orientation toward conservative treatment; * Planned kidney transplantation \< 6 months; * Unable to provide consent due to severe cognitive or psychiatric disease; * Previous treatment with dialysis \> 3 month; * Life expectancy \< 6 months.
Contact & Investigator
Annie-Claire Nadeau-Fredette, MD
PRINCIPAL INVESTIGATOR
Ciusss de L'Est de l'Île de Montréal
Frequently Asked Questions
Who can join the NCT06458322 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Kidney Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06458322 currently recruiting?
Yes, NCT06458322 is actively recruiting participants. Contact the research team at emilie.robitaille.cemtl@ssss.gouv.qc.ca for enrollment information.
Where is the NCT06458322 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT06458322 clinical trial?
NCT06458322 is sponsored by Ciusss de L'Est de l'Île de Montréal. The principal investigator is Annie-Claire Nadeau-Fredette, MD at Ciusss de L'Est de l'Île de Montréal. The trial plans to enroll 200 participants.
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