Quality of life during the transition to home versus in-center dialysis
Prospective Changes in Quality of Life and Frailty in Chronic Kidney Disease Patients Transitioning to Home Versus In-Center Dialysis (QUALIFY CKD-to-HOME Study)
This project will see if people with advanced CKD who start home dialysis have better quality of life and less frailty over the first year than those who start in-center hemodialysis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ciusss de L'Est de l'Île de Montréal Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT06458322 on ClinicalTrials.gov |
What this trial studies
QUALIFY CKD-to-HOME is a prospective cohort of about 200 adults followed at seven Canadian centers with active patient-partner engagement. Participants are followed every three months beginning at eGFR ≤12 mL/min/1.73 m2 and continue through the first 12 months after dialysis start. The study compares trajectories of quality of life, frailty, and other patient-reported outcomes (fatigue, anxiety and depression, general assessment, cognition) between people oriented toward home dialysis and those starting in-center hemodialysis. Analyses will seek predictors of severe decline in these outcomes during advanced CKD follow-up and after dialysis initiation.
Who should consider this trial
Good fit: Adults followed in advanced CKD clinics with eGFR ≤12 mL/min/1.73 m2 who can consent and speak English or French, not planning conservative care or imminent transplant, and with limited prior dialysis exposure are ideal candidates.
Not a fit: Patients planning conservative management, with planned kidney transplant within six months, with severe cognitive or psychiatric inability to consent, with prior long-term dialysis, or with life expectancy under six months are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could help patients and clinicians set realistic expectations about quality of life and frailty changes after starting home versus in-center dialysis and guide modality decisions.
How similar studies have performed: Most prior research on dialysis modality has emphasized mortality and hospitalizations rather than PROMs and frailty, so directly comparable evidence on PROM trajectories is limited and this approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Montreal, Quebec
- Hôpital Maisonneuve-Rosemont — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Annie-Claire Nadeau-Fredette, MD — Ciusss de L'Est de l'Île de Montréal
- Study coordinator: Émilie Robitaille, Bac Sc. Inf.
- Email: emilie.robitaille.cemtl@ssss.gouv.qc.ca
- Phone: 514-252-3400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.