Quality of Life in Patients Transitioning to Home or In-Center Dialysis (QUALIFY CKD-to-HOME)

NCT06458322 | Recruiting

• 1 other identifier: 2022_2844
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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:

• 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;

Conditions

Chronic Kidney Diseases

Keywords

Chronic Kidney Diseases; Quality of Life; Frailty; Dialysis; Home dialysis; In-center dialysis; Peritoneal dialysis; Home hemodialysis; Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Change in Kidney Disease Quality of Life - 36

  Patients Scale from 0-100 (0 = poor, 100 = excellent).

  From study inclusion until 12-months after dialysis start.

Secondary Outcomes (5)

• Change in Fried Frailty phenotype

  From study inclusion until 12-months after dialysis start.

• Change in Clinical Frailty Scale

  From study inclusion until 12-months after dialysis start

• Change in Hospital Anxiety and Depression

  From study inclusion until 12-months after dialysis start

• Change in Fatigue

  From study inclusion until 12-months after dialysis start

• Change in Cognitive Function (MoCa)

  From study inclusion until 12-months after dialysis start

Study Arms (2)

Home dialysis modality

Participants that determined peritoneal dialysis or home hemodialysis as their modality of treatment.

Other: Home dialysis or In-Center dialysis

In-center dialysis modality

Participants that determined in-center hemodialysis as their modality of treatment.

Other: Home dialysis or In-Center dialysis

Interventions

Home dialysis or In-Center dialysis OTHER

Initiation of dialysis with home dialysis (peritoneal dialysis or home hemodialysis) or in-center dialysis (hemodialysis)

Home dialysis modality; In-center dialysis modality

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults followed in advanced chronic kidney disease clinics recruited from 7 centers across Canada

You may qualify if:

• Adult patients followed in advanced CKD clinic;
• eGFR ≤12 mL/min/1.73m2 96;
• Understand English or French.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead
• The Kidney Foundation of Canada: collaborator

Study Sites (1)

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Frailty

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Annie-Claire Nadeau-Fredette, MD

  Ciusss de L'Est de l'Île de Montréal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Émilie Robitaille, Bac Sc. Inf.

CONTACT

514-252-3400; emilie.robitaille.cemtl@ssss.gouv.qc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 13, 2024
• Study Start: July 1, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

CA (1)