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

February 20, 2026 updated by: Ciusss de L'Est de l'Île de Montréal

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)

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;

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background. Home dialysis is encouraged as the preferred therapy for people starting dialysis across Canada, with increased use of peritoneal dialysis (PD) and home hemodialysis (HHD) for patients with higher comorbidity burden. Dialysis modality selection is primarily a patient-centered choice. Modality selection should be mostly based on lifestyle and personal values. Despite the recognition of this patient-centered decision, most dialysis modality studies are based on mortality, hospitalization, and socioeconomic factors. There is a paucity of data to best inform patients of the expected changes in patient-reported outcomes measures (PROMs) such as quality of life (QoL), and the progression of their frailty status after dialysis initiation.

Objective. This study will fill this knowledge gap and evaluate QoL and frailty trajectories from advanced chronic kidney disease (CKD) to after dialysis initiation, specifically comparing patients choosing home dialysis and in-center hemodialysis (ICHD).

Design and Research Plan. Qualify CKD-to-Home is a prospective cohort study in 7 centers across Canada, with active patient-partner engagement. It is expected that around 200 patients will participate. Effort will be made to keep the ration of patients oriented towards home dialysis versus in-center at 1:2 or less.

Every 3 months participants will be followed, from estimated glomerular filtration rate (eGFR) <12 mL/min/1.73m2 and up to 12 months after dialysis start. They will be ask to complete questionnaires as the Kidney Disease Quality of Life (KDQOL-36), Quality of Life, the Hospital Anxiety and Depression Scale (HADS), the Standardized outcomes in Nephrology (SONG)-HD, Fatigue, the Medical Outcome Study- Social Support Survey (MOS-SSS), Social Support, the Montreal Cognitive assessment (MoCa), Cognitive Function, the Clinical Frailty Scale (CFS), the Fried Frailty Phenotype (FP) and the Gender-Related Variable for Health Research questionnaire (GVHR).

Analyse. Descriptive statistics will be used to report baseline characteristics for all patients. The KDQOL-36 components and domains, CFS, FI, HADS, SONG Fatigue instrument, feeling thermometer and MOCA, will be treated as continuous measures. Relationship between baseline scores will be assessed using Spearman correlation. Within patient changes in QoL, continuous frailty measures (CFS, FI), fatigue, depression & anxiety and general health will be described using generalized linear mixed effects models for repeated measures over time. Within patient changes in the proportion of patients classified as frail (vs. non-frail & pre-frail) using the FP with dichotomization will be analyzed in generalized linear mixed models with logistic links for binary repeated measures outcomes nested within centers. Missing data will be managed using multiple imputation by chained equations prior to proposed analyses.

Future directions. This study will help inform patients with advanced CKD on the trajectory of important patient-centered outcomes after dialysis initiation with different dialysis modality. Data from this study will be used to build on a mixed-methods approach with qualitative interviews of patients / caregiver to extend the reach of our understanding on PROMs (QoL) and frailty changes during the CKD to dialysis transition. Finally, the study results will guide stakeholders in the development of interventions that will mitigate risk of adverse outcomes for home dialysis patients at increased risk, as identified in our study.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Home dialysis modality
Participants that determined peritoneal dialysis or home hemodialysis as their modality of treatment.
Other: Home dialysis or In-Center dialysis
Initiation of dialysis with home dialysis (peritoneal dialysis or home hemodialysis) or in-center dialysis (hemodialysis)
In-center dialysis modality
Participants that determined in-center hemodialysis as their modality of treatment.
Other: Home dialysis or In-Center dialysis
Initiation of dialysis with home dialysis (peritoneal dialysis or home hemodialysis) or in-center dialysis (hemodialysis)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Kidney Disease Quality of Life - 36
Time Frame: From study inclusion until 12-months after dialysis start.
Patients Scale from 0-100 (0 = poor, 100 = excellent).
From study inclusion until 12-months after dialysis start.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fried Frailty phenotype
Time Frame: From study inclusion until 12-months after dialysis start.
5 components (slowness, weakness, weight loss, low physical activity, exhaustion) with classification as no-frail, pre-frail or frail.
From study inclusion until 12-months after dialysis start.
Change in Clinical Frailty Scale
Time Frame: From study inclusion until 12-months after dialysis start
Scale 1 (very fit) to 9 (terminally ill)
From study inclusion until 12-months after dialysis start
Change in Hospital Anxiety and Depression
Time Frame: From study inclusion until 12-months after dialysis start
14 items scale (7 anxiety, 7 depression) with score >8 as cut-off for increased risk of depression and anxiety.
From study inclusion until 12-months after dialysis start
Change in Fatigue
Time Frame: From study inclusion until 12-months after dialysis start
3 items questionnaire to assess fatigue and energy.
From study inclusion until 12-months after dialysis start
Change in Cognitive Function (MoCa)
Time Frame: From study inclusion until 12-months after dialysis start
8 cognitive domains: attention and concentration, executive functions, memory, language, visuo-constructional skills, conceptual thinking, calculations, and orientation with a possible score of 30 points.
From study inclusion until 12-months after dialysis start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ciusss de L'Est de l'Île de Montréal

Collaborators

The Kidney Foundation of Canada

Investigators

  • Principal Investigator: Annie-Claire Nadeau-Fredette, MD, Ciusss de L'Est de l'Île de Montréal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

June 10, 2024

First Submitted That Met QC Criteria

June 10, 2024

First Posted (Actual)

June 13, 2024

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 20, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022_2844

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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