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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ciusss de L'Est de l'Île de Montréal

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Kidney Foundation of Canada

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 13, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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