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

Chronic Kidney Diseases Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06458322
• Other study ID #: 2022_2844
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Ciusss de L'Est de l'Île de Montréal
• Contact: Émilie Robitaille, Bac Sc. Inf.
• Phone: 514-252-3400
• Email: emilie.robitaille.cemtl[@]ssss.gouv.qc.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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;

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.Our 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. We will use data from this study 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, our 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Home dialysis or In-Center dialysis
Initiation of dialysis with home dialysis (peritoneal dialysis or home hemodialysis) or in-center dialysis (hemodialysis)

Locations

Country	Name	City	State
Canada	Hôpital Maisonneuve-Rosemont	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Ciusss de L'Est de l'Île de Montréal	The Kidney Foundation of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Fried Frailty phenotype	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.
Secondary	Change in Clinical Frailty Scale	Scale 1 (very fit) to 9 (terminally ill)	From study inclusion until 12-months after dialysis start
Secondary	Change in Hospital Anxiety and Depression	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
Secondary	Change in Fatigue	3 items questionnaire to assess fatigue and energy.	From study inclusion until 12-months after dialysis start
Secondary	Change in Cognitive Function (MoCa)	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