Transitioning to Home or In-center Dialysis (TRANSIT-CARE)

February 12, 2025 updated by: Ciusss de L'Est de l'Île de Montréal

Transitioning Patients with Advanced Chronic Kidney Disease to Home or In-center Dialysis: Understanding the Experience and Quality of Life for Patients and Their Caregivers

For people with advanced kidney disease, deciding which type of dialysis is best can be challenging. Studies have shown that quality of life is very important to patients. It is thought that the quality of life of people receiving their dialysis at home may be better than the one of people receiving dialysis in a hospital. However, how the start of dialysis changes the quality of life of people who choose home dialysis in comparison to people choosing dialysis in a hospital is still unknown.

TRANSIT-CARE is a prospective mixed methods study following adult with advanced kidney disease who progress to dialysis and receive home or hospital-based dialysis. This study aims to examine the trajectory and change in patients' quality of life and their frailty status (health, mobility and function) before start of dialysis and up to 12-month after start. Differences between people doing home dialysis and hospital-based dialysis will be assesses taking into account people's characteristics including their gender and socio-demographics characteristics. The study will include questionnaires to measure quality of life and tools to evaluate frailty. Additionally, semi-structured interviews will be done with a diverse group of patients and caregivers before and after the initiation of dialysis to better understand their experience of transitioning to dialysis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Home dialysis has been encouraged due to its clinical benefits and lower costs, leading to increased use in recent years, even among patients with a high comorbidity burden and frailty severity. Health-related quality of life (HRQoL) is reduced in patients receiving dialysis, although patients treated with home dialysis may have relatively better patient-reported outcome measures (PROMs), than those on in-center dialysis. As the home dialysis population expands to include patients with a high frailty severity, it is unknown if these benefits are preserved. More importantly, data lacks on how the transition to home or in-center dialysis is experienced by patients and caregivers and whether changes in HRQoL and frailty impact this experience.

Objectives

  1. Determine and compare the trajectory of HRQoL, frailty and caregiver burden during the chronic kidney disease (CKD)-to-dialysis transition. (QUANTI)
  2. Examine the experience of participants during their progression from CKD to dialysis. (QUALI)
  3. Understand how HRQoL, frailty, and dialysis modality influence patients' and caregivers' experience of transition. (QUANTI+QUALI)

Design and Research Plan TRANSIT-CARE is a 5-year multicenter mixed-methods study of patients with advanced CKD and their caregivers across 12 Canadian centers, with active patient-partner engagement.

QUANTITATIVE Participant will be followed every 3-months (from estimated glomerular filtration rate [eGFR] <12 mL/min/1.73m2) and up to 12-month after dialysis start (4-week, 3-, 6-,12-month).

Target recruitment: 420 patients / 165 caregivers. Dialysis modality will be defined as the chosen modality at baseline visit, and dichotomized as home dialysis (peritoneal or home hemodialysis) and in-center dialysis.

Changes in PROMs and frailty will be assessed using multivariable mixed linear spline regression analysis with each measure used as a continuous variable adjusted for baseline scores, chosen dialysis modality (exposure), dialysis start (time-dependent variable) and prespecified potential confounders.

QUALITATIVE Semi-structured interviews will be conducted with 30 patients and 30 caregivers (from three centers) before and after dialysis initiation.

Thematic analysis will be used to identify patient and caregiver perceptions of home and in-center dialysis, their reactions to dialysis initiation (e.g., feelings of empowerment or loss, life disruption) and perceived burden for caregivers.

Data integration Data from the qualitative and quantitative components will be integrated at time of analysis using tables and joint displays.

Study Type

Observational

Enrollment (Estimated)

420

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 and their caregivers will be recruited from 12 academic centers across Canada

Description

Inclusion Criteria:

  1. Adults followed in advanced CKD clinic,
  2. estimated glomerular filtration rate (eGFR) <12 mL/min/1.73m2 103,
  3. Have chosen their dialysis modality,
  4. Understand English or French.

Exclusion Criteria:

  1. Orientation toward conservative treatment,
  2. Planned kidney transplantation < 6 months,
  3. Unable to provide consent due to severe cognitive or psychiatric disease,
  4. Previous treatment with dialysis > 3 months,
  5. 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
Patient - Home Dialysis
Patients transitioning to home dialysis
Other: Exposure: Home dialysis or facility-hemodialysis
Initiation of dialysis with home dialysis (peritoneal dialysis or home hemodialysis) or facility-hemodialysis
Patient - Facility Hemodialysis
Patients transitioning to facility hemodialysis
Other: Exposure: Home dialysis or facility-hemodialysis
Initiation of dialysis with home dialysis (peritoneal dialysis or home hemodialysis) or facility-hemodialysis
Caregivers - Home dialysis
Caregivers of patients transitioning to home dialysis
Other: Exposure: Home dialysis or facility-hemodialysis
Initiation of dialysis with home dialysis (peritoneal dialysis or home hemodialysis) or facility-hemodialysis
Caregivers - Facility Hemodialysis
Caregivers of patients transitioning to facility hemodialysis
Other: Exposure: Home dialysis or facility-hemodialysis
Initiation of dialysis with home dialysis (peritoneal dialysis or home hemodialysis) or facility-hemodialysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Kidney Disease Quality of Life - 36 (KDQOL-36) - Patients
Time Frame: From study inclusion until 12-months after dialysis start.
Scale from 0-100 (0=poor , 100 = excellent )
From study inclusion until 12-months after dialysis start.
Change in 'ZARIT' burden Interview (ZBI) - Caregivers
Time Frame: From study inclusion until 12-months after dialysis start.
Scale 0-88 (0=no/little burden, 88 = severe burden)
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 - Patients
Time Frame: From study inclusion until 12-months after dialysis start.
14-item scale (7 anxiety, 7 depression) with score ≥8 used as cut-off for increased risk of depression and anxiety
From study inclusion until 12-months after dialysis start.
Change in Short-form (SF)-36 - Caregivers
Time Frame: From study inclusion until 12-months after dialysis start.
Scale from 0-100 (0=poor , 100 = excellent )
From study inclusion until 12-months after dialysis start.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Semi-structured interviews with patients and caregivers
Time Frame: First interview between study start and dialysis initiation / Second interview between dialysis start and up to 12-month after dialysis start.
2 interviews with patients and caregivers
First interview between study start and dialysis initiation / Second interview between dialysis start and up to 12-month 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

Canadian Institutes of Health Research (CIHR)
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)

January 1, 2023

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

July 28, 2023

First Submitted That Met QC Criteria

August 4, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 12, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022_2973

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.

Clinical Trials on Chronic Kidney Diseases

Clinical Trials on Exposure: Home dialysis or facility-hemodialysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zimbabwe

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe