Transitioning to Home or In-center Dialysis
TRANSIT-CARE
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
1 other identifier
observational
420
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2023
CompletedFirst Submitted
Initial submission to the registry
July 28, 2023
CompletedFirst Posted
Study publicly available on registry
August 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2027
February 14, 2025
February 1, 2025
4 years
July 28, 2023
February 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Kidney Disease Quality of Life - 36 (KDQOL-36) - Patients
Scale from 0-100 (0=poor , 100 = excellent )
From study inclusion until 12-months after dialysis start.
Change in 'ZARIT' burden Interview (ZBI) - Caregivers
Scale 0-88 (0=no/little burden, 88 = severe burden)
From study inclusion until 12-months after dialysis start.
Secondary Outcomes (4)
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 - Patients
From study inclusion until 12-months after dialysis start.
Change in Short-form (SF)-36 - Caregivers
From study inclusion until 12-months after dialysis start.
Other Outcomes (1)
Semi-structured 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.
Study Arms (4)
Patient - Home Dialysis
Patients transitioning to home dialysis
Patient - Facility Hemodialysis
Patients transitioning to facility hemodialysis
Caregivers - Home dialysis
Caregivers of patients transitioning to home dialysis
Caregivers - Facility Hemodialysis
Caregivers of patients transitioning to facility hemodialysis
Interventions
Initiation of dialysis with home dialysis (peritoneal dialysis or home hemodialysis) or facility-hemodialysis
Eligibility Criteria
Adults followed in advanced chronic kidney disease clinics and their caregivers will be recruited from 12 academic centers across Canada
You may qualify if:
- Adults followed in advanced CKD clinic,
- estimated glomerular filtration rate (eGFR) \<12 mL/min/1.73m2 103,
- Have chosen their dialysis modality,
- 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 months,
- Life expectancy \< 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ciusss de L'Est de l'Île de Montréallead
- Canadian Institutes of Health Research (CIHR)collaborator
- The Kidney Foundation of Canadacollaborator
Study Sites (1)
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Annie-Claire Nadeau-Fredette, MD
CIUSSS de l'Est-de-l'Ile-de-Montréal
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2023
First Posted
August 14, 2023
Study Start
January 1, 2023
Primary Completion (Estimated)
December 30, 2026
Study Completion (Estimated)
December 30, 2027
Last Updated
February 14, 2025
Record last verified: 2025-02