Recruiting

Home vs. Hospital Dialysis

Sponsor:

Ciusss de L'Est de l'Île de Montréal

Code:

NCT05989659

Conditions

Chronic Kidney Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Exposure: Home dialysis or facility-hemodialysis

Study Details

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.

Conditions

Chronic Kidney Diseases

Study ID

NCT05989659

Start date

Jan 1, 2023

Status verified date

Feb, 2025

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

420 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Exposure: Home dialysis or facility-hemodialysis

Initiation of dialysis with home dialysis (peritoneal dialysis or home hemodialysis) or facility-hemodialysis

Primary outcome measure

  • Change in Kidney Disease Quality of Life - 36 (KDQOL-36) - Patients [ Time Frame: 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. ]

Central Contacts and Locations

Locations

Hôpital Maisonneuve-Rosemont

Recruiting

Montréal, Quebec, Canada, H1T 2M4

Contacts

More Information

Sponsor

Ciusss de L'Est de l'Île de Montréal

Last update posted

Feb 14, 2025

Last verified

Feb, 2025

Keywords

  • Chronic Kidney Disease
  • Quality of Life
  • Frailty
  • Home Dialysis
  • Peritoneal Dialysis
  • Home Hemodialysis
  • Hemodialysis
  • Mixed Methods

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ciusss de L'Est de l'Île de Montréal on 2025-02-14.