NCT05989659

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Jan 2023Dec 2027

Study Start

First participant enrolled

January 1, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

February 14, 2025

Status Verified

February 1, 2025

Enrollment Period

4 years

First QC Date

July 28, 2023

Last Update Submit

February 12, 2025

Conditions

Keywords

Chronic Kidney DiseaseQuality of LifeFrailtyHome DialysisPeritoneal DialysisHome HemodialysisHemodialysisMixed Methods

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

Other: Exposure: Home dialysis or facility-hemodialysis

Patient - Facility Hemodialysis

Patients transitioning to facility hemodialysis

Other: Exposure: Home dialysis or facility-hemodialysis

Caregivers - Home dialysis

Caregivers of patients transitioning to home dialysis

Other: Exposure: Home dialysis or facility-hemodialysis

Caregivers - Facility Hemodialysis

Caregivers of patients transitioning to facility hemodialysis

Other: Exposure: Home dialysis or facility-hemodialysis

Interventions

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

Caregivers - Facility HemodialysisCaregivers - Home dialysisPatient - Facility HemodialysisPatient - Home Dialysis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Study Sites (1)

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, ChronicFrailty

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Annie-Claire Nadeau-Fredette, MD

    CIUSSS de l'Est-de-l'Ile-de-Montréal

    PRINCIPAL INVESTIGATOR

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

Locations