Transitioning to Home or In-center Dialysis
ConditionChronic Kidney Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCiusss de L'Est de l'Île de Montréal
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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,
Trial population
Adults followed in advanced chronic kidney disease clinics and their caregivers will be recruited from 12 academic centers across Canada
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Exposure: Home dialysis or facility-hemodialysis
Other interventionInitiation of dialysis with home dialysis (peritoneal dialysis or home hemodialysis) or facility-hemodialysis
Treatment groups
420 Participants
are divided into 4 treatment groupsGroup A: Patient - Home Dialysis1 intervention
Group B: Patient - Facility Hemodialysis1 intervention
Group C: Caregivers - Home dialysis1 intervention
Group D: Caregivers - Facility Hemodialysis1 intervention
Trial outcomes
Primary outcomes
1
Change in Kidney Disease Quality of Life - 36 (KDQOL-36) - Patients
Scale from 0-100 (0=poor , 100 = excellent )
Time frame
From study inclusion until 12-months after dialysis start.2
Change in 'ZARIT' burden Interview (ZBI) - Caregivers
Scale 0-88 (0=no/little burden, 88 = severe burden)
Time frame
From study inclusion until 12-months after dialysis start.Secondary outcomes
1
Change in Fried Frailty phenotype
5 components (slowness, weakness, weight loss, low physical activity, exhaustion) with classification as no-frail, pre-frail or frail
Time frame
From study inclusion until 12-months after dialysis start.2
Change in Clinical Frailty Scale
Scale 1 (very fit) to 9 (terminally ill)
Time frame
From study inclusion until 12-months after dialysis start.3
Change in Hospital Anxiety and Depression - Patients
14-item scale (7 anxiety, 7 depression) with score ≥8 used as cut-off for increased risk of depression and anxiety
Time frame
From study inclusion until 12-months after dialysis start.4
Change in Short-form (SF)-36 - Caregivers
Scale from 0-100 (0=poor , 100 = excellent )
Time frame
From study inclusion until 12-months after dialysis start.Other outcomes
1
Semi-structured interviews with patients and caregivers
2 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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ciusss de L'Est de l'Île de Montréal
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
The Kidney Foundation of Canada
Collaborator
Source ClinicalTrials.gov