Chronic Kidney DiseasesTRANSIT-CARENCT05989659
Transitioning to Home or In-center Dialysis
An observational study of Chronic Kidney Diseases, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Exposure: Home dialysis or facility-hemodialysis
- How many people
- 420 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2023to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults followed in advanced chronic kidney disease clinics and their caregivers will be recruited from 12 academic centers across Canada
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
Annie-Claire Nadeau-Fredette, MD, 514-252-3400 ext. 6141, ac.nadeau-fredette@umontreal.ca
Karine Chaussé, 514-242-3400 ext. 3722, karine.chausse.cemtl@ssss.gouv.qc.ca
About this study
Official title: 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.
Read the 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
- Determine and compare the trajectory of HRQoL, frailty and caregiver burden during the chronic kidney disease (CKD)-to-dialysis transition. (QUANTI)
- Examine the experience of participants during their progression from CKD to dialysis. (QUALI)
- 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.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Exposure: Home dialysis or facility-hemodialysis
- Keywords
- Chronic Kidney Disease, Quality of Life, Frailty, Home Dialysis, Peritoneal Dialysis, Home Hemodialysis, Hemodialysis, Mixed Methods
- Medical subject headings
- Renal Insufficiency, Chronic, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure: Home dialysis or facility-hemodialysisOther
Initiation of dialysis with home dialysis (peritoneal dialysis or home hemodialysis) or facility-hemodialysis
| Study group | Role | What they receive |
|---|---|---|
| Patient - Home Dialysis | Patients transitioning to home dialysis Receives: Other: Exposure: Home dialysis or facility-hemodialysis | |
| Patient - Facility Hemodialysis | Patients transitioning to facility hemodialysis Receives: Other: Exposure: Home dialysis or facility-hemodialysis | |
| Caregivers - Home dialysis | Caregivers of patients transitioning to home dialysis Receives: Other: Exposure: Home dialysis or facility-hemodialysis | |
| Caregivers - Facility Hemodialysis | Caregivers of patients transitioning to facility hemodialysis Receives: Other: Exposure: Home dialysis or facility-hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Kidney Disease Quality of Life - 36 (KDQOL-36) - Patients
Scale from 0-100 (0=poor , 100 = excellent )
Measured: 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)
Measured: From study inclusion until 12-months after dialysis start.
Secondary outcomes (4)
Change in Fried Frailty phenotype
5 components (slowness, weakness, weight loss, low physical activity, exhaustion) with classification as no-frail, pre-frail or frail
Measured: From study inclusion until 12-months after dialysis start.
Change in Clinical Frailty Scale
Scale 1 (very fit) to 9 (terminally ill)
Measured: From study inclusion until 12-months after dialysis start.
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
Measured: From study inclusion until 12-months after dialysis start.
Change in Short-form (SF)-36 - Caregivers
Scale from 0-100 (0=poor , 100 = excellent )
Measured: From study inclusion until 12-months after dialysis start.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Jan 2023
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), The Kidney Foundation of Canada
- Responsible party
- Sponsor
- Investigators
- Annie-Claire Nadeau-Fredette, MD, Principal investigator, CIUSSS de l'Est-de-l'Ile-de-Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989659
- Sponsor's protocol ID
- 2022_2973
- Acronym
- TRANSIT-CARE
- Status last verified
- Feb 2025
- First submitted
- 28 Jul 2023
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05989659
- Acronym / sponsor ID
- TRANSIT-CARE / 2022_2973
- Conditions
- Chronic Kidney Diseases
- Keywords
- Chronic Kidney Disease, Quality of Life, Frailty, Home Dialysis, Peritoneal Dialysis, Home Hemodialysis, Hemodialysis, Mixed Methods
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), The Kidney Foundation of Canada
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Determine and compare the trajectory of HRQoL, frailty and caregiver burden during the chronic kidney disease (CKD)-to-dialysis transition. (QUANTI)
- Examine the experience of participants during their progression from CKD to dialysis. (QUALI)
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patient - Home Dialysis | – | Other: Exposure: Home dialysis or facility-hemodialysisPatients transitioning to home dialysis |
| Patient - Facility Hemodialysis | – | Other: Exposure: Home dialysis or facility-hemodialysisPatients transitioning to facility hemodialysis |
| Caregivers - Home dialysis | – | Other: Exposure: Home dialysis or facility-hemodialysisCaregivers of patients transitioning to home dialysis |
| Caregivers - Facility Hemodialysis | – | Other: Exposure: Home dialysis or facility-hemodialysisCaregivers of patients transitioning to facility hemodialysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults followed in advanced chronic kidney disease clinics and their caregivers will be recruited from 12 academic centers across Canada
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure: Home dialysis or facility-hemodialysisInitiation of dialysis with home dialysis (peritoneal dialysis or home hemodialysis) or facility-hemodialysis | Other | Caregivers - Facility Hemodialysis, Caregivers - Home dialysis, Patient - Facility Hemodialysis, Patient - Home Dialysis |
Primary outcome
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 )
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)
4 secondary outcomes
Change in Fried Frailty phenotype
Time frame: 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.
Change in Hospital Anxiety and Depression - Patients
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Annie-Claire Nadeau-Fredette, MD principal investigator
CIUSSS de l'Est-de-l'Ile-de-Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karine Chaussé (514-252-3400 ext. 3722, karine.chausse.cemtl@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.