The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Transitioning to Home or In-center Dialysis (TRANSIT-CARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05989659
Recruitment Status : Recruiting
First Posted : August 14, 2023
Last Update Posted : August 14, 2023
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
The Kidney Foundation of Canada
Information provided by (Responsible Party):
Ciusss de L'Est de l'Île de Montréal

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment
Chronic Kidney Diseases Other: Exposure: Home dialysis or facility-hemodialysis

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

  1. Determine and compare the trajectory of HRQoL, frailty and caregiver burden during the chronic kidney disease (CKD)-to-dialysis transition. (QUANTI)
  2. Examine the experience of participants during their progression from CKD to dialysis. (QUALI)
  3. 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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 420 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : January 1, 2023
Estimated Primary Completion Date : December 30, 2026
Estimated Study Completion Date : December 30, 2027

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Patient - Home Dialysis
Patients transitioning to home dialysis
 Other: Exposure: Home dialysis or facility-hemodialysis
Initiation of dialysis with home dialysis (peritoneal dialysis or home hemodialysis) or facility-hemodialysis
Patient - Facility Hemodialysis
Patients transitioning to facility hemodialysis
 Other: Exposure: Home dialysis or facility-hemodialysis
Initiation of dialysis with home dialysis (peritoneal dialysis or home hemodialysis) or facility-hemodialysis
Caregivers - Home dialysis
Caregivers of patients transitioning to home dialysis
 Other: Exposure: Home dialysis or facility-hemodialysis
Initiation of dialysis with home dialysis (peritoneal dialysis or home hemodialysis) or facility-hemodialysis
Caregivers - Facility Hemodialysis
Caregivers of patients transitioning to facility hemodialysis
 Other: Exposure: Home dialysis or facility-hemodialysis
Initiation of dialysis with home dialysis (peritoneal dialysis or home hemodialysis) or facility-hemodialysis


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 )

  2. 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)


Secondary Outcome Measures :
  1. Change in Fried Frailty phenotype [ Time Frame: From study inclusion until 12-months after dialysis start. ]
    5 components (slowness, weakness, weight loss, low physical activity, exhaustion) with classification as no-frail, pre-frail or frail

  2. Change in Clinical Frailty Scale [ Time Frame: From study inclusion until 12-months after dialysis start. ]
    Scale 1 (very fit) to 9 (terminally ill)

  3. Change in Hospital Anxiety and Depression - Patients [ Time Frame: From study inclusion until 12-months after dialysis start. ]
    14-item scale (7 anxiety, 7 depression) with score ≥8 used as cut-off for increased risk of depression and anxiety

  4. Change in Short-form (SF)-36 - Caregivers [ Time Frame: From study inclusion until 12-months after dialysis start. ]
    Scale from 0-100 (0=poor , 100 = excellent )


Other Outcome Measures:
  1. Semi-structured 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. ]
    2 interviews with patients and caregivers


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults followed in advanced chronic kidney disease clinics and their caregivers will be recruited from 12 academic centers across Canada
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05989659


Contacts
Layout table for location contacts
Contact: Karine Chaussé 514-252-3400 ext 3722 karine.chausse.cemtl@ssss.gouv.qc.ca

Locations
Layout table for location information
Canada, Quebec
Hôpital Maisonneuve-Rosemont Recruiting
Montréal, Quebec, Canada, H1T 2M4
Contact: Annie-Claire Nadeau-Fredette, MD    514-252-3400 ext 6141    ac.nadeau-fredette@umontreal.ca   
Contact: Karine Chaussé    514-242-3400 ext 3722    karine.chausse.cemtl@ssss.gouv.qc.ca   
Sponsors and Collaborators
Ciusss de L'Est de l'Île de Montréal
Canadian Institutes of Health Research (CIHR)
The Kidney Foundation of Canada
Investigators
Layout table for investigator information
Principal Investigator: Annie-Claire Nadeau-Fredette, MD CIUSSS de l'Est-de-l'Ile-de-Montréal
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Ciusss de L'Est de l'Île de Montréal
ClinicalTrials.gov Identifier: NCT05989659    
Other Study ID Numbers: 2022_2973
First Posted: August 14, 2023    Key Record Dates
Last Update Posted: August 14, 2023
Last Verified: July 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ciusss de L'Est de l'Île de Montréal:
Chronic Kidney Disease
Quality of Life
Frailty
Home Dialysis
 Peritoneal Dialysis
Home Hemodialysis
Hemodialysis
Mixed Methods
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
 Male Urogenital Diseases
Renal Insufficiency
Chronic Disease
Disease Attributes
Pathologic Processes