Transitioning to Home or In-center Dialysis

Chronic Kidney Diseases Clinical Trial

— TRANSIT-CARE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05989659
• Other study ID #: 2022_2973
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: December 30, 2027

Study information

• Verified date: July 2023
• Source: Ciusss de L'Est de l'Île de Montréal
• Contact: Karine Chaussé
• Phone: 514-252-3400
• Email: karine.chausse.cemtl[@]ssss.gouv.qc.ca
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: December 30, 2027
• Est. primary completion date: December 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Exposure: Home dialysis or facility-hemodialysis
Initiation of dialysis with home dialysis (peritoneal dialysis or home hemodialysis) or facility-hemodialysis

Locations

Country	Name	City	State
Canada	Hôpital Maisonneuve-Rosemont	Montréal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Ciusss de L'Est de l'Île de Montréal	Canadian Institutes of Health Research (CIHR), The Kidney Foundation of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Semi-structured interviews with patients and caregivers	2 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.
Primary	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.
Primary	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	Change in Fried Frailty phenotype	5 components (slowness, weakness, weight loss, low physical activity, exhaustion) with classification as no-frail, pre-frail or frail	From study inclusion until 12-months after dialysis start.
Secondary	Change in Clinical Frailty Scale	Scale 1 (very fit) to 9 (terminally ill)	From study inclusion until 12-months after dialysis start.
Secondary	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	From study inclusion until 12-months after dialysis start.
Secondary	Change in Short-form (SF)-36 - Caregivers	Scale from 0-100 (0=poor , 100 = excellent )	From study inclusion until 12-months after dialysis start.