Transitioning to Home or In-center Dialysis

Study Overview
=================
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.

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.

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

Conditions
-----------------
Chronic Kidney Diseases

Intervention / Treatment
-----------------
* Other: Exposure: Home dialysis or facility-hemodialysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient - Home Dialysis<br>Patients transitioning to home dialysis | Other: Exposure: Home dialysis or facility-hemodialysis<br>* Initiation of dialysis with home dialysis (peritoneal dialysis or home hemodialysis) or facility-hemodialysis<br>|
| Patient - Facility Hemodialysis<br>Patients transitioning to facility hemodialysis | Other: Exposure: Home dialysis or facility-hemodialysis<br>* Initiation of dialysis with home dialysis (peritoneal dialysis or home hemodialysis) or facility-hemodialysis<br>|
| Caregivers - Home dialysis<br>Caregivers of patients transitioning to home dialysis | Other: Exposure: Home dialysis or facility-hemodialysis<br>* Initiation of dialysis with home dialysis (peritoneal dialysis or home hemodialysis) or facility-hemodialysis<br>|
| Caregivers - Facility Hemodialysis<br>Caregivers of patients transitioning to facility hemodialysis | Other: Exposure: Home dialysis or facility-hemodialysis<br>* Initiation of dialysis with home dialysis (peritoneal dialysis or home hemodialysis) or facility-hemodialysis<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| Change in Clinical Frailty Scale | Scale 1 (very fit) to 9 (terminally ill) | 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 | From study inclusion until 12-months after dialysis start. | 
| Change in Short-form (SF)-36 - Caregivers | Scale from 0-100 (0=poor , 100 = excellent ) | From study inclusion until 12-months after dialysis start. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Kidney Disease, Quality of Life, Frailty, Home Dialysis, Peritoneal Dialysis, Home Hemodialysis, Hemodialysis, Mixed Methods