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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- Change in Kidney Disease Quality of Life - 36 (KDQOL-36) - Patients
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Change in Kidney Disease Quality of Life - 36 (KDQOL-36) - Patients
时间窗: From study inclusion until 12-months after dialysis start.
Scale from 0-100 (0=poor , 100 = excellent )
Change in 'ZARIT' burden Interview (ZBI) - Caregivers
时间窗: From study inclusion until 12-months after dialysis start.
Scale 0-88 (0=no/little burden, 88 = severe burden)
次要结局
- Change in Clinical Frailty Scale(From study inclusion until 12-months after dialysis start.)
- Change in Fried Frailty phenotype(From study inclusion until 12-months after dialysis start.)
- Change in Hospital Anxiety and Depression - Patients(From study inclusion until 12-months after dialysis start.)
- Change in Short-form (SF)-36 - Caregivers(From study inclusion until 12-months after dialysis start.)