Experiences and Health-related Quality of Life of Informal Caregivers of Patients Who Start Home Dialysis: a Prospective, Multicenter Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 202
- 试验地点
- 33
- 主要终点
- Changes in positive experiences of the caregiver (PES)
研究概览
简要总结
The goal of this prospective, observational, multicentre cohort study is to assess the trajectory of the experiences (both positive and negative) and health-related quality of life (HRQOL) of informal caregivers of patients who start home dialysis, and compare these to experiences and HRQOL of informal caregivers of patients who start in-centre hemodialysis. The investigators hypothesise that informal caregivers of home dialysis patients experience more positive experiences, but also more negative experiences, and still have better HRQoL, compared with caregivers of in-centre HD patients. Participants will fill in five different validated questionnaires and questions on required support. Participants are asked to fill in the questionnaires after inclusion (i.e., start of dialysis), and at 6 and 12 months after start dialysis.
详细描述
End-stage kidney disease, the need to start dialysis, and the choice for a home-based treatment or a centre-based treatment does not only have an effect on patients, but also on their informal caregivers like spouses and adult children providing care to the patient. In order to properly inform patients with end-stage kidney disease and their informal caregivers about the start of dialysis therapy and the choice of dialysis modality, it is important to discuss also what the caregiver can expect after the start of dialysis. However, available evidence regarding the course of caregiving experiences after start of dialysis is limited. The aim of this study is to assess the trajectory of the experiences (both positive and negative) and health-related quality of life (HRQoL) of caregivers of patients who start home dialysis, and compare these to experiences and HRQoL of caregivers of patients who start in-centre hemodialysis (HD). The investigators hypothesise that (co-residential) caregivers of home dialysis patients experience more positive experiences, but also more negative experiences, and still have better HRQoL, compared with caregivers of in-centre HD patients.
This study is a prospective, observational, multicentre cohort study which is an extension of the ongoing DOMESTICO study. DOMESTICO is a nationwide study in incident dialysis patients, investigating the effects of home dialysis on HRQoL in relation to clinical outcome and costs, in comparison to in-centre HD. Participants will fill in five different validated questionnaires and questions on required support. Participants are asked to fill in the questionnaires after inclusion (i.e., start of dialysis), and at 6 and 12 months after start dialysis.
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
- 是
入选标准
- •Informal caregivers who care for a partner, family member, friend or loved one with end-stage kidney disease who is starting dialysis therapy and is included in the DOMESTICO study
- •18 years or older
排除标准
- 未提供
结局指标
主要结局
Changes in positive experiences of the caregiver (PES)
时间窗: Baseline (start of dialysis), and 6 months and 12 months after start dialysis
Positive Experiences Scale (PES): a Dutch 8-item validates questionnaire
次要结局
- Changes in negative experiences of the caregiver (EDIZ+)(Baseline (start of dialysis), and 6 months and 12 months after start dialysis)
- Changes in health-related quality of life (HRQOL) (SF-12)(Baseline (start of dialysis), and 6 months and 12 months after start dialysis)
- Changes in health-related quality of life (HRQOL) (EQ5D-5L)(Baseline (start of dialysis), and 6 months and 12 months after start dialysis)
- Changes in negative experiences of the caregiver (CES-D)(Baseline (start of dialysis), and 6 months and 12 months after start dialysis)
研究者
B.C. van Jaarsveld
Principal Investigator
Amsterdam UMC, location VUmc