Experiences and Health-related Quality of Life of Informal Caregivers of Dialysis Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Experiences and Health-related Quality of Life of Informal Caregivers of Patients Who Start Home Dialysis: a Prospective, Multicenter Cohort Study

Conditions
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Peritoneal Dialysis, Hemodialysis, Home, Hemodialysis, Quality of Life, Informal Caregivers, Family Caregivers, Renal Replacement Therapy, Kidney Failure, Chronic, Patient Reported Outcome Measures

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in positive experiences of the caregiver (PES) | Positive Experiences Scale (PES): a Dutch 8-item validates questionnaire | Baseline (start of dialysis), and 6 months and 12 months after start dialysis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in negative experiences of the caregiver (EDIZ+) | 'Ervaren Druk door Informele Zorg' or Experienced Burden by Informal Care (EDIZ+): a Dutch 15-item validated questionnaire | Baseline (start of dialysis), and 6 months and 12 months after start dialysis | 
| Changes in negative experiences of the caregiver (CES-D) | Centre for Epidemiologic Studies Depression Scale (CES-D): a 20-item validated questionnaire | Baseline (start of dialysis), and 6 months and 12 months after start dialysis | 
| Changes in health-related quality of life (HRQOL) (SF-12) | 12-item Short Form (SF-12): validated questionnaire with eight domains | Baseline (start of dialysis), and 6 months and 12 months after start dialysis | 
| Changes in health-related quality of life (HRQOL) (EQ5D-5L) | EuroQol-5D-5L (EQ5D-5L): validated questionnaire with five domains | Baseline (start of dialysis), and 6 months and 12 months after start dialysis | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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End-Stage Kidney Disease, Informal Caregivers, Quality of Life, Experiences