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Clinical Trials/NCT05646615
NCT05646615
Completed
Not Applicable

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

B.C. van Jaarsveld33 sites in 2 countries202 target enrollmentJanuary 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peritoneal Dialysis
Sponsor
B.C. van Jaarsveld
Enrollment
202
Locations
33
Primary Endpoint
Changes in positive experiences of the caregiver (PES)
Status
Completed
Last Updated
last year

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
December 31, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
B.C. van Jaarsveld
Responsible Party
Sponsor Investigator
Principal Investigator

B.C. van Jaarsveld

Principal Investigator

Amsterdam UMC, location VUmc

Eligibility Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Changes in positive experiences of the caregiver (PES)

Time Frame: Baseline (start of dialysis), and 6 months and 12 months after start dialysis

Positive Experiences Scale (PES): a Dutch 8-item validates questionnaire

Secondary Outcomes

  • 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)

Study Sites (33)

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