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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05646615

Enrollment

202

Registered

2022-12-12

Start date

2018-01-01

Completion date

2023-12-31

Last updated

2024-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

End-Stage Kidney Disease, Informal Caregivers, Quality of Life, Experiences

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Other

Measure	Time frame	Description
Required support	Baseline (start of dialysis), and 6 months and 12 months after start dialysis	Exploratory outcome, assessed by a questionnaire investigating in which domains caregivers would like extra support

Countries

Belgium, Netherlands

Outcome results