Clinical trial NCT05646615: Experiences and Health-related Quality of Life of Informal Caregivers of Dialysis Patients
Official title: Experiences and Health-related Quality of Life of Informal Caregivers of Patients Who Start Home Dialysis: a Prospective, Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peritoneal Dialysis
Hemodialysis, Home
Hemodialysis
Quality of Life
Informal Caregivers
Family Caregivers
Renal Replacement Therapy
Kidney Failure, Chronic
Patient Reported Outcome Measures
Keywords: End-Stage Kidney Disease
Informal Caregivers
Quality of Life
Experiences
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: Admiraal de Ruyter Hospital
name: Alrijne Hospital
name: Amphia Hospital
name: St. Antonius Hospital
name: Canisius-Wilhelmina Hospital
name: Catharina Ziekenhuis Eindhoven
name: Deventer Ziekenhuis
name: Dialysis Center Beverwijk
name: Tergooi Hospital
name: Diapriva Dialysis Center, Amsterdam
name: Elkerliek Hospital
name: Flevoziekenhuis
name: Gelre Hospitals
name: Groene Hart Ziekenhuis
name: Haga Hospital
name: Isala
name: Laurentius Hospital
name: Maasstad Hospital
name: Maxima Medical Center
name: Noordwest Ziekenhuisgroep
name: OLVG Oost
name: OLVG West
name: Radboud University Medical Center
name: Reinier de Graaf Groep
name: Rijnstate Hospital
name: Saxenburgh Group
name: Slingeland Hospital
name: UMC Utrecht
name: VieCuri Medical Centre
name: Amsterdam UMC
name: Bernhoven Hospital
name: ZorgSaam
name: Jessa Hospital
First posted: 2022-12-12
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Informal caregivers of patients who are starting dialysis and are included in the DOMESTICO study

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.

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

Primary outcomes:
measure: Changes in positive experiences of the caregiver (PES)
timeFrame: Baseline (start of dialysis), and 6 months and 12 months after start dialysis
Secondary outcomes:
measure: Changes in negative experiences of the caregiver (EDIZ+)
timeFrame: Baseline (start of dialysis), and 6 months and 12 months after start dialysis
measure: Changes in negative experiences of the caregiver (CES-D)
timeFrame: Baseline (start of dialysis), and 6 months and 12 months after start dialysis
measure: Changes in health-related quality of life (HRQOL) (SF-12)
timeFrame: Baseline (start of dialysis), and 6 months and 12 months after start dialysis
measure: Changes in health-related quality of life (HRQOL) (EQ5D-5L)
timeFrame: Baseline (start of dialysis), and 6 months and 12 months after start dialysis
Other outcomes:
measure: Required support
timeFrame: Baseline (start of dialysis), and 6 months and 12 months after start dialysis
Locations:
city: Hasselt
country: Belgium
facility: Jessa Hospital
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep
city: Almere
country: Netherlands
facility: Flevoziekenhuis
city: Alphen Aan Den Rijn
country: Netherlands
facility: Alrijne Hospital
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
city: Amsterdam
country: Netherlands
facility: Diapriva Dialysis Center
city: Amsterdam
country: Netherlands
facility: OLVG Oost
city: Amsterdam
country: Netherlands
facility: OVLG West
city: Apeldoorn
country: Netherlands
facility: Gelre Hosptials
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
city: Beverwijk
country: Netherlands
facility: Dialysis Center Beverwijk
city: Breda
country: Netherlands
facility: Amphia Hospital
city: Delft
country: Netherlands
facility: Reinier de Graaf Group
city: Den Haag
country: Netherlands
facility: Haga Hospital
city: Deventer
country: Netherlands
facility: Deventer Hospital
city: Doetinchem
country: Netherlands
facility: Slingeland Hospital
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
city: Goes
country: Netherlands
facility: Admiraal de Ruyter Hospital
city: Gouda
country: Netherlands
facility: Groene Hart Hospital
city: Hardenberg
country: Netherlands
facility: Saxenburgh Group
city: Helmond
country: Netherlands
facility: Elkerliek Hospital
city: Hilversum
country: Netherlands
facility: Dialysis Center Tergooi
city: Nieuwegein
country: Netherlands
facility: Antonius Hospital
city: Nijmegen
country: Netherlands
facility: Canisius-Wilhelmina Hospital
city: Nijmegen
country: Netherlands
facility: Radboudumc
city: Roermond
country: Netherlands
facility: Laurentius Hospital
city: Rotterdam
country: Netherlands
facility: Maasstad Hospital
city: Terneuzen
country: Netherlands
facility: ZorgSaam
city: Uden
country: Netherlands
facility: Bernhoven Hospital
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Veldhoven
country: Netherlands
facility: Maxima Medical Center
city: Venlo
country: Netherlands
facility: VieCuri Medical Center
city: Zwolle
country: Netherlands
facility: Isala Hospital
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Brigit C van Jaarsveld, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: