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

NCT ID: NCT05646615

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

202 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2023-12-31

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.

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

Keywords

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End-Stage Kidney Disease Informal Caregivers Quality of Life Experiences

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Admiraal de Ruyter Hospital

OTHER

Sponsor Role collaborator

Alrijne Hospital

OTHER

Sponsor Role collaborator

Amphia Hospital

OTHER

Sponsor Role collaborator

St. Antonius Hospital

OTHER

Sponsor Role collaborator

Canisius-Wilhelmina Hospital

OTHER

Sponsor Role collaborator

Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role collaborator

Deventer Ziekenhuis

OTHER

Sponsor Role collaborator

Dialysis Center Beverwijk

UNKNOWN

Sponsor Role collaborator

Tergooi Hospital

OTHER

Sponsor Role collaborator

Diapriva Dialysis Center, Amsterdam

OTHER

Sponsor Role collaborator

Elkerliek Hospital

OTHER

Sponsor Role collaborator

Flevoziekenhuis

OTHER

Sponsor Role collaborator

Gelre Hospitals

OTHER

Sponsor Role collaborator

Groene Hart Ziekenhuis

OTHER

Sponsor Role collaborator

Haga Hospital

OTHER

Sponsor Role collaborator

Isala

OTHER

Sponsor Role collaborator

Laurentius Hospital

UNKNOWN

Sponsor Role collaborator

Maasstad Hospital

OTHER

Sponsor Role collaborator

Maxima Medical Center

OTHER

Sponsor Role collaborator

Noordwest Ziekenhuisgroep

OTHER

Sponsor Role collaborator

OLVG Oost

UNKNOWN

Sponsor Role collaborator

OLVG West

UNKNOWN

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role collaborator

Reinier de Graaf Groep

OTHER

Sponsor Role collaborator

Rijnstate Hospital

OTHER

Sponsor Role collaborator

Saxenburgh Group

UNKNOWN

Sponsor Role collaborator

Slingeland Hospital

OTHER

Sponsor Role collaborator

UMC Utrecht

OTHER

Sponsor Role collaborator

VieCuri Medical Centre

OTHER

Sponsor Role collaborator

Amsterdam UMC

OTHER

Sponsor Role collaborator

Bernhoven Hospital

OTHER

Sponsor Role collaborator

ZorgSaam

UNKNOWN

Sponsor Role collaborator

Jessa Hospital

OTHER

Sponsor Role collaborator

B.C. van Jaarsveld

OTHER

Sponsor Role lead

Responsible Party

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B.C. van Jaarsveld

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Brigit C van Jaarsveld, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC, location VUmc

Locations

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Jessa Hospital

Hasselt, , Belgium

Site Status

Noordwest Ziekenhuisgroep

Alkmaar, , Netherlands

Site Status

Flevoziekenhuis

Almere Stad, , Netherlands

Site Status

Alrijne Hospital

Alphen aan den Rijn, , Netherlands

Site Status

Amsterdam UMC

Amsterdam, , Netherlands

Site Status

Diapriva Dialysis Center

Amsterdam, , Netherlands

Site Status

OLVG Oost

Amsterdam, , Netherlands

Site Status

OVLG West

Amsterdam, , Netherlands

Site Status

Gelre Hosptials

Apeldoorn, , Netherlands

Site Status

Rijnstate Hospital

Arnhem, , Netherlands

Site Status

Dialysis Center Beverwijk

Beverwijk, , Netherlands

Site Status

Amphia Hospital

Breda, , Netherlands

Site Status

Reinier de Graaf Group

Delft, , Netherlands

Site Status

Deventer Hospital

Deventer, , Netherlands

Site Status

Slingeland Hospital

Doetinchem, , Netherlands

Site Status

Catharina Hospital

Eindhoven, , Netherlands

Site Status

Admiraal de Ruyter Hospital

Goes, , Netherlands

Site Status

Groene Hart Hospital

Gouda, , Netherlands

Site Status

Saxenburgh Group

Hardenberg, , Netherlands

Site Status

Elkerliek Hospital

Helmond, , Netherlands

Site Status

Dialysis Center Tergooi

Hilversum, , Netherlands

Site Status

Antonius Hospital

Nieuwegein, , Netherlands

Site Status

Canisius-Wilhelmina Hospital

Nijmegen, , Netherlands

Site Status

Radboudumc

Nijmegen, , Netherlands

Site Status

Laurentius Hospital

Roermond, , Netherlands

Site Status

Maasstad Hospital

Rotterdam, , Netherlands

Site Status

ZorgSaam

Terneuzen, , Netherlands

Site Status

Haga Hospital

The Hague, , Netherlands

Site Status

Bernhoven Hospital

Uden, , Netherlands

Site Status

UMC Utrecht

Utrecht, , Netherlands

Site Status

Maxima Medical Center

Veldhoven, , Netherlands

Site Status

VieCuri Medical Center

Venlo, , Netherlands

Site Status

Isala Hospital

Zwolle, , Netherlands

Site Status

Countries

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Belgium Netherlands

Other Identifiers

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21OM+003

Identifier Type: -

Identifier Source: org_study_id