Experiences and Health-related Quality of Life of Informal Caregivers of Dialysis Patients
1 other identifier
observational
202
2 countries
33
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2018
Longer than P75 for all trials
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2018
CompletedFirst Submitted
Initial submission to the registry
November 21, 2022
CompletedFirst Posted
Study publicly available on registry
December 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedDecember 12, 2024
December 1, 2024
6 years
November 21, 2022
December 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Changes in negative experiences of the caregiver (EDIZ+)
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
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
Other Outcomes (1)
Required support
Baseline (start of dialysis), and 6 months and 12 months after start dialysis
Eligibility Criteria
Informal caregivers of patients who are starting dialysis and are included in the DOMESTICO study
You may qualify if:
- 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
- years or older
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- B.C. van Jaarsveldlead
- Admiraal de Ruyter Hospitalcollaborator
- Alrijne Hospitalcollaborator
- Amphia Hospitalcollaborator
- St. Antonius Hospitalcollaborator
- Canisius-Wilhelmina Hospitalcollaborator
- Catharina Ziekenhuis Eindhovencollaborator
- Deventer Ziekenhuiscollaborator
- Dialysis Center Beverwijkcollaborator
- Tergooi Hospitalcollaborator
- Diapriva Dialysis Center, Amsterdamcollaborator
- Elkerliek Hospitalcollaborator
- Flevoziekenhuiscollaborator
- Gelre Hospitalscollaborator
- Groene Hart Ziekenhuiscollaborator
- Haga Hospitalcollaborator
- Isalacollaborator
- Laurentius Hospitalcollaborator
- Maasstad Hospitalcollaborator
- Maxima Medical Centercollaborator
- Noordwest Ziekenhuisgroepcollaborator
- OLVG Oostcollaborator
- OLVG Westcollaborator
- Radboud University Medical Centercollaborator
- Reinier de Graaf Groepcollaborator
- Rijnstate Hospitalcollaborator
- Saxenburgh Groupcollaborator
- Slingeland Hospitalcollaborator
- UMC Utrechtcollaborator
- VieCuri Medical Centrecollaborator
- Amsterdam UMCcollaborator
- Bernhoven Hospitalcollaborator
- ZorgSaamcollaborator
- Jessa Hospitalcollaborator
Study Sites (33)
Jessa Hospital
Hasselt, Belgium
Noordwest Ziekenhuisgroep
Alkmaar, Netherlands
Flevoziekenhuis
Almere Stad, Netherlands
Alrijne Hospital
Alphen aan den Rijn, Netherlands
Amsterdam UMC
Amsterdam, Netherlands
Diapriva Dialysis Center
Amsterdam, Netherlands
OLVG Oost
Amsterdam, Netherlands
OVLG West
Amsterdam, Netherlands
Gelre Hosptials
Apeldoorn, Netherlands
Rijnstate Hospital
Arnhem, Netherlands
Dialysis Center Beverwijk
Beverwijk, Netherlands
Amphia Hospital
Breda, Netherlands
Reinier de Graaf Group
Delft, Netherlands
Deventer Hospital
Deventer, Netherlands
Slingeland Hospital
Doetinchem, Netherlands
Catharina Hospital
Eindhoven, Netherlands
Admiraal de Ruyter Hospital
Goes, Netherlands
Groene Hart Hospital
Gouda, Netherlands
Saxenburgh Group
Hardenberg, Netherlands
Elkerliek Hospital
Helmond, Netherlands
Dialysis Center Tergooi
Hilversum, Netherlands
Antonius Hospital
Nieuwegein, Netherlands
Canisius-Wilhelmina Hospital
Nijmegen, Netherlands
Radboudumc
Nijmegen, Netherlands
Laurentius Hospital
Roermond, Netherlands
Maasstad Hospital
Rotterdam, Netherlands
ZorgSaam
Terneuzen, Netherlands
Haga Hospital
The Hague, Netherlands
Bernhoven Hospital
Uden, Netherlands
UMC Utrecht
Utrecht, Netherlands
Maxima Medical Center
Veldhoven, Netherlands
VieCuri Medical Center
Venlo, Netherlands
Isala Hospital
Zwolle, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brigit C van Jaarsveld, MD, PhD
Amsterdam UMC, location VUmc
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 21, 2022
First Posted
December 12, 2022
Study Start
January 1, 2018
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
December 12, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share