Experiences and Health-related Quality of Life of Informal Caregivers of Dialysis Patients
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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18 years or older
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Jessa Hospital | Hasselt | Belgium | ||
2 | Noordwest Ziekenhuisgroep | Alkmaar | Netherlands | ||
3 | Flevoziekenhuis | Almere | Netherlands | ||
4 | Alrijne Hospital | Alphen Aan Den Rijn | Netherlands | ||
5 | Amsterdam UMC | Amsterdam | Netherlands | ||
6 | Diapriva Dialysis Center | Amsterdam | Netherlands | ||
7 | OLVG Oost | Amsterdam | Netherlands | ||
8 | OVLG West | Amsterdam | Netherlands | ||
9 | Gelre Hosptials | Apeldoorn | Netherlands | ||
10 | Rijnstate Hospital | Arnhem | Netherlands | ||
11 | Dialysis Center Beverwijk | Beverwijk | Netherlands | ||
12 | Amphia Hospital | Breda | Netherlands | ||
13 | Reinier de Graaf Group | Delft | Netherlands | ||
14 | Haga Hospital | Den Haag | Netherlands | ||
15 | Deventer Hospital | Deventer | Netherlands | ||
16 | Slingeland Hospital | Doetinchem | Netherlands | ||
17 | Catharina Hospital | Eindhoven | Netherlands | ||
18 | Admiraal de Ruyter Hospital | Goes | Netherlands | ||
19 | Groene Hart Hospital | Gouda | Netherlands | ||
20 | Saxenburgh Group | Hardenberg | Netherlands | ||
21 | Elkerliek Hospital | Helmond | Netherlands | ||
22 | Dialysis Center Tergooi | Hilversum | Netherlands | ||
23 | Antonius Hospital | Nieuwegein | Netherlands | ||
24 | Canisius-Wilhelmina Hospital | Nijmegen | Netherlands | ||
25 | Radboudumc | Nijmegen | Netherlands | ||
26 | Laurentius Hospital | Roermond | Netherlands | ||
27 | Maasstad Hospital | Rotterdam | Netherlands | ||
28 | ZorgSaam | Terneuzen | Netherlands | ||
29 | Bernhoven Hospital | Uden | Netherlands | ||
30 | UMC Utrecht | Utrecht | Netherlands | ||
31 | Maxima Medical Center | Veldhoven | Netherlands | ||
32 | VieCuri Medical Center | Venlo | Netherlands | ||
33 | Isala Hospital | Zwolle | Netherlands |
Sponsors and Collaborators
- B.C. van Jaarsveld
- Admiraal de Ruyter Hospital
- Alrijne Hospital
- Amphia Hospital
- St. Antonius Hospital
- Canisius-Wilhelmina Hospital
- Catharina Ziekenhuis Eindhoven
- Deventer Ziekenhuis
- Dialysis Center Beverwijk
- Tergooi Hospital
- Diapriva Dialysis Center, Amsterdam
- Elkerliek Hospital
- Flevoziekenhuis
- Gelre Hospitals
- Groene Hart Ziekenhuis
- Haga Hospital
- Isala
- Laurentius Hospital
- Maasstad Hospital
- Maxima Medical Center
- Noordwest Ziekenhuisgroep
- OLVG Oost
- OLVG West
- Radboud University Medical Center
- Reinier de Graaf Groep
- Rijnstate Hospital
- Saxenburgh Group
- Slingeland Hospital
- UMC Utrecht
- VieCuri Medical Centre
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Bernhoven Hospital
- ZorgSaam
- Jessa Hospital
Investigators
- Principal Investigator: Brigit C van Jaarsveld, MD, PhD, Amsterdam UMC, location VUmc
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21OM+003