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

Sponsor
B.C. van Jaarsveld (Other)
Overall Status
Recruiting
CT.gov ID
NCT05646615
Collaborator
Admiraal de Ruyter Hospital (Other), Alrijne Hospital (Other), Amphia Hospital (Other), St. Antonius Hospital (Other), Canisius-Wilhelmina Hospital (Other), Catharina Ziekenhuis Eindhoven (Other), Deventer Ziekenhuis (Other), Dialysis Center Beverwijk (Other), Tergooi Hospital (Other), Diapriva Dialysis Center, Amsterdam (Other), Elkerliek Hospital (Other), Flevoziekenhuis (Other), Gelre Hospitals (Other), Groene Hart Ziekenhuis (Other), Haga Hospital (Other), Isala (Other), Laurentius Hospital (Other), Maasstad Hospital (Other), Maxima Medical Center (Other), Noordwest Ziekenhuisgroep (Other), OLVG Oost (Other), OLVG West (Other), Radboud University Medical Center (Other), Reinier de Graaf Groep (Other), Rijnstate Hospital (Other), Saxenburgh Group (Other), Slingeland Hospital (Other), UMC Utrecht (Other), VieCuri Medical Centre (Other), Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other), Bernhoven Hospital (Other), ZorgSaam (Other), Jessa Hospital (Other)
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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.

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

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Experiences and Health-related Quality of Life of Informal Caregivers of Patients Who Start Home Dialysis: a Prospective, Multicenter Cohort Study
Actual Study Start Date :
Jun 25, 2020
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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

  1. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
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.
Responsible Party:
B.C. van Jaarsveld, Principal Investigator, Amsterdam UMC, location VUmc
ClinicalTrials.gov Identifier:
NCT05646615
Other Study ID Numbers:
  • 21OM+003
First Posted:
Dec 12, 2022
Last Update Posted:
Dec 12, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by B.C. van Jaarsveld, Principal Investigator, Amsterdam UMC, location VUmc
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 12, 2022