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

March 14, 2023 updated by: B.C. van Jaarsveld

Experiences and Health-related Quality of Life of Informal Caregivers of Patients Who Start Home Dialysis: a Prospective, Multicenter Cohort Study

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Hasselt, Belgium
        • Jessa Hospital
  • Netherlands
      • Alkmaar, Netherlands
        • Noordwest Ziekenhuisgroep
      • Almere, Netherlands
        • Flevoziekenhuis
      • Alphen Aan Den Rijn, Netherlands
        • Alrijne Hospital
      • Amsterdam, Netherlands
        • Amsterdam UMC
      • Amsterdam, Netherlands
        • OLVG Oost
      • Amsterdam, Netherlands
        • Diapriva Dialysis Center
      • Amsterdam, Netherlands
        • OVLG West
      • Apeldoorn, Netherlands
        • Gelre Hosptials
      • Arnhem, Netherlands
        • Rijnstate Hospital
      • Beverwijk, Netherlands
        • Dialysis Center Beverwijk
      • Breda, Netherlands
        • Amphia Hospital
      • Delft, Netherlands
        • Reinier de Graaf Group
      • Den Haag, Netherlands
        • Haga Hospital
      • Deventer, Netherlands
        • Deventer Hospital
      • Doetinchem, Netherlands
        • Slingeland Hospital
      • Eindhoven, Netherlands
        • Catharina Hospital
      • Goes, Netherlands
        • Admiraal de Ruyter Hospital
      • Gouda, Netherlands
        • Groene Hart Hospital
      • Hardenberg, Netherlands
        • Saxenburgh Group
      • Helmond, Netherlands
        • Elkerliek Hospital
      • Hilversum, Netherlands
        • Dialysis Center Tergooi
      • Nieuwegein, Netherlands
        • Antonius hospital
      • Nijmegen, Netherlands
        • Canisius-Wilhelmina Hospital
      • Nijmegen, Netherlands
        • Radboudumc
      • Roermond, Netherlands
        • Laurentius Hospital
      • Rotterdam, Netherlands
        • Maasstad Hospital
      • Terneuzen, Netherlands
        • ZorgSaam
      • Uden, Netherlands
        • Bernhoven Hospital
      • Utrecht, Netherlands
        • UMC Utrecht
      • Veldhoven, Netherlands
        • Máxima Medical Center
      • Venlo, Netherlands
        • Viecuri Medical Center
      • Zwolle, Netherlands
        • Isala Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Informal caregivers of patients who are starting dialysis and are included in the DOMESTICO study

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in positive experiences of the caregiver (PES)
Time Frame: Baseline (start of dialysis), and 6 months and 12 months after start dialysis
Positive Experiences Scale (PES): a Dutch 8-item validates questionnaire
Baseline (start of dialysis), and 6 months and 12 months after start dialysis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in negative experiences of the caregiver (EDIZ+)
Time Frame: 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
Baseline (start of dialysis), and 6 months and 12 months after start dialysis
Changes in negative experiences of the caregiver (CES-D)
Time Frame: 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
Baseline (start of dialysis), and 6 months and 12 months after start dialysis
Changes in health-related quality of life (HRQOL) (SF-12)
Time Frame: Baseline (start of dialysis), and 6 months and 12 months after start dialysis
12-item Short Form (SF-12): validated questionnaire with eight domains
Baseline (start of dialysis), and 6 months and 12 months after start dialysis
Changes in health-related quality of life (HRQOL) (EQ5D-5L)
Time Frame: Baseline (start of dialysis), and 6 months and 12 months after start dialysis
EuroQol-5D-5L (EQ5D-5L): validated questionnaire with five domains
Baseline (start of dialysis), and 6 months and 12 months after start dialysis

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Required support
Time Frame: 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
Baseline (start of dialysis), and 6 months and 12 months after start dialysis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

B.C. van Jaarsveld

Collaborators

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

Investigators

  • Principal Investigator: Brigit C van Jaarsveld, MD, PhD, Amsterdam UMC, location VUmc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2020

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

November 21, 2022

First Submitted That Met QC Criteria

December 1, 2022

First Posted (Actual)

December 12, 2022

Study Record Updates

Last Update Posted (Actual)

March 15, 2023

Last Update Submitted That Met QC Criteria

March 14, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21OM+003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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