Experiences and Health-related Quality of Life of Informal Caregivers of Dialysis Patients
- Conditions
- HemodialysisRenal Replacement TherapyPeritoneal DialysisQuality of LifeFamily CaregiversKidney Failure, ChronicPatient Reported Outcome MeasuresInformal CaregiversHemodialysis, Home
- Registration Number
- NCT05646615
- Lead Sponsor
- B.C. van Jaarsveld
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 202
- 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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 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
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
Trial Locations
- Locations (33)
Deventer Hospital
🇳🇱Deventer, Netherlands
Jessa Hospital
🇧🇪Hasselt, Belgium
Noordwest Ziekenhuisgroep
🇳🇱Alkmaar, Netherlands
Flevoziekenhuis
🇳🇱Almere, Netherlands
Alrijne Hospital
🇳🇱Alphen Aan Den Rijn, Netherlands
Amsterdam UMC
🇳🇱Amsterdam, Netherlands
OVLG West
🇳🇱Amsterdam, Netherlands
OLVG Oost
🇳🇱Amsterdam, Netherlands
Dialysis Center Beverwijk
🇳🇱Beverwijk, Netherlands
Saxenburgh Group
🇳🇱Hardenberg, Netherlands
Diapriva Dialysis Center
🇳🇱Amsterdam, Netherlands
Amphia Hospital
🇳🇱Breda, Netherlands
Rijnstate Hospital
🇳🇱Arnhem, Netherlands
Gelre Hosptials
🇳🇱Apeldoorn, Netherlands
Haga Hospital
🇳🇱Den Haag, Netherlands
Reinier de Graaf Group
🇳🇱Delft, Netherlands
Slingeland Hospital
🇳🇱Doetinchem, Netherlands
Admiraal de Ruyter Hospital
🇳🇱Goes, Netherlands
Groene Hart Hospital
🇳🇱Gouda, Netherlands
Catharina Hospital
🇳🇱Eindhoven, Netherlands
Elkerliek Hospital
🇳🇱Helmond, Netherlands
Antonius Hospital
🇳🇱Nieuwegein, Netherlands
Canisius-Wilhelmina Hospital
🇳🇱Nijmegen, Netherlands
Dialysis Center Tergooi
🇳🇱Hilversum, Netherlands
Radboudumc
🇳🇱Nijmegen, Netherlands
Laurentius Hospital
🇳🇱Roermond, Netherlands
Maasstad Hospital
🇳🇱Rotterdam, Netherlands
ZorgSaam
🇳🇱Terneuzen, Netherlands
UMC Utrecht
🇳🇱Utrecht, Netherlands
Bernhoven Hospital
🇳🇱Uden, Netherlands
VieCuri Medical Center
🇳🇱Venlo, Netherlands
Maxima Medical Center
🇳🇱Veldhoven, Netherlands
Isala Hospital
🇳🇱Zwolle, Netherlands