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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05646615
• Other study ID #: 21OM+003
• Status: Active, not recruiting
• Start date: June 25, 2020
• Est. completion date: December 2023

Study information

• Verified date: March 2023
• Source: Amsterdam UMC, location VUmc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Family Caregivers
• Hemodialysis
• Hemodialysis, Home
• Informal Caregivers
• Kidney Failure, Chronic
• Patient Reported Outcome Measures
• Peritoneal Dialysis
• Quality of Life
• Renal Insufficiency
• Renal Replacement Therapy

Locations

Country	Name	City	State
Belgium	Jessa Hospital	Hasselt
Netherlands	Noordwest Ziekenhuisgroep	Alkmaar
Netherlands	Flevoziekenhuis	Almere
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	Haga Hospital	Den Haag
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	Bernhoven Hospital	Uden
Netherlands	UMC Utrecht	Utrecht
Netherlands	Maxima Medical Center	Veldhoven
Netherlands	VieCuri Medical Center	Venlo
Netherlands	Isala Hospital	Zwolle

Sponsors (34)

Lead Sponsor

Collaborator

B.C. van Jaarsveld

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Admiraal de Ruyter Hospital, Alrijne Hospital, Amphia Hospital, Bernhoven Hospital, Canisius-Wilhelmina Hospital, Catharina Ziekenhuis Eindhoven, Deventer Ziekenhuis, Dialysis Center Beverwijk, Diapriva Dialysis Center, Amsterdam, Elkerliek Hospital, Flevoziekenhuis, Gelre Hospitals, Groene Hart Ziekenhuis, Haga Hospital, Isala, Jessa Hospital, 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, St. Antonius Hospital, Tergooi Hospital, UMC Utrecht, VieCuri Medical Centre, ZorgSaam

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Required support	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
Primary	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	Changes in negative experiences of the caregiver (EDIZ+)	'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
Secondary	Changes in negative experiences of the caregiver (CES-D)	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
Secondary	Changes in health-related quality of life (HRQOL) (SF-12)	12-item Short Form (SF-12): validated questionnaire with eight domains	Baseline (start of dialysis), and 6 months and 12 months after start dialysis
Secondary	Changes in health-related quality of life (HRQOL) (EQ5D-5L)	EuroQol-5D-5L (EQ5D-5L): validated questionnaire with five domains	Baseline (start of dialysis), and 6 months and 12 months after start dialysis