Peritoneal DialysisNCT05646615
Experiences and Health-related Quality of Life of Informal Caregivers of Dialysis Patients
An observational study of Peritoneal Dialysis and Hemodialysis, Home, run by B.C. van Jaarsveld at 33 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peritoneal Dialysis, Hemodialysis, Home, Hemodialysis
- How many people
- 202 participants
- Where
- 33 sitesin 2 countries
- Study dates
- 1 Jan 2018to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Informal caregivers of patients who are starting dialysis and are included in the DOMESTICO study
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
33 sites in 2 countries.
33 sites in 2 countries
Netherlands32 sites
Noordwest Ziekenhuisgroep
Alkmaar
Flevoziekenhuis
Almere Stad
Alrijne Hospital
Alphen aan den Rijn
Amsterdam UMC
Amsterdam
Diapriva Dialysis Center
Amsterdam
OLVG Oost
Amsterdam
OVLG West
Amsterdam
Gelre Hosptials
Apeldoorn
Rijnstate Hospital
Arnhem
Dialysis Center Beverwijk
Beverwijk
Amphia Hospital
Breda
Reinier de Graaf Group
Delft
Deventer Hospital
Deventer
Slingeland Hospital
Doetinchem
Catharina Hospital
Eindhoven
Admiraal de Ruyter Hospital
Goes
Groene Hart Hospital
Gouda
Saxenburgh Group
Hardenberg
Elkerliek Hospital
Helmond
Dialysis Center Tergooi
Hilversum
Antonius Hospital
Nieuwegein
Canisius-Wilhelmina Hospital
Nijmegen
Radboudumc
Nijmegen
Laurentius Hospital
Roermond
Maasstad Hospital
Rotterdam
ZorgSaam
Terneuzen
Haga Hospital
The Hague
Bernhoven Hospital
Uden
UMC Utrecht
Utrecht
Maxima Medical Center
Veldhoven
VieCuri Medical Center
Venlo
Isala Hospital
Zwolle
About this study
Official title: 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.
Read the 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.
- Conditions
- Peritoneal Dialysis, Hemodialysis, Home, Hemodialysis, Quality of Life, Informal Caregivers, Family Caregivers
- Keywords
- End-Stage Kidney Disease, Informal Caregivers, Quality of Life, Experiences
- Medical subject headings
- Kidney Failure, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in positive experiences of the caregiver (PES)
Positive Experiences Scale (PES): a Dutch 8-item validates questionnaire
Measured: Baseline (start of dialysis), and 6 months and 12 months after start dialysis
Secondary outcomes (4)
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
Measured: Baseline (start of dialysis), and 6 months and 12 months after start dialysis
Changes in negative experiences of the caregiver (CES-D)
Centre for Epidemiologic Studies Depression Scale (CES-D): a 20-item validated questionnaire
Measured: Baseline (start of dialysis), and 6 months and 12 months after start dialysis
Changes in health-related quality of life (HRQOL) (SF-12)
12-item Short Form (SF-12): validated questionnaire with eight domains
Measured: Baseline (start of dialysis), and 6 months and 12 months after start dialysis
Changes in health-related quality of life (HRQOL) (EQ5D-5L)
EuroQol-5D-5L (EQ5D-5L): validated questionnaire with five domains
Measured: Baseline (start of dialysis), and 6 months and 12 months after start dialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start1 Jan 2018
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- B.C. van Jaarsveld
- Sponsor type
- University, hospital or other
- Collaborators
- 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, Amsterdam UMC, Bernhoven Hospital, ZorgSaam, Jessa Hospital
- Responsible party
- Sponsor-investigator, B.C. van Jaarsveld, Amsterdam UMC, location VUmc
- Investigators
- Brigit C van Jaarsveld, MD, PhD, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646615
- Sponsor's protocol ID
- 21OM+003
- Status last verified
- Dec 2024
- First submitted
- 21 Nov 2022
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experiences and Health-related Quality of Life of Informal Caregivers of Patients Who Start Home Dialysis: a Prospective, Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT05646615
- Acronym / sponsor ID
- 21OM+003
- Conditions
- Peritoneal Dialysis, Hemodialysis, Home, Hemodialysis, Quality of Life, Informal Caregivers, Family Caregivers
- Keywords
- End-Stage Kidney Disease, Informal Caregivers, Quality of Life, Experiences
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- B.C. van JaarsveldUniversity, hospital or other
- Collaborators
- 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, Amsterdam UMC, Bernhoven Hospital, ZorgSaam, Jessa Hospital
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Informal caregivers of patients who are starting dialysis and are included in the DOMESTICO study
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
Changes in negative experiences of the caregiver (EDIZ+)
Time frame: 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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brigit C van Jaarsveld, MD, PhD principal investigator
Amsterdam UMC, location VUmc
33 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peritoneal Dialysis and Hemodialysis, Home, run by B.C. van Jaarsveld at 33 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Netherlands, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in positive experiences of the caregiver (PES) (time frame: Baseline (start of dialysis), and 6 months and 12 months after start dialysis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.