To analyse the effects of home dialysis - both peritoneal dialysis (PD) and (nocturnal) home haemodialysis - on quality of life, clinical outcomes (anaemia control, hospitalisation, mortality etc.) and total costs compared with in-centre…
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- To compare quality of life between patients on home dialysis - both PD and
home (nocturnal) HD - and patients treated with conventional in-centre HD.
Secondary outcome
- To compare standard clinical outcome parameters (blood pressure, haemoglobin
and phosphate control, protein energy wasting) in home dialysis patients, with
those in a comparison group of patients treated with conventional in-centre HD;
- To analyse the incidence and causes of technique failure of home dialysis -
both PD and home (nocturnal) HD;
- To compare infectious and non-infectious hospitalisation (rate, time to first
hospitalisation and length of hospital stay) between patients on home dialysis
and patients treated with conventional in-centre HD;
- To compare the mortality rate between patients on home dialysis and patients
treated with conventional in centre-HD;
- To compare total costs in home dialysis compared to conventional in-centre
HD, in order to determine cost-effectiveness of home dialysis;
- To analyse experiences of caregivers and caregiver burden.
Background summary
The percentage of patients treated with a form of home dialysis (peritoneal
dialysis and home haemodialysis combined) is steadily decreasing over the past
15 years in the Netherlands, from 33% in 2002 to 18% in 2017. Also, there is
remarkable practice variation in the percentage of home-dialysis-treated
patients in Dutch dialysis centres. Both past performance and practice
variation indicate an underuse of home-based dialysis. Patients treated at home
might obtain greater freedom from managing their own treatment, presuming
positive effects on quality of life. On the other hand, the dialysis population
has changed during the last decade. Young patients often undergo pre-emptive
kidney transplantation, thus the dialysis population consists of older patients
with more comorbidities.
This study is designed to study long-term effects of home dialysis in the
current dialysis population.
Study objective
To analyse the effects of home dialysis - both peritoneal dialysis (PD) and
(nocturnal) home haemodialysis - on quality of life, clinical outcomes (anaemia
control, hospitalisation, mortality etc.) and total costs compared with
in-centre haemodialysis (HD). In addition, the course of caregiver experience
will be assessed.
Study design
A prospective multicentre observational cohort study of all incident patients
that start either peritoneal dialysis or (nocturnal) home haemodialysis between
20-12-2017 and 31-12-2022, with registration of quality of life. In addition
clinical outcomes (blood pressure control, mortality etc.) and total costs,
will be included as secondary endpoints in comparison to a group of patients
that start conventional in-centre HD. In addition, caregivers of patients will
be included to asses caregiver experience for home and in-centre hemodialysis.
The intended follow-up is 12-72 months with expected end of the study on
31-12-2023.
Study burden and risks
There is no burden or risk associated with participation to this study due to
design if this study (observational).
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Patient
- Age > 18 years
- Indication to start with RRT
- Willingness to start with a form of RRT
Caregiver
- The subject must care for a partner, family member, friend or a loved one
with end-stage kidney disease that is treated by dialysis therapy and is
included into the DOMESTICO study
- The subject must be 18 years and older
Exclusion criteria
Patient
- unwillingness to provide informed consent
- life expectancy < 3 months
- expected renal transplantation < 3 months
- unable to fill in questionnaires (including active cognitive disease, active
psychiatric disorder or language barrier other than the languages provided)
Caregiver
- Caregivers who do not provide informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL63277.029.17 |
| OMON | NL-OMON23350 |