The primary objective is to collect data that can be used to develop a *patient-goal driven* decision aid for patients >= 65 years old regarding the choice between dialysis and KT, using two different approaches (semi-structured interviews and…
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are (1) the treatment goals and expectations
regarding dialysis and KT at baseline, and reflection on these six months and
1.5 year after start of RRT, and (2) prediction model for multiple outcome
variables.
Secondary outcome
-
Background summary
A large proportion of patients with end-stage kidney disease (ESKD) are older
adults. Older adults with ESKD opting for RRT can choose between dialysis and
kidney transplantation (KT), which frequently is a difficult. A decision aid
could support patients and their health care professionals facing this dilemma.
Unfortunately, such a decision aid is not available yet.
Study objective
The primary objective is to collect data that can be used to develop a *patient-
goal driven* decision aid for patients >= 65 years old regarding the choice
between dialysis and KT, using two different approaches (semi-structured
interviews and prediction model development). The secondary objectives of this
study are to determine (1) the change in cognitive status, functional status,
frailty, and quality of life between baseline and 1.5 year after start of RRT,
(2) the incidence of mortality, graft failure, severe infections, surgical
complications, hospitalizations in the first 1.5 year after start of RRT, and
(3) treatment satisfaction and decisional regret six months and 1.5 year after
start of RRT.
Study design
Multicentre prospective cohort study.
Study burden and risks
Participating in this study is without risks. Participants will have three
study visits of about 1* hours. Patients waitlisted for deceased KT can have
more study visits, because the baseline measurements will be repeated every six
months until KT The study procedures do not include any invasive procedures,
clinical tests, laboratory tests, or psychological or psychiatric
investigations.
Henri Dunantstraat 1
's-Hertogenbosch 5223GZ
NL
Henri Dunantstraat 1
's-Hertogenbosch 5223GZ
NL
Listed location countries
Age
Inclusion criteria
• Age >= 65 years old
• Stage 5 CKD: eGFR <15 ml/min/1.73 m2 or treated with RRT
• RRT modality: Waitlisted for first deceased donor KT, or first living donor
KT with surgery scheduled within six weeks, or dialysis as first RRT modality
with start expected within six weeks or maximum of six weeks ago
• Medically fit for both dialysis (HD and/or PD) and KT according to the
patients* nephrologist
Exclusion criteria
• Not able to provide informed consent
• Patients with urgent, unplanned dialysis start that were not previously
counselled about RRT by a nephrologist
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL77777.028.21 |