The purpose of the study is threefold. First, to describe the course of quality of life after renal transplantation and to identify predictors of (un)succesful adjustment. Second, to investigate intra- and interindividual differences that influence…
ID
Source
Brief title
Condition
- Nephropathies
- Renal and urinary tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Patients quality of life in terms of physical, psychological and social
functioning is the main study parameter.
Secondary outcome
The second endpoint is the the occurrence of complications.
Background summary
There is strong consensus favoring renal transplantation (RT) as the treatment
of choice for End Stage Renal Disease (ESRD) in terms of quality of life (QoL).
Although QoL generally increases, it is still unclear how individual
characteristics contribute to this improvement. A range of factors - medical,
behavioural and psychological - will in concert and in a complex interplay
affect the quality of life of the patient. Medical complications, for example
will affect patients* QoL, but at the same time the occurrence of complications
can at least partly be prevented by strict adherence to the medical regimen.
One of the key goals of research into psychosocial adaptation is to determine
why some people are better able to adjust to new circumstances than others.
Insights in the determinants is necessary to design optimal interventions. The
focus of the current study will therefore be, to identify which of these
variables can reliably predict the quality of life of patients after renal
transplantation.
Study objective
The purpose of the study is threefold. First, to describe the course of quality
of life after renal transplantation and to identify predictors of (un)succesful
adjustment. Second, to investigate intra- and interindividual differences that
influence the process of adjustment and thereby patients* quality of life.
Third, to gain more insight into patients* adherence to medication regimes and
its contribution to complications and rejection.
Study design
This study consists of two parts. In a cohort study patients who have undergone
renal transplantation in the UMCG during the past fifteen years will be
included and assessed once. In the prospective study we will include patients
that are currently on the waiting list for transplantation at one assessment
point before transplantation. To be able to follow the process of adjustment in
time, patients will be assessed again at three, six, twelve and twenty-four
months after transplantation.
Study burden and risks
In order to gain insight in the adaptation process self-report measures will be
employed. Patients have to complete a self-report measure at one time before
transplantation (T0) and four points after transplantation (T1-T4). The
assessments will take approximately 60 minutes at all assessment points.
Patients will be given the opportunity to complete the questionnaires in stages
to minimize the burden on the patient. Total assessment time over a two year
period will be approximately 5 hours. No adverse events should be expected from
participation.
Antonius Deusinglaan 1
9713 AV Groningen
NL
Antonius Deusinglaan 1
9713 AV Groningen
NL
Listed location countries
Age
Inclusion criteria
on waiting list or approved for kidney transplantation
18 years and older
in command of the Dutch language
not visually disabled
Exclusion criteria
18 years or younger
not in command of the Dutch language
visually disabled
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 | NL20647.042.07 |