The primary objective of the current study is to determine the relevance, feasibility and strain for patients of the INPACT protocol.
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study outcome of the current study is relevance, feasibility and
strain for patients of the INPACT protocol, as felt by the participants
themselves (and as perceived by their parents too, for children < 18 years of
age). Semi-structured interviews will be conducted by telephone to collect
these data.
We will also systematically record: the number of approached patients who
declined participation, reasons for non-participation, and % completion of the
study protocol by participants (completion and response rates).
Based on these data, feasibility for enrolment of sufficiently large samples
for the intervention study (the INPACT study) will be determined and the study
protocol will adjusted if necessary.
Secondary outcome
Neurocognitive functioning will be assessed by neuropsychological test
administration.
Medical parameters are derived from the medical records.
Brain structure and activity will be measured with MRI-scans (including DTI)
and qEEG recording.
Adaptive functioning, behavior, health perception, quality of life, sleep and
sociodemographic background will be assessed by a variety of questionnaires.
Background summary
Cognitive impairment is a well-recognized disabling problem in children and
adolescents with childhood onset chronic kidney disease (CKD). In CKD,
decreased health related quality of life (HRQoL), delayed autonomy development
and poorer adaptive functioning is also commonly found. Little is known on the
mechanisms underlying cognitive impairment in CKD, nor on how cognition
estimates the latter three concepts. More specifically, so far it is not clear
what the effects of the disease (e.g. concentrations of uremic toxins) itself
are, or how different strategies of renal replacement therapy (i.e. dialysis
and renal transplantation) impact on cognition. We designed a longitudinal
multicenter study in order to investigate substrates for cognitive
dysfunctioning, to explore the effects of changes in renal replacement therapy
on cognitive functioning and to analyze how cognitive dysfunctioning percolates
adaptive functioning, behavior, health perception and HRQoL in childhood and
young adult onset CKD, the so-called INPACT study.
Study objective
The primary objective of the current study is to determine the relevance,
feasibility and strain for patients of the INPACT protocol.
Study design
The design of this feasibility study is a cross-sectional, observational
study.
Study burden and risks
Participants spent approximately 6 hours in our hospital. During their visit
they will undergo neuropsychological test administration, MRI-scanning
(including DTI), and qEEG-registration. Beforehand, they fill out questionnaire
online (www.hetklikt.nu) from home. Afterwards a semi-structured interview will
be held by telephone. EEG and MRI measurements are non-invasive and
participants will be thoroughly screened and prepared for the measurements.
Children are able to practice the scanning in a mock scanner prior to the
actual MRI scan. During the MRI scan, participants can wear earplugs, listen to
music or they can play a movies of their own choice to make the scanning as
comfortable as possible.
In all, risks of this non-therapeutic study are negligible and the burden is
object of study.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Inclusioncriteria for patients with CKD:
* Patients with CKD 4-5/ESRD or ESRD patients who underwent renal transplantation at least one years ago.
* aged 8-30 years.
* Sufficient visual and hearing acuity
* Dutch language fluency
* Willingness to give informed consent;Inclusioncriteria for three patients with familial uremia:
* Diagnosis of familial uremia.
* age 12 to 50 years
* Sufficient visual and hearing acuity
* Dutch language fluency
* Willingness to give informed consent;Healthy controls must meet all of the following criteria
* Sibling of the candidate, healthy classmate or close friend of the CKD patient.
* No diagnosis of CKD, or other chronic disease with primary or secondary CNS involvement
* Informed consent obtained from the participant or legal guardian if the participant is below 18 years
* age 8-30 year
* Sufficient visual and hearing acuity
* Dutch language fluency
* Willingness to give informed consent
Exclusion criteria
For both patients and healthy controls:
* Pre-existing documented cognitive impairment
* Active, uncontrolled psychiatric illness
* Substance abuse
* A history of cerebrovascular disease (either transitory ischaemic attack or cerebrovascular accident)
* Brain injury
* Epilepsy
* Diabetes mellitus
* Patients will be excluded from MRI scanning in case of MR contraindications, including implanted active devices or objects (e.g. cardiac pacemaker, implantable defibrillator, medication pump, intracranial aneurysm clips, cochlear implant and other implants), metal splinters near sensitive organs (e.g. eye, brain or lungs) or claustrophobia. They are eligible to participate in the other measurements of the study protocol.
* Any condition that can be expected to interfere with complete follow-up
* Patients participating in group 1 of the ALLEGRO trial (adult patients)
* HLA-identical family transplantations
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 | NL61708.018.17 |