The goals of this study is twofold:At first we want to gain insight in neurocognitive functioning of children and adolescents (12-18 year) with JSLE.Secondly, we want to adapt and validate a Dutch translation of a short "Quality Life…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Central nervous system vascular disorders
- Cognitive and attention disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The studieparameters are
1) Inventarisation of cognitive functioning of patients with JSLE, using
standard tests on intelligence, memory, learning, concentration, executive
functions, and rate
2) valdiation of a Dutch translation of a Quality of Life Questionnaire, th
so-called SMILEY©, in patients with JSLE
Secondary outcome
not applicable
Background summary
Systemic lupus erythematosus (SLE) is a rare, chronic multisystem autoimmune
disaese, with involvement of the central nerve system. Is is not known if, and
how often SLE disease activity in children and adolsecents leads to cognitive
functioning disorders. In this cross-sectional studie neuropsychological
disorders in children with Juvenile SLE (JSLE) will be analyzed.
Due to the multiorgan involvement and the chronicity JSLE disease activity may
have impact on several aspects of quality of life. Recently, a short 'Quality
of Life' questionnaire was developed, using smiley's©. This questionnaire was
validated for English-speaking countries. Translation and validation of the
questionnaire into other languages will be of use to compare outcome of
treatment strategie in JSLE worldwide.
Study objective
The goals of this study is twofold:
At first we want to gain insight in neurocognitive functioning of children and
adolescents (12-18 year) with JSLE.
Secondly, we want to adapt and validate a Dutch translation of a short "Quality
Life Questionnaire" designed for children and adolescents (12-18 year) with
JSLE.
Study design
Neuropsychology: Study parameters will be derived from standard tests on
intelligence, memory, learning, concentration, executive functions, and rate.
It is a once-only session, and will take about 5 hours, including a 20-30
minute break.
The first Quality of Life Questionnaire will be completed during an outpatient
contact. It is ment for validation of the QOL scales. It will take about 30
minutes for the first questionnaire for both patient and parents. The
consecutive questionnaires will take about 10 minutes each, and will be
repeated during the outpatient visits for 2 years.
Study burden and risks
The extent of the burden of both neuropsychologicla testing and of the Quality
of Life questionnaire is minimal, only time investment.
Lundlaan 6
3584 EA Utrecht
NL
Lundlaan 6
3584 EA Utrecht
NL
Listed location countries
Age
Inclusion criteria
.age 12-18 years
.diagnosis of SLE according to ACR criteria
.capable of reading and understanding Dutch language
.informed consent (children < 16 years, also parental informed consent)
Exclusion criteria
.unable to read or understand the Dutch language
.physically unable to undergo neuropsychological investigation
.refusal of informer 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
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL25638.041.08 |