(1) Evaluate whether stroke patients differ from healthy controls on the experience and the course of subjective cognitive complaints during the first two years after stroke;(2) Evaluate potential predictors for cognitive complaints during the first…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
(1) Cognitive complaints.
(2) cognitive performances.
Secondary outcome
Quality of Life.
Background summary
The cognitive consequences of stroke can be examined either objectively or
subjectively. Most of the research to date has focused on objective cognitive
impairments which are assessed through neuropsychological examination. Less
attention has been devoted to subjective cognitive complaints stroke patients
experience in daily life. It is known from clinical practice and the few
studies that have investigated this issue that many patients have cognitive
complaints after their strokes. It is however unknown whether these complaints
differ from those reported in the healthy population, how they develop over
time, and what the significance of these cognitive complaints is. It is also
not known whether there can be defined specific risk factors for the experience
of cognitive complaints after stroke, how cognitive complaints relate to
cognitive disturbances and whether cognitive complaints affect quality of life.
Study objective
(1) Evaluate whether stroke patients differ from healthy controls on the
experience and the course of subjective cognitive complaints during the first
two years after stroke;
(2) Evaluate potential predictors for cognitive complaints during the first two
years after stroke;
(3) Evaluate the predictive value of subjective cognitive complaints for
current and future cognitive functioning;
(4) Evaluate the effect from cognitive complaints on quality of life.
Study design
The project is a prospective follow-up study. Patients and controls will be
evaluated on subjective and objective variables using questionnaires and/or
neuropsychological examination on four separate occasions: 3 months (T1), 6
months (T2), 12 months (T3), and 24 months (T4) after stroke. T1, T3 and T4
consist of an interview, neuropsychological examination and questionnaires. T2
includes a couple of questionnaires only. The interview and neuropsychological
examination will take place at a test setting: patients will be invited to the
hospital in which they were treated for their stroke; healthy controls will be
invited to the Tilburg University. The questionnaires will be given to the
participants to be filled in at home.
Study burden and risks
The study consists of 4 assessments during 2 years. Three assessments include
an interview and neuropsychological examination (about 2 hours per assessment)
and questionnaires (about 30 minutes per assessment). One assessment includes a
couple of questionnaires only (about 15 minutes). The total burden for
participants is estimated to be 8 hours divided over 4 measurements in 2 years.
The study is non-invasive, there are no specific risks, and participants are
compensated by ¤20,- in total.
The results of the study are relevant for both clinical practice and society.
Stroke is highly prevalent and due to ageing of the population, the number of
stroke patients will increase in the upcoming years. It is the now the leading
cause of chronic disability in adults. Stroke is also related to a reduced
quality of life and high health care consumption. With the results of the study
we will gain more insight into the subjective cognitive complaints of stroke
patients in daily life. This will help clinicians in making a prognosis of
cognitive complaints, which is important for both patients and their relatives.
The results will furthermore be useful in determining and/or developing
adequate treatment for cognitive complaints.
Warandelaan 2
5000 LE Tilburg
NL
Warandelaan 2
5000 LE Tilburg
NL
Listed location countries
Age
Inclusion criteria
Clinical diagnosis of stroke (first or recurrent), ischaemic or intracerebral haemorrhagic.
Age > 18 years.
Sufficient understanding of the Dutch language.
Exclusion criteria
Clinical diagnosis of Transcient Ischemic Attack (TIA) or Subarachnoidal bleeding (SAB).
Premorbid cognitive decline as defined by a IQCODE score >3.6.
Premorbid severe psychiatric or neurological problems.
Communication problems which make neuropsychological examination and/or the use of questionnaires impossible (e.g. blindness, deafness, severe aphasia).
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 | NL31208.008.10 |