(1) to establish the neuropsychiatric and personality status (symptoms and impairments) (2) to assess the possible determinants of these symptoms and impairments and (3) to examine the impact of these symptoms and impairments on daily lifeā¦
ID
Source
Brief title
Condition
- Demyelinating disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
(1) difference in frequency of self-reported neuropsychiatric symptoms /
disorders and personality characteristics between patients and controls using
the following questionnaires: CES-D, HADS, CNS-LS, PDI-21, MDQ-NL and EPQ-RSS
(2) determinants of neuropsychiatric symptoms / disorders: biological markers
(MRI parameters, family history), disease-related (including EDSS, fatigue,
cognitive functioning and iatrogenic) and individual and psychosocial factors
(demographic, locus of control, coping style, social support and premorbid
personality )
(3) the impact of neuropsychiatric symptoms / disorders on daily life
functioning measured by the FIM and SF-36
Secondary outcome
not applicable
Background summary
Neurobehavioral changes, in different levels of severity, are common in MS
patients and pose a significant burden on quality of life and daily life
functioning, but have been investigated incompletely. Although neuroimaging
data offer important clues as to the pathogenesis of these abnormalities,
psychosocial factors cannot be ignored and emerge as equally important
predictors. Most likely, a complex interplay of biological, illness-related,
behavioral and psychosocial factors contribute to the pathophysiology of most
of them.
Study objective
(1) to establish the neuropsychiatric and personality status (symptoms and
impairments)
(2) to assess the possible determinants of these symptoms and impairments and
(3) to examine the impact of these symptoms and impairments on daily life
functioning in a longitudinal cohort of patients with clinically diagnosed MS
Study design
Prolongation of a prospective longitudinal study.
Consists of the following two parts:
1. prospective observational part: to assess determinants of neuropsychiatric
symptoms/disorders and their impact on daily functioning in MS patients
2. case-control cross-sectional part: comparison of frequencies of
neuropsychiatric symptoms/disorders in patients vs controls
Study burden and risks
participants will need to fill in a number of self-report questionnaires and
will receive one phone call to assess two questionnaires. Hence, no visit to
the research centre/hospital is required. Estimated duration: 2 hours to fill
in the self-reported questionnaires and an additional * hour for the assessment
by telephone. No risk involved, no invasive techniques.
de Boelelaan 1118
Amsterdam 1081HZ
NL
de Boelelaan 1118
Amsterdam 1081HZ
NL
Listed location countries
Age
Inclusion criteria
Patients: definite diagnosis of MS, recruited between 1998-2000, participants in the FuProMS study at the last wave
Controls: people aged 30 to 70 years, same catchment area as the patient base.
Exclusion criteria
Patients: no exclusion criteria
Controls: neurological disorder affecting the CNS.
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 | NL46666.029.13 |