The main aim of this study is to examine predictors of (changes in) employment status and work absenteeism in relapsing-remitting MS patients and subjects without a chronic disease over a period of three years
ID
Source
Brief title
Condition
- Central nervous system infections and inflammations
- Lifestyle issues
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The outcome variables include changes in employment status (i.e. stable versus
deteriorated) and work absenteeism (i.e. days missed from work during a
specified period) from baseline to endpoint
Secondary outcome
The secondary study parameters include the predictor variables, i.e. cognitive
performance and cognitive complaints, physical ability, psychological
functioning (i.e. anxiety, depression, psychosocial stress, quality of life,
fatigue, empathy, personality traits and coping strategies), gene set data,
polygenetic risk score, and type of immunomodulatory treatment.
Background summary
Multiple Sclerosis (MS) is the most common cause of disability in young and
middle-aged adults. At this stage in life most people are in the midst of their
working career. However, the majority of MS patients are unable to retain
employment within 10 years from disease onset. Leading up to unemployment, many
may experience a reduction in hours or work responsibilities and increased time
missed from work. Cross-sectional studies have identified several factors
associated with decreased employment status and work absenteeism in MS. These
include cognitive impairments, physical dysfunction, psychological problems and
type of treatment. Prospective studies are rare, or take into account a limited
number of factors. By examining possible predictors of (changes in) employment
status and work absenteeism in patients with relapsing-remitting MS and
subjects without a chronic disease during a period of three years, we aim to
provide useful information about preventative factors for physicians,
psychologists and vocational rehabilitation therapists.
Study objective
The main aim of this study is to examine predictors of (changes in) employment
status and work absenteeism in relapsing-remitting MS patients and subjects
without a chronic disease over a period of three years
Study design
An observational, prospective cohort study
Study burden and risks
At four time points (i.e. baseline, after 1, 2 and 3 years) participants will
be asked to complete questionnaires (1-2 hours), and undergo neurological (half
an hour) and neuropsychological examinations (2 hours). After 6 months
participants will be asked to complete questionnaires without undergoing a
neurological or neuropsychological examination. The subjects without a chronic
disease will undergo a neuropsychological examination (2 hours) at baseline
only. At four time points (i.e. baseline, after 1, 2 and 3 years) the subjects
without a chronic disease will be asked to complete questionnaires (1-2 hours).
Several MS-specific questionnaires, questionnaires for caregivers and the
neurological examination will not be part of their examination. The
questionnaires can be completed at home, and contain questions about the
patient's cognitive functioning, work situation and psychological functioning.
The neurological and neuropsychological examinations will be performed on the
same day (including as many breaks as necessary) and should preferably take
place at the outpatient clinic where the patient is treated. If this is not
possible, testing can take place at the patient*s home. A subset of MS patients
will be approached for the interviews (appendix 5 protocol), and/or will be
asked to provide a blood sample (10 ml) for the genome wide association study
(appendix 7 protocol).
For the subjects without a chronic disease testing will take place at their
homes, at the National MS Foundation, or Leiden University.
The examinations will be performed by a research nurse or psychologist and a
neurologist in training. There are no risks involved. The participants may not
benefit individually, but the study should reveal typical patterns leading to
unemployment in MS and aims to identify preventative factors.
Mathenesserlaan 378
Rotterdam 3023 HB
NL
Mathenesserlaan 378
Rotterdam 3023 HB
NL
Listed location countries
Age
Inclusion criteria
-Patients with a diagnosis of relapsing-remitting Multiple Sclerosis according to the McDonald criteria 2010 and healthy controls not diagnosed with any neurological, psychiatric or other chronic disorder
-18 years or older
-currently employed or within 3 years since their last employment
Exclusion criteria
-co morbid psychiatric or neurological disorders
-substance abuse
-MS relapse within 1 month prior to the study visit
-unable to speak and/or read Dutch
-neurological impairment that might interfere with cognitive testing (e.g. upper limb weakness, dysarthria, vision worse than 20/70)
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 | NL43098.008.12 |