The main objective of this study is to determine how well the Multiple Screener© can differentiate between patients with no cognitive deficits, mild cognitive deficits and cognitive impairment. Additionally, we aim to confirm the observed accuracy…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Demyelinating disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome measures are: Sensitivity, specificity, negative and positive
predictive value of Multiple Screener© compared to the gold standard (MACFIMS).
Secondary outcome
Secondary outcome measures include the test-retest reliability of the Multiple
Screener© and the relationships between cognitive functioning (as measured with
the Multiple Screener© and the MACFIMS test batter) and psychological,
work-related and qualty of life measures. Additionally, the experiences with
the discussion and assessment of cognitive functioning are secondary outcome
measures.
Background summary
Up to 70% of patients with multiple sclerosis (MS) develop cognitive deficits,
which often lead to unemployment and negatively affect patients* quality of
life. In order to prevent (or delay) the development of severe cognitive
impairment, early identification of cognitive decline might be crucial.
Unfortunately, neuropsychological testing is currently not part of standard
care (due to lack of time and trained personnel) and is often only performed
when problems are already too advanced. The recently developed Multiple
Screener©, a self-explanatory digital screening tool, aims to assess cognitive
performance in a time-efficient manner without the need of a test-leader. While
the Multiple Screener© has already been tested in healthy subjects and norm
scores are available, a validation in patients with MS is an essential next
step in allowing timely identification of cognitive decline in this group.
Study objective
The main objective of this study is to determine how well the Multiple
Screener© can differentiate between patients with no cognitive deficits, mild
cognitive deficits and cognitive impairment. Additionally, we aim to confirm
the observed accuracy of the Multiple Screener© in an independent sample of MS
patients and determine test-retest reliably of the Multiple Screener©. Lastly,
we will investigate how cognitive, psychological, work-related and quality of
life outcomes relate to each other.
Study design
A cross-sectional multicenter study
Study burden and risks
All participants will undergo a neuropsychological assessment (120-150 min) at
a hospital close to their home and fill out online questionnaires (45-60 min)
regarding psychological, work-related and quality of life measures.
Additionally, a subset (N= 30) of participants will be reassessed with the
Multiple Screener© within 1-3 weeks after the initial hospital visit for the
test-retest measurement. Undergoing neuropsychological testing and answering
questionnaires on psychological, work-related and quality of life measures may
be confronting for some participants. However, as for most patients these
issues are not unexpectedthe burden of this study is primarily the
time-investment and a minimal risk is expected for participants.
De Boelelaan 1118
Amsterdam 1081 HZ
NL
De Boelelaan 1118
Amsterdam 1081 HZ
NL
Listed location countries
Age
Inclusion criteria
- Confirmed MS diagnosis according to the McDonald 2017 criteria
- Age between 18 and 67
- No recent changes in disease modifying therapy (i.e., no changes in last 3
months)
- No current relapse or steroid treatment in the six weeks prior to the study
visit
Exclusion criteria
- Patients with neurological (other than MS) and psychiatric disorders
- A current or history of drug or alcohol abuse
- Being unable to speak or read Dutch
Design
Recruitment
Medical products/devices used
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 | NL78850.029.21 |