This study aims to: 1. Determine the role of early neurocognitive functioning in the outcome from ABI in rehabilitation, as defined by the level of neurocognitive functioning, participation and quality of life at six months after start of the…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study paramenters are:
1. Neurocognitive functioning
2. Coping
3. Participation
4. Quality of life
Secondary outcome
Not applicable.
Background summary
Acquired Brain Injury (ABI) can severely impact every-day functioning through
physical, neurocognitive, emotional and behavioural disturbances, thereby
affecting participation and the quality of life of these patients on the long
term. ABI rehabilitation programmes help to improve function and decrease
disability in patients, but there are great differences in long-term outcome
between patients. The underlying causes of these differences remain largely
unclear, although neurocognitive functioning and coping are considered
important factors influencing ABI outcome after rehabilitation. The current
study aims to explore the roles of neurocognitive functioning and coping in
participation and quality of life during rehabilitation after ABI. This study
will contribute to our knowledge of factors influencing outcome of ABI, thereby
exposing targets to improve rehabilitation programmes.
Study objective
This study aims to:
1. Determine the role of early neurocognitive functioning in the outcome from
ABI in rehabilitation, as defined by the level of neurocognitive functioning,
participation and quality of life at six months after start of the
rehabilitation trajectory.
2. Determine the modulating role of coping in the relation between
neurocognitive functioning and outcome of rehabilitation after ABI, as defined
by participation and quality of life at six months after start of
rehabilitation trajectory.
Study design
A longitudinal observational study design.
Study burden and risks
There will be two assessments for participating subjects. The first assessment
(T1) will be during the first two weeks of the rehabilitation programme and the
second assessment (T2) will be six months later. The assessments both comprise
administration of a neurocognitive test battery (75 minutes) and completion of
three self-report questionnaires. At assessment T1 participants will also be
asked to fill out a demographics and medical history questionnaire. Duration of
assessment T1 is estimated at 115 minutes (maximum duration: 130 minutes) and
duration of assessment T2 is estimated at 105 minutes (maximum duration 120
minutes), summing up to a total estimated assessment time of 220 minutes
(maximum: 250 minutes) over a period of 6 months. Risk of participation is
considered negligible.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
The subject is at least 18 years old.
The subject has acquired brain injury, which is acquired less than three months
ago.
The subject has given verbal and written consent.
Exclusion criteria
The subject is unable to comprehend task instructions or fill in the
questionnaires, due to a language barrier or a severe form of aphasia.
The subject is unable to complete the neuropsychological assessment, due to
disturbances in consciousness, severe fatigue, severe motor disability that
interferes with outcome assessment at time of assessment or inability to
comprehend testing instruction at time of assessment other than aphasia.
The subject is diagnosed with a degenerative disorder, like Parkinson's disease
or Multiple Sclerosis.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL76395.018.21 |
| OMON | NL-OMON29123 |