Patients with ABI follow a multidisciplinary rehabilitation program. This program is very intensive and also requires a lot from loved ones. The burden can be reduced by partly delivering the program from home.The aim of this project is to implement…
ID
Source
Brief title
Condition
- Structural brain disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measures are sustained and divided attention and working
memory, which will be measured with objective neuropsychological tests. For
general cognitive screening, the Montreal Cognitive Assessment (MoCA) will be
used.
Changes in visual selective attention, processing speed and concentration are
measured with the D2 test.
Changes in visual attention, executive function (divided attention) and
processing speed are measured with the TMT A & B.
The Stroop Test measures mental speed, executive attention and response
inhibition.
Attention and working memory are examined using the digit span forward (DSF)
and digit span backward (DSB). Together with 'Arithmetics', an index for
working memory can be calculated.
Secondary outcome
Secondary outcome measures are self-management, subjective cognitive
complaints, mood, fatigue and quality of life, which will be measured with
standardized questionnaires.
The feasibility of the blended care pathway will be qualitatively evaluated by
documenting compliance with the protocol (number of completed sessions,
dropouts), the outcomes of focus groups (barriers and facilitators), an
evaluation form (yet to be developed) and a standardized questionnaire, with
which the appreciation of the process of implementation by therapists is
evaluated.
Background summary
Cognitive complaints are the most common and disabling consequences of acquired
brain injury (NAH). At Rijndam Rehabilitation we treat cognitive complaints
with individual therapy sessions, in which metacognitive compensation
strategies are taught, in combination with a computer-controlled cognitive
rehabilitation program (CCR; ReHaCom). This CCR program is comparable to a
computer game; Through a lot of practice an increasingly higher level can be
achieved. This motivates the patient to continue practicing. A wish of patients
is to also be able to train at home. An online version of the ReHaCom program
has recently become available, allowing patients to continue cognitive training
independently or with the help of a loved one at home with remote guidance.
Study objective
Patients with ABI follow a multidisciplinary rehabilitation program. This
program is very intensive and also requires a lot from loved ones. The burden
can be reduced by partly delivering the program from home.
The aim of this project is to implement home-based CCR in combination with
strategy training in the outpatient care pathway of Rijndam Rehabilitation for
patients with NAH and to evaluate both the implementation process and the
effect of the therapy on the patient's functioning.
Study design
The effect evaluation consists of a randomized cross-over study. We measure the
effect of the therapy on cognitive and psychological functioning,
self-management and quality of life using objective neuropsychological
examination and standardized questionnaires.
For the process evaluation, the feasibility and satisfaction of patients and
relatives will be evaluated by means of focus groups and questionnaires and
the experiences of therapists through interviews and questionnaires.
Intervention
The intervention consists of a combination of strategy training and the
evidence-based CCR ReHaCom-Online. The CCR program consists of a selection of
29 modules with various levels, making the therapy challenging and the game
element motivates to continue practicing. The patient's progress can be
monitored remotely, so that the therapist can intervene if necessary. This
feedback allows the therapist to better tailor the individual sessions to the
patient's level. By combining strategy training at the outpatient clinic and
CCR from home, we strive for an optimal form of blended care.
Study burden and risks
In the blended care program, patients are instructed to follow a home-based CCT
program. Training at home requires a time investment from patients, but will
also reduce the number of visits to the rehabilitation center. Participants can
choose what time of day is most convenient for them to participate in the
program in their home environment, rather than traveling to the rehabilitation
center for scheduled cognitive training. Increasing patients' responsibility in
their recovery process can improve their self-efficacy and quality of life.
Completing online questionnaires also requires a certain time investment from
patients and can lead to temporary fatigue. Patients can take a break at any
time and continue completing the questionnaires at a later time. With a maximum
duration of 60 minutes per measurement, we strive to minimize the burden for
patients. There are no risks associated with participation.
Dr. Molewaterplein 40
Rotterdam 3015GD
NL
Dr. Molewaterplein 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
- receiving outpatient rehabilitation for acquired brain injury (ABI)
- age at least 18 years
- no cognitive complaints before ABI
- patient has sufficient knowledge of the Dutch or English language
- internet access
Exclusion criteria
-incapacitated or progressive neurological disease, such as Alzheimer's disease
Design
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| CCMO | NL88519.078.24 |