To test the feasibility and preliminary effectiveness of the MOE! program in young people (12-19 years old) with ABI in four rehabilitation centers (Basalt/Merem/Revant/Heliomare) and update the program where needed based on experiences and outcomes…
ID
Source
Brief title
Condition
- Structural brain disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameter will be: A blended intervention will be delivered to
reduce fatigue. The PedsQL* Multidimensional Fatigue Scale (PedsQL*-MFS) will
be used as main endpoint to study fatigue pre- and post-intervention.
Secondary outcome
Secundary parameters for the pilot intervention will be participation, quality
of life, compliance, goal achievement and physical fitness.
Parameter (measured by)
Participation (Child and Adolescent Scale of Participation (CASP))
Quality of life (PedsQL Generic Core Scales 4.0 (GCS-4.0))
Compliance, training and daily activity levels (Digital monitoring of the
progress with Minddistrict/Physitrack) (and an activity tracker that measures
active minutes per hour, steps taken per hour, heartrate variability per hour,
burneg calories per hour, VO2max per dag and sleeptime per day/night)
Goal achievement (Questionnaires at the end (achieved yes/no and program
satisfaction))
Physical fitness (6 minute walk test and handheld dynamometry)
Goal achievement, feasibility and satisfaction (questionnaires)
Background summary
Around 75% of the children and adolescents with Acquired Brain Injury (ABI)
mention fatigue as one of the most important persistent problems (Norup et al.,
2019; Van Markus-Doornbosch et al., 2019; Wilkinson et al, 2018). Fatigue among
children and young adults undergoing rehabilitation is significantly higher
compared to their healthy peers (Allonsius et al., 2022). Young people mention
that they need good treatment for their fatigue, but do not want to go to a
rehabilitation center for therapy multiple times a week. Ideally, they want a
combination of on-site practice/training (with peers) and digital treatment
support at home (Blended Care). A treatment for adults to reduce fatigue exists
but is not available for young people between the ages of 12 and 19, nor is it
available in a blended care form. Therefore we have adapted the existing
intervention for adults in co-creation with young patients with ABI and
healthcare professionals and created a blended program for the target group.
This blended care fatigue program is called MOE! (Meedoen, Opladen, Energie!).
Study objective
To test the feasibility and preliminary effectiveness of the MOE! program in
young people (12-19 years old) with ABI in four rehabilitation centers
(Basalt/Merem/Revant/Heliomare) and update the program where needed based on
experiences and outcomes.
Study design
This study concerns a prospective intervention study with a pre-post analysis
to investigate feasibility and pre-liminary effectiveness.
Intervention
COGRAT is an existing intervention proven effective in reducing fatigue and
will be adapted and made blended for the target group (MOE!)**.
Study burden and risks
Participation in this study will cost participants time and they have to wear
an activity tracker. However, only patients who would have been treated for
their fatigue anyhow will be included, and the new intervention will replace
usual care. The benefits for the participants will be that fatigue will
possibly be reduced and participation in daily life will improve.
Vrederustlaan 180
Den Haag 2543 SW
NL
Vrederustlaan 180
Den Haag 2543 SW
NL
Listed location countries
Age
Inclusion criteria
- Age 12-19 years,
- Must be diagnosed with ABI (traumatic/non-traumatic).
- Physically/cognitively sufficiently capable (assessment by rehabilitation
physician),
- Sufficient knowledge of the Dutch language (for completing questionnaires and
following online instructions/modules),
- Access to a phone/tablet with internet,
- Able to independently complete digital assignments (cognitive and physical
training),
- Able to come to the rehabilitation center for physical meetings.
Exclusion criteria
Limiting psychiatric disorders
Design
Recruitment
metc-ldd@lumc.nl
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 | NL87680.058.24 |