Examining the clinical and cost-effectiveness of Moe-i-teloos, compared with treatment as usual (TAU), for individuals with stroke or TBI who report fatigue symptoms.
ID
Source
Brief title
Condition
- Other condition
- Central nervous system vascular disorders
Synonym
Health condition
langdurige vermoeidheidsklachten na hersenletsel
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the severity of self-reported fatigue symptoms
post-treatment (T1), at 3-months follow-up (T2) and 6-months follow-up (T3).
Primary outcome measure for the cost effectiveness will be the five-dimensional
five-level EuroQol (EQ-5D-5L) and acost-questionnaire specifically designed for
this study.
Secondary outcome
Secondary outcome measures are the Utrecht Scale for Evaluation of
Rehabilitation-Participation-restrictions scale (User-P), CheckList Cognition
and Emotion (CLCE-24), Hospital Anxiety and Depression Scale (HADS), Attainment
of personal goals with the help of visual analoge scale, Dutch Multifactor
Fatigue Scale (DMFS), ESM-questions and the SF-12.
Background summary
Fatigue ranks among the most prevalent consequences of brain injury and has
been associated with lower quality of life, poorer neurological recovery and a
higher risk of mortality. However, effective interventions for fatigue after
brain injury are lagging behind. In this project, we will run a trial of a
novel intervention for fatigue after mild to moderate brain injury (*Moe-
i-teloos*). Moe-i-teloos is a blended care intervention, consisting of a
mHealth web application where participants monitor their daily lives, combined
with personalized face-to-face of screen-to-screen feedback by a treating
health professional.
Study objective
Examining the clinical and cost-effectiveness of Moe-i-teloos, compared with
treatment as usual (TAU), for individuals with stroke or TBI who report fatigue
symptoms.
Study design
Multicenter two-group parallel single-blind Randomized Controlled Trial (RCT)
with baseline (T0), post-treatment (T1), 3-months follow-up (T2) and 6-months
follow-up (T3).
Intervention
6 week treatment program aimed at reducing fatigue symptoms after acquired
brain injury. During the intervention, participants monitor their symptoms,
behaviour and contextual information (e.g., location) in the flow of daily life
using a well-validated app developed at the UM, which will be installed on
their smartphone. At the end of each week, a face-to-face or screen-to-screen
feedback session with a therapist is planned. The central aim is to provide
personalized insight in everyday functioning, fatigue and related factors, and
to put into action behavioral/contextual changes to improve fatigue, other
symptoms, and participation.
Study burden and risks
The study is a therapeutic study without risks for the participants.
Participant burden consists of filling in questionnaires for a maximum of 4
times over a period of 9 months. Participants in the intervention group will
also be asked to monitor their symptoms, mood, behaviour and contextual
information during the intervention phase of the study (6 weeks) during 3 days
each week. This will result in approximately 20 minutes per day * 3 days per
week * 6 weeks = 360 minutes (or 6 hours, or 1 hour per week). This may be
experienced as a burden or may make participants more aware of the presence of
negative feelings (e.g., depressed mood). This study provides participants with
a highly detailed insight in their own symptom patterns and behaviors, which
constitute the basis for interventions aimed at reducing fatigue, and improving
mood, participation and well-being (i.e., the goal of the Moe-i-teloos
intervention). The number of visits to the clinic does not differ from regular
treatment (control group).
Universiteitssingel 40
Maastricht 6229ER
NL
Universiteitssingel 40
Maastricht 6229ER
NL
Listed location countries
Age
Inclusion criteria
1. Stroke or TBI;
2. Objectified by a physician/neurologist (i.e., presence of brain damage;
period of loss of consciousness at time of injury) and/or neuropsychologist
(i.e., impaired neuropsychological test results following the brain injury).
3. Starting outpatient rehabilitation;
4. Referred for treatment of fatigue and scoring 4 or higher on Fatigue
Severity Scale;
5. Good comprehension of Dutch (PsyMate);
6. Capable of handling smartphone
7. Willing and able to give informed consent
Exclusion criteria
1. <18 years;
2. Current diagnosis of depression or chronic fatigue syndrome;
3. Currently receiving cancer treatment
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 | NL74449.068.20 |