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Tied by tiredness: blended care intervention for fatigue in brain disorders

Tied by tiredness: blended care intervention for fatigue in brain disorders - Tied by tiredness

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON55248
Enrollment
110
Registered
2021-01-25
Start date
2021-09-28
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

langdurige vermoeidheidsklachten na hersenletsel 'brain damage' en 'acquired brain injury (ABI)'

Interventions

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., loc

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

Exclusion criteria: 1.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)