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

Completed

Conditions: langdurige vermoeidheidsklachten na hersenletsel
'brain damage' en 'acquired brain injury (ABI)'
10007963

Registration Number: NL-OMON55248

Lead Sponsor: niversiteit Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 110

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the severity of self-reported fatigue symptoms<br /><br>post-treatment (T1), at 3-months follow-up (T2) and 6-months follow-up (T3).<br /><br>Primary outcome measure for the cost effectiveness will be the five-dimensional<br /><br>five-level EuroQol (EQ-5D-5L) and acost-questionnaire specifically designed for<br /><br>this study.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures are the Utrecht Scale for Evaluation of<br /><br>Rehabilitation-Participation-restrictions scale (User-P), CheckList Cognition<br /><br>and Emotion (CLCE-24), Hospital Anxiety and Depression Scale (HADS), Attainment<br /><br>of personal goals with the help of visual analoge scale, Dutch Multifactor<br /><br>Fatigue Scale (DMFS), ESM-questions and the SF-12.</p><br>