**NeuroCue, a randomized controlled study into the use of an electronic cognitive aid in patients with acquired brain injury

Recruiting

Conditions: cognitive disorders after brain injury/problems with memory and planning after brain damage
10042258
10009841

Registration Number: NL-OMON33708

Lead Sponsor: niversiteit Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 140

Inclusion Criteria

• Patients with acquired brain injury in either a subacute or a chronic phase
• Patients are referred for cognitive rehabilitation
• Age between 18 and 75 years
• Adequate comprehension of the Dutch language.
- Adequate level of competence
• Problems in daily life functioning as a consequence of brain damage, some degree of insight into their cognitive deficits and an estimated IQ high enough to benefit from this treatment according to the rehabilitation physician or psychologist.

Exclusion Criteria

- Visual difficulties incompatible with PDA use
- Serious psychiatric comorbidity
- Progressive disorders, such as Alzheimer*s, Parkinson*s disease and other forms of dementia

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The first primary outcome is effectiveness of the PDA-intervention, measured<br /><br>a.o. as the efficiency on target behaviours measured with an interview.<br /><br>Furthermore, subjective cognitive problems in daily life and social and<br /><br>instrumental activities will be measured with questionnaires Finally, a measure<br /><br>of self-efficacy will be used.<br /><br>The second primary outcome is usability of the device used for the<br /><br>intervention. A semistructured interview will be used to ask the users<br /><br>(patients and caregivers) about their experiences with the use of the PDA. In<br /><br>addition, the log file will be evaluated and the percentage of persons still<br /><br>wanting to use the PDA after 8 and 16 weeks is calculated.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Although improvement on neuropsychological test performance is not expected, a<br /><br>pre and post intervention assessment of basic cognitive abilities will be<br /><br>performed .A measure for mood, especially depression after brain injury will be<br /><br>used. Subjective well-being and quality of life are recorded. Finally, some<br /><br>aspects of functioning of the caregiver involved will be assessed: mood<br /><br>(depression), caregiver strain and well-being and quality of life.</p><br>