|- candidate number||3029|
|- NTR Number||NTR1219|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||14-mrt-2008|
|- Secondary IDs||08-3-007 MEC |
|- Public Title||“NeuroCue”, a randomized controlled study into the use of an electronic cognitive aid in patients with acquired brain injury|
|- Scientific Title||“NeuroCue”, a randomized controlled study into the effectiveness and usability of a Personal Digital Assistant (PDA) used by patients with acquired brain injury.
|- hypothesis||The intervention entails the use of a personal digital assistant (PDA) for brain injured persons with attention, initiative, memory or planning deficits aimed at the reduction of everyday problems and less dependency on care facilities. And thereby increasing quality of life and well-being of both patients and caregivers involved. |
|- Healt Condition(s) or Problem(s) studied||Stroke, Efficacy, Quality of life, Acquired brain injury, Traumatic brain injury, Cognitive rehabilitation, Personal digital assistant (PDA), Independence|
|- Inclusion criteria||1. Patients with acquired brain injury in either a subacute or a chronic phase |
2. Patients are referred for cognitive rehabilitation
3. Age between 18 and 75 years
4. Adequate comprehension of the Dutch language.
5. Experienced problems in daily life functioning as a consequence of brain damage; insight into cognitive deficits; sufficient IQ level to benefit from treatment -- all according to the rehabilitation physician or psychologist.
|- Exclusion criteria||1. Visual difficulties incompatible with PDA use |
2. Serious psychiatric comorbidity
3. Progressive disorders, such as Alzheimer’s, Parkinson’s disease and other forms of dementia
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2008|
|- planned closingdate||1-jan-2010|
|- Target number of participants||128|
|- Interventions||During the baseline period (2 weeks) target behaviours are determined for all participants. The experimental group will receive the PDA for a period of 16 weeks, the control group will receive ‘care-as-usual’, defined as calendar training or other types of strategy training to cope with their cognitive disabilities. Both groups will receive an equal amount of therapy time, namely 15-20 hours in total. |
|- Primary outcome||Effectiveness of the PDA-intervention: The first primary outcome is the efficiency on target behaviours measured with an interview. Furthermore, subjective cognitive problems in daily life, self-efficacy and social and instrumental activities will be measured.|
Usability of the PDA-intervention: The second primary outcome are the experiences of patients and caregivers with the use of the PDA. The effective use of the device will also be evaluated.
|- Secondary outcome||• levels of distress and depression for the user |
• levels of distress, strain and depression for the caregivers
• quality of life for patients and close family members
|- Timepoints||There will be 5 measurements during the intervention for each patient. |
A double baseline (two and zero weeks before the intervention), and measurements at 8 and 16 weeks after the start of the intervention.
A follow-up measurement is performed 3 months after the intervention has ended.
|- Trial web site||http://www.np.unimaas.nl/neurocue|
|- CONTACT FOR PUBLIC QUERIES||Msc. E.A. Joode, de|
|- CONTACT for SCIENTIFIC QUERIES||Msc. E.A. Joode, de|
|- Sponsor/Initiator ||University Maastricht (UM)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||In this research project a new form of CR offered in the community is evaluated, establishing the clinical and societal effectiveness. The intervention entails the use of a personal digital assistant (PDA) for brain injured persons with attention, initiative, memory or planning deficits aimed at the reduction of everyday problems and less dependency on care facilities. The PDA will serve as a reminder or planning system to compensate for reduced cognitive functions. Large scale controlled outcome studies of these systems do not exist. In the proposed study usability and effectiveness will be investigated.|
|- Main changes (audit trail)|
|- RECORD||24-jan-2008 - 3-apr-2008|