1. Effectiveness: the study is aimed at increased independence of patients and thereby increasing quality of life and well-being of both patients and caregivers involved. 2. Usability: Use of PDA by patients; frequency and methods of use, prognostic…
ID
Source
Brief title
Condition
- Structural brain disorders
- Cognitive and attention disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The first primary outcome is effectiveness of the PDA-intervention, measured
a.o. as the efficiency on target behaviours measured with an interview.
Furthermore, subjective cognitive problems in daily life and social and
instrumental activities will be measured with questionnaires Finally, a measure
of self-efficacy will be used.
The second primary outcome is *usability* of the device used for the
intervention. A semistructured interview will be used to ask the users
(patients and caregivers) about their experiences with the use of the PDA. In
addition, the log file will be evaluated and the percentage of persons still
wanting to use the PDA after 8 and 16 weeks is calculated.
Secondary outcome
Although improvement on neuropsychological test performance is not expected, a
pre and post intervention assessment of basic cognitive abilities will be
performed .A measure for mood, especially depression after brain injury will be
used. Subjective well-being and quality of life are recorded. Finally, some
aspects of functioning of the caregiver involved will be assessed: mood
(depression), caregiver strain and well-being and quality of life.
Background summary
In the Netherlands about 200.000 people live with the consequences of stroke
and traumatic brain injury. The cognitive, emotional and behavioural
consequences of brain injury occur in many people, and lead to severe
disabilities, problems with participation in society and long-term care
dependency. Cognitive rehabilitation (CR) is an effective form of health care
for this group of patients, which enables them to manage, reduce, or live with
the probably persistent cognitive deficits. The objectives of CR are to improve
a person's functions in domains that are relevant to their everyday lives. The
effectiveness can be found in community-reintegration and increased quality of
life, by meeting real life demands and positive changes in productivity and
subjective well-being. 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.
Study objective
1. Effectiveness: the study is aimed at increased independence of patients and
thereby increasing quality of life and well-being of both patients and
caregivers involved.
2. Usability: Use of PDA by patients; frequency and methods of use, prognostic
factors for successful use.
Study design
Single-blind, randomized clinical trial
Intervention
The experimental group will receive the PDA-training 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.
Study burden and risks
This study will have a low burden and has no special risk associated with
participation.
Dr. Tanslaan 12
6229 ET Maastricht
Nederland
Dr. Tanslaan 12
6229 ET Maastricht
Nederland
Listed location countries
Age
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
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 | NL21155.068.08 |