The purpose of this research is to determine the usability of a wearable regarding the care of people with dementia showing challenging behaviour in a nursing home (geriatric psychiatry department). The relationship between biomedical data and…
ID
Source
Brief title
Condition
- Other condition
- Dementia and amnestic conditions
Synonym
Health condition
neuropsychiatrische symptomen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Relationship between challenging behaviour (frequency, type, duration,
intensity) and biomedical parameters as measured by the wearable (temperature,
movement, heart rate variability, blood volume pulse and skin conductance.
Secondary outcome
* Determine the reaction of people with dementia regarding the putting on and
wearing of the wearable. Do they show discomfort?
When putting on and wearing the wearable it is registered if and how the
subjects react to the wearable (both verbally as nonverbally). In addition,
skin rash/irritations are registered.
* The identification of environmental factors preceding challenging behaviour
and/or increase in stress-related parameters as measured by the wearable.
In case of challenging behaviour and/or increase in stress-related parameters,
the environmental factors (e.g. envorinmental temperature, sounds,
enterling/leaving of persons, events) 15 minutes prior to the challenging
behavior and/or increase of stress-related parameters will be scored.
Background summary
In nursing homes, dementia is often (up to 80%) accompanied by challenging
behaviour, such as anxiety, agitation, apathy, delusions, aberrant motor
behaviour, nighttime behaviour disturbances and disinhibition. Stress plays an
important role in the cause of challenging behaviour. This negatively
influences the quality of life of the specific resident and his environment.
The cause of challenging behaviour can be treated psychosocially, by means of a
thorough analysis of behaviour and context. However, behavioural analysis is
very complex, among other things caused by the client*s limited communicative
capabilities. They cannot indicate themselves what they experience as being
stressful. This hampers the identification of the stressors which cause
challenging behaviour. By measuring biomedical variables, such as movement,
temperature, heart rate variability, blood volume pulse and skin conductance,
by means of a wearable (wristband), stress-related parameters can be measured
easily and continuously.
Study objective
The purpose of this research is to determine the usability of a wearable
regarding the care of people with dementia showing challenging behaviour in a
nursing home (geriatric psychiatry department). The relationship between
biomedical data and behavioural observations will be investigated.
Study design
Multiple case-study, observational research (cross sectional / diagnostic)
Study burden and risks
Burden/risk: Current literature shows that wearables can cause skin rash.
Because the subjects will be wearing the wearable for a relative short amount
of time (3x 4 hours), the risk of skin rash is estimated as low. In case of
skin rash, the subject will be removed from the study and (if necessary) the
skin rash will be seen and treated by the nursing home*s doctor. It is possible
that the subjects find the moment of putting on the wearable uncomfortable. In
case of the expression of objection (as described a priori by the legal
representative and/or described in the code of conduct *The expression of
objection by incapacitated (psycho)geriatric patients in the context of the
WMO*) related to wearing or putting on the wearable, the subject*s study
participation will be terminated.
Benefit: The subject*s gain is potentially high. Challenging behavior can, by
facilitating a psychosocial approach (instead of a pharmacological approach,
often accompanied with many side effects and often insufficiently effective),
be prevented/reduced.
Ds. Th. Fliednerstraat 2
Eindhoven 5631 BN
NL
Ds. Th. Fliednerstraat 2
Eindhoven 5631 BN
NL
Listed location countries
Age
Inclusion criteria
- diagnosed with dementia (NCS)
- living in a nursing home
- show challenging behaviour (as indicated by medical staff): delusions, hallucinations, agitation/aggession, depression/dysophoria, apathy, disinhibition, irritable/lability, aberrant motor behavior and/or appetite and eating abnormalities
Exclusion criteria
- Circumstances which cause an unrepresentative situation (e.g. in case of an infection)
- known allergies to any of the materials used in the medical device, which may come in contact with the skin while wearing.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL67835.015.19 |
| Other | NL7604 |
| OMON | NL-OMON19930 |