To investigate whether the Actiwatch® actigraph and the Everon* sensor can be helpful in the early diagnosis of a delirium. If both are able to do so, we evaluate which of the two performs best as a delirium screening device.
ID
Source
Brief title
Condition
- Deliria (incl confusion)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints are the activity patterns and circadian rhythms as measured
by the wrist-actigraph and the Everon sensor.
Secondary endpoints are: diagnosis, onset, duration and severity of the
delirium, determination of delirium subtype, tolerability of the 2 devices by
the patients, and statistics of the activity patterns of the delirious patients
and the non-delirious patients.
Secondary outcome
Secondary endpoints are: diagnosis, onset, duration and severity of the
delirium, determination of delirium subtype, tolerability of the 2 devices by
the patients, and statistics of the activity patterns of the delirious patients
and the non-delirious patients.
Background summary
Elderly patients admitted to the hospital frequently suffer from a delirium. A
delirium is a syndrome that is characterized by symptoms of disturbed
consciousness, concentration and cognition, and symptoms of disturbed sleeping
patterns. In addition, a delirium is highly heterogeneous in clinical
presentation. This is represented in the concept of hypoactive, hyperactive and
mixed motor subtypes, which states that patients can be classified according to
their activity pattern. It is important to distinguish between the subtypes
since each of them requires a specific treatment. Subtyping is based on
observations and scales without any available golden standard. The diagnosis
delirium is therefore frequently missed, especially the hypoactive and mixed
subtypes. Preliminary studies have shown that devices capable of measuring
patients* activity can play a role in the early screening of delirium. We want
to investigate whether two specific devices are able to do so, and which of the
two devices performs best.
Study objective
To investigate whether the Actiwatch® actigraph and the Everon* sensor can be
helpful in the early diagnosis of a delirium. If both are able to do so, we
evaluate which of the two performs best as a delirium screening device.
Study design
An observational cohort study.
Study burden and risks
Patients* activity patterns will be measured throughout the length of their
hospital stay. The Everon* device is a non-contact sensor that has to be placed
under the patient*s matress, and hence the patient does not notice its
presence. The actigraph is a simple device, the size of a watch, that is placed
on the wrist like a watch. Since most people are used to wearing a watch, we do
not think that patients perceive the actigraph in any way as uncomfortable.
Obviously, there are no risks associated with these devices.
Postbus 22700
1105 DE Amsterdam
NL
Postbus 22700
1105 DE Amsterdam
NL
Listed location countries
Age
Inclusion criteria
* Patients acutely admitted for unplanned surgical repair of hip fracture
* Admitted on the surgical or orthopedic ward
* Age 65 years or older
* Patients or their primary caregivers must be able to give informed consent
Exclusion criteria
* Patients that can*t speak or understand Dutch / English.
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 | NL31530.018.10 |