The primary objective is to explore whether sleep monitoring data correlate with DOS score in patients admitted for hip fracture.
ID
Source
Brief title
Condition
- Bone and joint injuries
- Deliria (incl confusion)
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main endpoint: Relationship between sleep tracking parameters and DOS score
Main parameters:
* Gender
* Use of cardiac medication
* Alcohol use prior to fall
* DOS score
* Duration and total percentage of sleep stages: 1) sleep; 2) awake; 3) deep;
4) REM
* Time to fall asleep
* Duration and total percentage of restlessness
* Heartbeat
* Number of movements
Secondary outcome
Not applicable.
Background summary
Delirium occurs in 25% to 61.3% of geriatric hip fracture patients, depending
on the measurements methods and criteria used (Brännström et al., 1989; Milisen
et al., 2001; Williams et al., 1985) and is associated with two to five times
higher mortality risk (Tess, 1991). Early recognition of delirium and treatment
of older hip fracture patients has been shown to affect its severity and its
duration (Milisen et al., 2001) and may contribute to a positive clinical
outcome (Cole et al., 1994; Williams et al., 1979). A possible link between
delirium and sleep disturbances has been hypothesized in terms of a common
pathophysiologic pathway, shared mechanisms, and a potential cause-effect
relationship (Figueroa-Ramos et al., 2009). In addition sleep tracking with
wearables has been introduced and gone through verification and validation,
however within a healthy population (de Zambotti et al., 2016, 2018; Washington
et al., 2016). This research hypothesizes the ability of wearable sleep
tracking to improve hospital care among elderly hip fracture patients.
Moreover, sleep disturbances for whatever cause may point into the direction of
delirium caused by numerous possible stressors. This study aims to detect
differences of sleeppatterns which correlate with clinical outcome measures,
i.e. DOS (Delirium Observation Screening) scoring (Scheffer et al., 2011*
Schuurmans et al., 2003) of delirium in hip fracture patients (80+).
Study objective
The primary objective is to explore whether sleep monitoring data correlate
with DOS score in patients admitted for hip fracture.
Study design
This study is an exploratory prospective trial, aiming to explore the
relationship between sleep monitoring data and DOS score. The sleep monitoring
data and delirium score of the eligible patients will be registered during
their hospital stay. The sleep data will be collected by means of a wearable
bracelet and the delirium status will be scored with the DOS score. The DOS
will be applied three times a day, at each shift, by qualified nurses.
Potential relationship between sleep monitoring parameters and DOS scores will
be assessed by applying correlation and regression methods (linear mixed
models) on the collected data.
Study burden and risks
The patient will be supplied with a tracking device at the wrist. A so-called
Fitbit Charge 3 tracker with a display of a clock. The tracking devices will be
disinfected before use. There is no risk of harm by wearing this measurement
device.
Reinier de Graafweg 5
Delft 2625AD
NL
Reinier de Graafweg 5
Delft 2625AD
NL
Listed location countries
Age
Inclusion criteria
* A hip fracture
* 80 years and older
* Admitted to the hospital
* Mentally competent
* Informed consent obtained
Exclusion criteria
* Mentally incompetence
* Nickel allergy
Design
Recruitment
metc-ldd@lumc.nl
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 | NL70878.098.19 |