Feasibility study: Introduction of sleep and activity wearables in hip fracture patients (75+) applied during hospitalization

The use of wearable technology aimed at health and sport is constantly
increasing. Such equipment is referred to as "wearable" or "activity tracker".
However, the medical application of such equipment is still in its infancy. All
kinds of physiological parameters can be measured with it, such as the number
of steps, the distance, physical activity, energy metabolism and sleep. The
validation of movement activity recorded using this type of equipment has
already taken place (1). One of the manufacturers, Fitbit, produces the Charge®
wearable. The Charge® was validated in measuring sleep components and
correlations with the gold standard, polysomnography (PSG), were found to be
good (1-5). This study was done in healthy individuals. The survey among the
elderly has also taken place (6). Two exploratory studies have also been
conducted on critically ill patients during admission to intensive care (7,8).
The results are encouraging but only the beginning of a new path in clinical
research.
Our main aim is to establish the feasibility of using wearables in the
hospital. We focus on the hip fracture patient, who is usually nursed at the
hospital's Geriatric Trauma Unit (GTU). Feasibility is split into three main
focus areas. First, whether this approach leads to a high enough percentage (>
70%) of participating patients from the entire population of hip fracture
patients (75+). Secondly, whether the use of wearables is acceptable or is
experienced as non-disturbing by patients, and thirdly, whether the signal that
the wearable registers is not lost in the complex logistics of staying in a
nursing ward of the hospital.
The intended patient group is extremely heterogeneous and often particularly
vulnerable. The request for permission to grant scientific research immediately
upon entering the emergency room is not a feasible option. Deliberate granting
of permission to participate is only possible after the operation has taken
place, the pain is under control and the first phase of mobilization has taken
place. The request for subsequent authorization to participate in medical
scientific research is a researched ethical dilemma that has been extensively
discussed by Jansen et al (15). This research group drew up a new concept that
can be presented to an METC per intervention. It concerns "deferred consent".
It is hereby stated that any scientific influence with a very low impact on
welfare can and may without prior permission. In that case, one must still ask
for permission from the letter of GCP. If a patient is unable or unwilling to
participate, participation in the study should be stopped immediately.
In the present situation, the patient wears a wearable on the wrist without
permission. The registered data may be kept, but in the absence of permission
afterwards, the data must be stored, but may not be used. If a patient
subsequently gives permission to participate but withdraws this permission
during the study, the data obtained must be stored and this data can be used
for the study. A patient reserves the right to withdraw from the study at any
time. Even if members of the medical and nursing team find it irresponsible,
the investigation will be stopped immediately.

Feasibility study on the use of wearables during the entire hospital stay (with
a maximum of 7 days) among elderly (75+) hip fracture patients. Feasibility is
defined by three components:
1) Macro feasibility - the percentage of the entire population of hip fracture
patients (75+) included in the study (> 70%);
2) Patient satisfaction with the wearable (>= 70%);
3) Successful logistics process that is tested by storing the wearable data per
included patient (> 80%).

A prospective exploratory study in which patients with a hip fracture who are
admitted to our hospital (Reinier de Graaf Gasthuis) are successively included.
The term of inclusion is a maximum of 1 year, but ends when 68 patients giving
permission to participate. Patients with a hip fracture are admitted to the
RDGG via the SEH. Every hip fracture patient (75+) is given a tracker on the
wrist. At most 8 patients simultaneously receive a wearable upon admission. The
medical and nursing team determines at any time, in accordance with insight and
experience, whether the patient is able to wear the tracker. When in doubt, the
tracker is not put on or taken off immediately and the patient does not
continue to participate in this research activity. This counts as an exclusion
criterion. A second exclusion criterion is that the patient is nursed in a
department other than the GTU.

The patient receives a wearable (Fitbit Charge® 3) on his/her wrist. No adverse
event is expected. Participants will also not benefit from it directly.