Haalbaarheidsonderzoek: introductie wearables bij heupfractuurpatienten 75+

Background of the study: 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. Objective of the study: 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%). Study design: 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. Study population: - 75 years and older - hip fracture Primary study parameters/outcome of the study: There are 3 end points: 1) The percentage of the entire population of hip fracture patients (75+) enrolled 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%).

It is feasibility to introduce sleep and activity wearables in hip fracture patients (75+) during hospitalization

4 months trial

Registration of sleep monitoring and activity data of the patient by means of a data tracking wrist bracelet