Clinical trial NCT04067193: E-vone® Use Detect Falls Among hOspitalized Patients in geRiAtric Medicine
Official title: Usability Study of PARADE CONNECT Shoes, a Device to Detect Falls in Old People
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients Hospitalised in Geriatrics
Keywords: old people
fall
elderly
fall detection
usability
satisfaction
ergonomy
shoes
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2019-08-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are recruited during their hospitalisation in geriatric medicine. Relatives / unformal caregivers are recruited during the hospitalisation of patients in geriatric medicine. Professionnal caregivers are recruited in the acute care geriatric unit.

Brief summary: This study evaluates the usability of a new remote warning system for fall in old people. This system is integrated in a shoe. Patients hospitalized in a geriatric ward but also their informal and professional caregivers will assess the usability of the device using a structured survey.

Detailed description: Falls are a major health concerned because of their frequency and severity. It is estimated that 30% of people over 65 years old and 50% of those over 85 years old fall at least once a year. Falls are also one of the main factors of morbidity, mortality and early institutionalization for old people.

Preventive measures have been implemented to limit the recurrence of falls. Most of these preventive measures are secondary and tertiary prevention programs, such as MultiFactorial Interventions (MFIs). Home-based programs are under evaluation, but evidences of their effectiveness are currently controversial. Effects of prevention programs for in and outpatients remain modest. The objectives of these interventions are to decrease the frequency of falls but also to decrease the severity of falls.

The severity of falls is due to their physical complications (found in 50 to 55% of cases), their psychological complications (40%) but it is also reflected by the subsequent hospitalizations (20%), the acceleration of dependency (50%) and the institutionalizations (40%). Falls are complicated by death in 5% of cases.

In addition, the literature on fall complications is profuse. One of these complications is the hip fracture. Hip fracture is the main cause of mortality and loss of autonomy due to falls. However, in a previous study conducted by Bloch et al. in 2009 at Cochin Hospital, several indirect evidences tended to show that mortality from falls was related to the metabolic disorders linked to the extended stay on the ground, rather than to immediate traumatic consequences. As metabolic disorders reflects the time needed to be rescued, this article highlights the importance of using early warning systems to reduce the occurrence of such complications in old frail patients living alone, and unable to get up alone from the ground.

The most commonly used warning tools are remote assistance systems (necklace or bracelet) with a button to push in case of a fall. In the study conducted by Flemming et al. in 2008, when these systems are activated, the great majority of fallers are back on their feet within one hour after the alert. Nevertheless, of 143 old people living alone and unable to get up alone from the ground, only 28 were using a warning system. The reasons for non-use are as follows: the person does not have a warning remote assistance systems, the person owns a warning remote assistance systems but was not wearing it at the time of the fall, the person was wearing a warning remote assistance systems but was forgetting (or was in difficulty) to use it.

Many research projects on fall warning and detection systems have been initiated. In the 2018 meta-analysis by Nguyen et al., fall detection systems are divided into 2 groups: a pre and a post-fall group. In the latter group, the detection systems were mainly using 3D accelerators, gyroscopes, magnetometers or smartphones with the above-mentioned devices. However, to date, there is no reliable detection system on the market because some obstacles remain. These obstacles are concerning technology but also usability. Concerning technological issue, one of the problems remains the ability of devices to detect low kinetic falls, which is common in the elderly. Concerning usability, questions are for example the problem of the voluntary activation by the user of the most common devices, or the absence of wearing the device during numerous falls.

PARADE CONNECT would remove some of the usability obstacle typically associated with remote warning systems. Indeed, the system is activated independently of the will, cognitive state and consciousness of its user. The warning system is integrated into a shoe usually worn by the old people, with probably a less stigmatizing character of aging and loss of independence. This is why it seems important to us, as a first step, to evaluate its acceptability and usability by patients.

Eligibility criteria: Inclusion criteria:

* Patients :

  * Aged 65 years old and over
  * To be hospitalised in geriatric medicine department of Angers University Hospital
* Unformal caregivers :

  * Family members or relatives
  * Age 18 years and over
* Professional caregivers:

  * geriatric medicine department's staff of Angers University Hospital
  * aged of 18 years and over

Exclusion criteria:

* Patients :

  * To have motor disability or walking contraindications
  * To be under legal protection
* Refusal of participating

Primary outcomes:
measure: Usability of the PARADE CONNECT shoes: Average of the usability scores
timeFrame: within 24 hours after removal of the device
Secondary outcomes:
measure: Satisfaction of the PARADE CONNECT shoes: recommendation scale
timeFrame: within 24 hours after removal of the device
measure: Ergonomic of the PARADE CONNECT shoes
timeFrame: within 24 hours after removal of the device
measure: Preferred shape for the PARADE CONNECT shoes
timeFrame: within 24 hours after removal of the device
measure: Acceptability of the PARADE CONNECT shoes: Average acceptability score
timeFrame: within 24 hours after removal of the device
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital
Study officials:
affiliation: Angers University Hospital
name: Cédric Annweiler, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: