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Patients Hospitalised in GeriatricsEDORANCT04067193

E-vone® Use Detect Falls Among hOspitalized Patients in geRiAtric Medicine

An observational study of Patients Hospitalised in Geriatrics, run by University Hospital, Angers at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Patients Hospitalised in Geriatrics
What is being tested?
usability survey
How many people
60 participants
Where
1 siteFrance
Study dates
30 Oct 2019to 3 May 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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
Show all 9Show fewer
  • Professional caregivers:
  • geriatric medicine department's staff of Angers University Hospital
  • aged of 18 years and over

Who cannot join

  • Patients :
  • To have motor disability or walking contraindications
  • To be under legal protection
  • Refusal of participating

Trial locations and contacts

1 site in 1 country.

Cédric ANNWEILER, MD, PhD contact

0241354725 ext. +33

allegro@chu-angers.fr

France1 site
  • Angers University Hospital

    Angers, 49933 cedex 9

Other trials in France

About this study

Official title: Usability Study of PARADE CONNECT Shoes, a Device to Detect Falls in Old People

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.

Read the 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.

Being tested
usability survey
Keywords
old people, fall, elderly, fall detection, usability, satisfaction, ergonomy, shoes
Medical subject headings
Personal Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • usability surveyOther

    usability survey composed of subpart: System Usability Scale, questions about ergonomic, questions about design, question about global satisfaction.

Study groups in NCT04067193
Study groupRoleWhat they receive
old geriatric inpatientsusability assessment after 24 to 72 hours of possible use of the device (PARADE CONNECT shoes)
Receives: Other: usability survey
unformal caregiversusability assessment after 24 to 72 hours of possible use of the device (PARADE CONNECT shoes) by their relative
Receives: Other: usability survey
professional caregiversusability assessment after the possible use of the device (PARADE CONNECT shoes) by 40 hospitalzed old patients in the geriatrics ward
Receives: Other: usability survey

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Usability of the PARADE CONNECT shoes: Average of the usability scores

    Average of the usability scores. Usability score is calculated using the responses to the validated System Usability Scale (SUS). An average score equal or over 70/100 will be considered as satisfying.

    Measured: within 24 hours after removal of the device

Secondary outcomes (4)
  1. Satisfaction of the PARADE CONNECT shoes: recommendation scale

    Average recommendation score. Satisfaction score is calculated using the responses to the recommendation scale. This scale is a ten point's scale from 0 (I don't recommend at all) to 10 (I fully recommend). An average score greater than 5/10 would be acceptable, a score greater than or equal to 7/10 would be satisfactory.

    Measured: within 24 hours after removal of the device

  2. Ergonomic of the PARADE CONNECT shoes

    Average ergonomics score: The ergonomics score is a composite score based on the average of the answers to five ergonomics questions on a four-level Likert scale. The Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). The average score is reported on ten. An average score greater than 5/10 would be acceptable, a score greater than or equal to 7/10 would be satisfactory.

    Measured: within 24 hours after removal of the device

  3. Preferred shape for the PARADE CONNECT shoes

    Three shape of shoes will be presented. Each participant will be asked about his preferred shape of shoes. The prefered shape will be the most choose shapenof shoes.

    Measured: within 24 hours after removal of the device

  4. Acceptability of the PARADE CONNECT shoes: Average acceptability score

    Average acceptability score: The acceptability score is assessed using a closed question. The response is based on a four-level Likert scale. The Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). The average score is reported on ten. An average score greater than 5/10 would be acceptable, a score greater than or equal to 7/10 would be satisfactory.

    Measured: within 24 hours after removal of the device

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2019
  2. Study start30 Oct 2019 (estimated)
  3. Primary completion30 Apr 2021 (estimated)
  4. Study completion3 May 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04067193
Sponsor's protocol ID
2019/49
Acronym
EDORA
Status last verified
Sep 2019
First submitted
21 Aug 2019
Last updated
4 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Patients Hospitalised in Geriatrics, run by University Hospital, Angers at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Cédric ANNWEILER, MD, PhD (0241354725 ext. +33, allegro@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Usability of the PARADE CONNECT shoes: Average of the usability scores (time frame: within 24 hours after removal of the device). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2019.

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