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.
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.
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.
- Conditions
- Patients Hospitalised in Geriatrics
- 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 group | Role | What they receive |
|---|---|---|
| old geriatric inpatients | usability assessment after 24 to 72 hours of possible use of the device (PARADE CONNECT shoes) Receives: Other: usability survey | |
| unformal caregivers | usability assessment after 24 to 72 hours of possible use of the device (PARADE CONNECT shoes) by their relative Receives: Other: usability survey | |
| professional caregivers | usability 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.
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)
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
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
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
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.
- First posted26 Aug 2019
- Study start30 Oct 2019 (estimated)
- Primary completion30 Apr 2021 (estimated)
- Study completion3 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Hospitalised in GeriatricsStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Cédric Annweiler, MD, PhD, Principal investigator, University Hospital, Angers
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability Study of PARADE CONNECT Shoes, a Device to Detect Falls in Old People
- ClinicalTrials.gov ID
- NCT04067193
- Acronym / sponsor ID
- EDORA / 2019/49
- Conditions
- Patients Hospitalised in Geriatrics
- Keywords
- old people, fall, elderly, fall detection, usability, satisfaction, ergonomy, shoes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 30 Oct 2019 (estimated)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 3 May 2021 (estimated)
- First posted
- 26 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| old geriatric inpatients | – | Other: usability surveyusability assessment after 24 to 72 hours of possible use of the device (PARADE CONNECT shoes) |
| unformal caregivers | – | Other: usability surveyusability assessment after 24 to 72 hours of possible use of the device (PARADE CONNECT shoes) by their relative |
| professional caregivers | – | Other: usability surveyusability assessment after the possible use of the device (PARADE CONNECT shoes) by 40 hospitalzed old patients in the geriatrics ward |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (9 listed)
- Patients :
- Unformal caregivers :
- Professional caregivers:
Key exclusion criteria (4 listed)
- Patients :
- Refusal of participating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| usability surveyusability survey composed of subpart: System Usability Scale, questions about ergonomic, questions about design, question about global satisfaction. | Other | old geriatric inpatients, professional caregivers, unformal caregivers |
Primary outcome
Usability of the PARADE CONNECT shoes: Average of the usability scores
Time frame: within 24 hours after removal of the device
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.
4 secondary outcomes
Satisfaction of the PARADE CONNECT shoes: recommendation scale
Time frame: within 24 hours after removal of the device
Ergonomic of the PARADE CONNECT shoes
Time frame: within 24 hours after removal of the device
Preferred shape for the PARADE CONNECT shoes
Time frame: within 24 hours after removal of the device
Acceptability of the PARADE CONNECT shoes: Average acceptability score
Time frame: within 24 hours after removal of the device
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cédric Annweiler, MD, PhD principal investigator
University Hospital, Angers
1 site in 1 country: see every site and its status.
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.