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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04067193
Recruitment Status : Not yet recruiting
First Posted : August 26, 2019
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Tracking Information
First Submitted Date August 21, 2019
First Posted Date August 26, 2019
Last Update Posted Date October 4, 2019
Estimated Study Start Date October 30, 2019
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 2, 2019)
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.
Original Primary Outcome Measures
 (submitted: August 21, 2019)
Measurement of acceptability [ Time Frame: baseline ]
Acceptability is assessed under actual conditions of use by patients aged 65 and over, hospitalized for falls, using a questionnaire created for this purpose, including single-choice questions
Change History
Current Secondary Outcome Measures
 (submitted: October 2, 2019)
  • Satisfaction of the PARADE CONNECT shoes: recommendation scale [ Time Frame: within 24 hours after removal of the device ]
    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.
  • Ergonomic of the PARADE CONNECT shoes [ Time Frame: within 24 hours after removal of the device ]
    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.
  • Preferred shape for the PARADE CONNECT shoes [ Time Frame: within 24 hours after removal of the device ]
    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.
  • Acceptability of the PARADE CONNECT shoes: Average acceptability score [ Time Frame: within 24 hours after removal of the device ]
    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.
Original Secondary Outcome Measures
 (submitted: August 21, 2019)
  • Aesthetics measurement [ Time Frame: baseline ]
    Aesthetics is assessed thanks to a questionnaire created for this purpose, including single-choice questions.
  • Comfort measurement [ Time Frame: baseline ]
    Comfort is assessed by using a questionnaire composed of numerical scale, satisfaction scales and single-choice questions created for this purpose.
  • Ergonomics measurement [ Time Frame: baseline ]
    Ergonomics is assessed by using a questionnaire composed of digital scale, and single-choice questions created for this purpose.
  • Reliability measurement [ Time Frame: baseline ]
    Reliability is assessed through a questionnaire composed of single-choice questions created for this purpose.
  • Autonomy measurement [ Time Frame: baseline ]
    Autonomy is assessed through a questionnaire composed of single-choice questions created for this purpose.
  • Measurement of ease of use [ Time Frame: baseline ]
    Ease of use is assessed thanks to a questionnaire composed of single-choice questions, created for this purpose
  • Measurement of robustness [ Time Frame: baseline ]
    Robustness is assessed using a questionnaire composed of single-choice questions, created for this purpose
  • Measurement of the price-quality ratio [ Time Frame: baseline ]
    The price-quality ratio is assessed thanks to a questionnaire composed of single-choice questions, created for this purpose
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Patients Hospitalised in Geriatrics
Intervention Other: usability survey
usability survey composed of subpart: System Usability Scale, questions about ergonomic, questions about design, question about global satisfaction.
Study Groups/Cohorts
  • old geriatric inpatients
    usability assessment after 24 to 72 hours of possible use of the device (PARADE CONNECT shoes)
    Intervention: Other: usability survey
  • unformal caregivers
    usability assessment after 24 to 72 hours of possible use of the device (PARADE CONNECT shoes) by their relative
    Intervention: 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
    Intervention: Other: usability survey
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: August 21, 2019)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 3, 2021
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Cédric ANNWEILER, MD, PhD 0241354725 ext +33 allegro@chu-angers.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04067193
Other Study ID Numbers 2019/49
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Angers
Study Sponsor University Hospital, Angers
Collaborators Not Provided
Investigators
Principal Investigator: Cédric Annweiler, MD, PhD Angers University Hospital
PRS Account University Hospital, Angers
Verification Date September 2019