NCT04067193

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 26, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

October 30, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2021

Completed
Last Updated

October 4, 2019

Status Verified

September 1, 2019

Enrollment Period

1.5 years

First QC Date

August 21, 2019

Last Update Submit

October 2, 2019

Conditions

Keywords

old peoplefallelderlyfall detectionusabilitysatisfactionergonomyshoes

Outcome Measures

Primary Outcomes (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.

    within 24 hours after removal of the device

Secondary Outcomes (4)

  • Satisfaction of the PARADE CONNECT shoes: recommendation scale

    within 24 hours after removal of the device

  • Ergonomic of the PARADE CONNECT shoes

    within 24 hours after removal of the device

  • Preferred shape for the PARADE CONNECT shoes

    within 24 hours after removal of the device

  • Acceptability of the PARADE CONNECT shoes: Average acceptability score

    within 24 hours after removal of the device

Study Arms (3)

old geriatric inpatients

usability assessment after 24 to 72 hours of possible use of the device (PARADE CONNECT shoes)

Other: usability survey

unformal caregivers

usability assessment after 24 to 72 hours of possible use of the device (PARADE CONNECT shoes) by their relative

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

Other: usability survey

Interventions

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

old geriatric inpatientsprofessional caregiversunformal caregivers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Angers University Hospital

Angers, 49933 cedex 9, France

Location

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Cédric Annweiler, MD, PhD

    Angers University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cédric ANNWEILER, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2019

First Posted

August 26, 2019

Study Start

October 30, 2019

Primary Completion

April 30, 2021

Study Completion

May 3, 2021

Last Updated

October 4, 2019

Record last verified: 2019-09

Locations