NCT04393272

Brief Summary

This is an observational study that intends to compare falls or fall-risk related alarms derived from a three-dimensional sensor system with the clinical reality definded by attending nurses.

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
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2021

Typical duration for all trials

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

May 11, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 19, 2020

Completed
12 months until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2022

Enrollment Period

2 years

First QC Date

May 11, 2020

Last Update Submit

August 24, 2022

Conditions

Keywords

3D sensorsfalls detectiontoileting algorithm

Outcome Measures

Primary Outcomes (1)

  • Falls detection rate

    Number of falls detected by the system compared to falls detected by nursing staff members

    Through study completion, an average of 6 months

Other Outcomes (1)

  • Assessment of toileting

    Through study completion, an average of 6 months

Interventions

Detection of falls in nursing home residents and acute geriatric hospital patiients

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Due to the observationa design, we will have no control group. All persons admitted to the rooms equipped with this novel technology are asked to participate.

You may qualify if:

  • with or without cognitive decline for any reason
  • with acute and/or chronic conditions
  • after any kind of surgery

You may not qualify if:

  • For Falls assessment by 3D sensors:
  • For the development of toileting algorithm:
  • severe urine or fecal incontinence
  • permanent indwelling urinary catheter
  • permanent urinary or bowel stoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geriatrische Klinik

Sankt Gallen, Canton of St. Gallen, 9000, Switzerland

RECRUITING

MeSH Terms

Conditions

FrailtyDementiaUrinary IncontinenceEncopresis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsSigns and Symptoms, DigestiveBehavioral SymptomsBehaviorElimination Disorders

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Geriatrics

Study Record Dates

First Submitted

May 11, 2020

First Posted

May 19, 2020

Study Start

May 1, 2021

Primary Completion

April 30, 2023

Study Completion

July 31, 2023

Last Updated

August 25, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations