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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04393272
Other study ID # BASEC 20-00904
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2021
Est. completion date July 31, 2023

Study information

Verified date August 2022
Source Geriatrische Klinik St. Gallen
Contact Thomas Münzer, MD
Phone +41712438880
Email thomas.muenzer@geriatrie-sg.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Three dimensional sensor technology (3DS) is available for fall detection and fall prevention (e.g. unwanted getting up in persons with risks for frequent falls) in several institutions in Europe and Switzerland. 3DS are capable to analyze completely anonymized data and alert nurses towards a dangerous (fall) or potentially dangerous (getting out of bed) event during day- and nighttime. Multi-sensor technology has been applied to assess activities of daily living in persons cognitive problems living at home. To our knowledge, 3DS technology has not been examined as part of a structured clinical protocol. In addition, the combination of two digital technologies (3DS and a server based software) as an integrative platform could help to develop algorithms to analyze complex human activities such as using a toilet. Automated analyses of such complex activities have the potential to support nursing staff in the future.


Recruitment information / eligibility

Status Recruiting
Enrollment 25
Est. completion date July 31, 2023
Est. primary completion date April 30, 2023
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility Inclusion criteria Informed consent given by person or caregiver Patients admitted - with or without cognitive decline for any reason - with acute and/or chronic conditions - after any kind of surgery Exclusion Criteria: 1. For Falls assessment by 3D sensors: • Based on the multifactorial risk for falls there are no exclusion criteria for falls assessment 2. For the development of toileting algorithm: - severe urine or fecal incontinence - permanent indwelling urinary catheter - permanent urinary or bowel stoma

Study Design


Intervention

Device:
Three dimensional sensor system designed for fall detection (Fearless)
Detection of falls in nursing home residents and acute geriatric hospital patiients

Locations

Country Name City State
Switzerland Geriatrische Klinik Sankt Gallen SG

Sponsors (1)

Lead Sponsor Collaborator
Geriatrische Klinik St. Gallen

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Other Assessment of toileting 3d sensor system data will be used to develop an algorithm for a complex activity such as using a toilet. The senors results will be compared with a Nurse led 12 step observation protocol. Parts of the activity model include: (1) enter the room, (2) go to the toilet, (3) take off clothes, (4) sit on the toilet, (5) clean oneself, (6) stand up, (7) get dressed, (8) flush the toilet, (9) go to the sink, (10) wash hands, (11) dry hands, (12) leave the room, as well as emergencies. Through study completion, an average of 6 months
Primary 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
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