Digital Intelligent Assistant for Nursing Application

Dementia Clinical Trial

— DIANA  

Official title:

Digital Intelligent Assistant for Nursing Application Evaluation of 3-Dimensional Sensor Technology in Long Term Care and Acute Geriatrics. A Single Center Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04393272
• Other study ID #: BASEC 20-00904
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Delirium
• Delirium in Old Age
• Dementia
• Enuresis
• Fall in Nursing Home
• Fecal Incontinence
• Frailty
• Frailty Syndrome
• Incontinence Bowel
• Incontinence, Urinary
• Urinary Incontinence

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