Digital Intelligent Assistant for Nursing Application (DIANA)

August 24, 2022 updated by: Thomas Munzer, MD, PhD, Geriatrische Klinik St. Gallen

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Falls detection rate
Time Frame: Through study completion, an average of 6 months
Number of falls detected by the system compared to falls detected by nursing staff members
Through study completion, an average of 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of toileting
Time Frame: Through study completion, an average of 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Geriatrische Klinik St. Gallen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2021

Primary Completion (ANTICIPATED)

April 30, 2023

Study Completion (ANTICIPATED)

July 31, 2023

Study Registration Dates

First Submitted

May 11, 2020

First Submitted That Met QC Criteria

May 13, 2020

First Posted (ACTUAL)

May 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 25, 2022

Last Update Submitted That Met QC Criteria

August 24, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BASEC 20-00904

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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