Frailty SyndromeDIANANCT04393272
Digital Intelligent Assistant for Nursing Application
An observational study of Frailty Syndrome and Fall in Nursing Home, run by Geriatrische Klinik St. Gallen at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Frailty Syndrome, Fall in Nursing Home, Dementia
- What is being tested?
- Three dimensional sensor system designed for fall detection (Fearless)
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 May 2021to 31 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
None listed.
Who cannot join
- For Falls assessment by 3D sensors:
- Based on the multifactorial risk for falls there are no exclusion criteria for falls assessment
- For the development of toileting algorithm:
- severe urine or fecal incontinence
- permanent indwelling urinary catheter
- permanent urinary or bowel stoma
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Geriatrische Klinik
Sankt Gallen, Canton of St. Gallen, 9000
Thomas Münzer, MD, +41712438880, thomas.muenzer@geriatrie-sg.ch
About this study
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
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.
Read the 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.
- Conditions
- Frailty Syndrome, Fall in Nursing Home, Dementia, Delirium in Old Age, Incontinence, Urinary, Incontinence Bowel
- Being tested
- Three dimensional sensor system designed for fall detection (Fearless)
- Keywords
- 3D sensors, falls detection, toileting algorithm
- Medical subject headings
- Frailty, Dementia, Urinary Incontinence, Encopresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three dimensional sensor system designed for fall detection (Fearless)Device
Detection of falls in nursing home residents and acute geriatric hospital patiients
What is being measured
The primary outcome is the main question the study is designed to answer.
Falls detection rate
Number of falls detected by the system compared to falls detected by nursing staff members
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start1 May 2021
- Primary completion30 Apr 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frailty SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Geriatrische Klinik St. Gallen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Munzer, MD, PhD, Geriatrische Klinik St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393272
- Sponsor's protocol ID
- BASEC 20-00904
- Acronym
- DIANA
- Status last verified
- Aug 2022
- First submitted
- 11 May 2020
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04393272
- Acronym / sponsor ID
- DIANA / BASEC 20-00904
- Conditions
- Frailty Syndrome, Fall in Nursing Home, Dementia, Delirium in Old Age, Incontinence, Urinary, Incontinence Bowel
- Keywords
- 3D sensors, falls detection, toileting algorithm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Geriatrische Klinik St. GallenUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- For Falls assessment by 3D sensors:
- For the development of toileting algorithm:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Three dimensional sensor system designed for fall detection (Fearless)Detection of falls in nursing home residents and acute geriatric hospital patiients | Device | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty Syndrome and Fall in Nursing Home, run by Geriatrische Klinik St. Gallen at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Münzer, MD (+41712438880, thomas.muenzer@geriatrie-sg.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Falls detection rate (time frame: Through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.