Fall Clinical Trial
— QumPreFallOfficial title:
Exploration and Comparison of Novel Technology-supported Methods for Early Fall Risk Detection and Fall Prevention Among Inpatients With Delirium
NCT number | NCT05391334 |
Other study ID # | QumEKNZV2 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | November 1, 2022 |
Est. completion date | June 30, 2024 |
During delirium patients are at risk of severe harm due to unattended bed-exits resulting in falls. This research intends to explore how effective alarming contact mats (CareMat®) in comparison to contactless bed-exit alarming devices (Qumea®) are to reduce the risk of unattended bed-exits and falls.
Status | Recruiting |
Enrollment | 78 |
Est. completion date | June 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: Admission at or transferal to DelirUnit. During Covid pandemic, patients will be enrolled into the study after the second negative Covid swab (PCR). Exclusion Criteria: Patients who have been sectioned and must be treated in a facility, whether they agree or not (under the mental health act) (Fürsorgliche Unterbringung). No proxy consent available due to language barriers; Missing legal proxy in case of lacking family network |
Country | Name | City | State |
---|---|---|---|
Switzerland | Universitäre Altersmedizin Felix Platter | Basel |
Lead Sponsor | Collaborator |
---|---|
University Department of Geriatric Medicine FELIX PLATTER | University of Basel, Velux Stiftung |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Falls | Number of patient falls in patient room | 6 months | |
Secondary | Bed-exit patterns | Qumea® provides the following bed-exit pattern categories: 'STANDING', 'SITTING, 'LYING' oder 'OUT_OF_BED' .
Unit is number/percentage of bed-exit patterns. Artificial intelligence algorithms provide automatized detected bed-exit patterns by a three dimensional radar (Qumea®) |
6 months | |
Secondary | Nurses' workload | Workload is defined as the time in minutes per patient and per day (24-hour period) that a nurse is present in each patient's room. This is measured as the time between activation (nurse enters room) and deactivation (nurse leaves room) of the Hospicall (the hospitals' patient call system) presence button by the nurse in each patient's room. Hospicall automatically generates a time stamp in the logbook of the Hospicall operating system when the presence button is activated and deactivated. | 6 months | |
Secondary | Time to confirm a CareMat® / Qumea® warning by nurse presence in room | Time difference in seconds between timestamps from onset of warning and confirmation of warning with presence button in patient room of bed-exit warning from bed-exit surveillence systems (Qumea® or CareMat®) to Hospicall (a decentralised, scalable patient call system).
It is the time a nurse needs to confirm a bed-exit warning from the bed-exit surveillence systems. |
6 months | |
Secondary | Delirium severity | Delirium severity is a score between 0 and 39 points on a 13-item 4-point (0-3) Lickert scale, as measured with the Delirium Rating Scale Revised 98 (DRS-R-98). A cut-off score of 15.5 points indicates delirium. The higher the score, the more severe is the delirium. For the prediction models, the DRS-R-98 scores (1) at admission, (2) the mean values of the course of delirium and (3) the difference between admission and discharge will be calculated. The measurements are conducted by the research team (PI or research assistants) during the stay on the delirium unit (on Mondays, Wednesdays and Fridays) and on the day before discharge. | 6 months | |
Secondary | Delirium duration | To determine the duration of delirium, the presence and/or severity of delirium is first measured with the modified Confusion Assessment Method for the Emergency Department (mCAM-ED). The mCAM-ED provides the following categories: (0) no delirium (1) probable delirium (2) definite delirium. Duration of delirium is measured in days between the first delirium positive mCAM-ED assessments (category 1 or 2) and the last delirium positive (category 1 or 2) mCAM-ED assessments. The mCAM-ED assessments are conducted by the research team (PI or research assistants) Mondays, Wednesdays and Fridays and on the day before discharge. | 6 months |
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