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ZeroFall - Reliability Testing of Optical Sensor to Detect Bed Exit for Patients in Hospital

NCT ID: NCT03901976

Last Updated: 2020-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-25

Study Completion Date

2020-11-05

Brief Summary

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Falls are one of the most common NHS adverse events. With an increasing number of frail elderly patients being admitted this risk is likely to increase. In order to be able to assist patients with bed exit in a timely manner monitoring might be of help. In ZeroFall we will test the reliability of monitoring devices to notify care givers if a patient is attempting to exit the bed.

Detailed Description

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In ZeroFall we intend to observe patients on risk of fall with two different devices during their hospital stay: The information from a no-touch optical sensing device that analyses movement and an under the mattress sensor that has already been used in a previous study at Bangor. Both are compatible with an existing monitoring system by Philips Healthcare and CE marked.

Conditions

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Delirium of Mixed Origin

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

The study has several distinct phases:

* Silent Phase: The devices run in the background, activity is blinded for clinicians, settings are optimized by the research team.
* Run-In Phase: Bed exit notifications are turned on, notifications will be configurable for acceptability by clinical teams. Data extraction and data evaluation will be tested.
* Phase I: Data collection of bed exit data of sensors as well as data related to falls
* Phase II: Data collection of bed exit data with optimization of predictive algorithms
* Phase III: Data collection for validation using predictive data for early notification
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Bed Exit Detection On

prevention of fall by a true bed exit detection

Group Type OTHER

bed exit detection

Intervention Type DEVICE

bed exit detection to avoid patients fall

Interventions

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bed exit detection

bed exit detection to avoid patients fall

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Adult patients with risk of fall more than 24 hours on the ward

Exclusion Criteria

Patients with predominantly palliative needs
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Philips Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christian P Subbe, MD

Role: PRINCIPAL_INVESTIGATOR

Ysbyty Gwynedd Hospital

Locations

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Ysbyty Gwynedd

Bangor, Wales, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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YGB-PH-CS-BD-2018-02-18

Identifier Type: -

Identifier Source: org_study_id