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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03901976

Enrollment

Registered

2019-04-03

Start date

2019-03-25

Completion date

2020-11-05

Last updated

2020-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium of Mixed Origin

Brief summary

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

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.

Interventions

DEVICEbed exit detection

bed exit detection to avoid patients fall

Study design

Allocation

Intervention model

SEQUENTIAL

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

Patients with predominantly palliative needs

Design outcomes

Primary

Measure	Time frame	Description
Number of true bed exit detections vs number of false bed exit detections	12-15 months	A reference device and two observers will classify if a bed exit was true

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026