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

NCT03901976 | Terminated DMC

• 1 other identifier: YGB-PH-CS-BD-2018-02-18
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium of Mixed Origin

Outcome Measures

Primary Outcomes (1)

• Number of true bed exit detections vs number of false bed exit detections

  A reference device and two observers will classify if a bed exit was true

  12-15 months

Study Arms (1)

Bed Exit Detection On

OTHER

prevention of fall by a true bed exit detection

Device: bed exit detection

Interventions

bed exit detection DEVICE

bed exit detection to avoid patients fall

Bed Exit Detection On

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with predominantly palliative needs

Sponsors & Collaborators

• Philips Healthcare: lead

Study Sites (1)

Ysbyty Gwynedd

Bangor, Wales, LL57 2PW, United Kingdom

Location

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Christian P Subbe, MD

  Ysbyty Gwynedd Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: April 3, 2019
• Study Start: March 25, 2019
• Primary Completion: November 5, 2020
• Study Completion: November 5, 2020
• Last Updated: November 20, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)