Efficacy of Bed Mattress Sensor for Detecting Pre-fall Activities and Preventing Bedside Falls in Elderly in Residential Setting

NCT05490368 | Completed

• 1 other identifier: HKU_bedsensor_protocol_v3
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The study has 1 primary research question and 5 auxiliary research questions regarding the use of bed mattress sensor for detecting pre-fall activities in elderly residents in old-age home setting: Primary research question:

1. 1.Can bedside fall incidents per 1000 bed-days be reduced comparing the 6 months before and after the installation of the bed mattress sensor system, and compared to control group?
2. 2.Can the length of fall-related hospital stay shortens comparing the 6 months before and after the installation of the system and compared to control group?
3. 3.What are the differences in fall characteristics comparing the 6 months before and after the installation of the system and compared to control group?
4. 4.What is the number of different types of alerts and average time to turn off the alerts of the system (proxy measure of response time of the care staff), and how are they different to bed-exit alarm system?
5. 5.What are the immediate care delivery of the staff upon the alert of the system, and how are they different to bed-exit alarm system?
6. 6.What are the views and comments from the operation staff, residents and/or their family members on the usage of the bed mattress sensor?

Conditions

Technology

Keywords

Gerontechnology; Smart Healthcare Device; Digital Health Technology

Outcome Measures

Primary Outcomes (1)

• Numbers of bedside fall incidents 6 months before and after the installation of the system and between the two groups

  The numbers of bedside fall incidents per 1000 bed-days 6 months before and after the installation of the system will be compared by retrieving data from the fall reports.

  6 months before the 6-months trial period to the end of the 6-month trial period

Secondary Outcomes (7)

• The length of hospital stay due to bedside fall incidents before and after the use of the system and between the two groups

  6 months before the 6-months trial period to the end of the 6-month trial period

• Qualitative measure: Fall characteristics of residents before and after the use of the system and between the two groups

  6 months before the 6-months trial period to the end of the 6-month trial period

• The number of detector alerts made by the sensor

  From the start to the end of the 6-month trial period

• Average time in seconds to turn off the alert

  every day during the 6-month trial period

• The number of immediate care delivery of the staff upon the alert

  From the start to the end of the 6-month trial period

Study Arms (2)

Bed mattress sensor system

EXPERIMENTAL

The experimental group uses the new bed mattress sensor system for 6 months.

Device: Bed mattress sensor system

Control Group

NO INTERVENTION

In the control group, participants do not use any of the following bedside fall-prevention tools: bed-exit alarm system, ultra low bed, and ripple bed during the same 6-month period.

Interventions

Bed mattress sensor system DEVICE

The new sensor pad can detect any bed-exit activities, including stirring, sitting up, leaving, and out-of-bed. Audible message and alert to care staff can be customised in each participant. Whenever the system detects a change of bed-exit activity, an audible message will be played in the control box next to the resident's bed reminding the resident not to leave and that a care staff shall arrive shortly. Care staff at the nurse station will simultaneously receive the alert, as a sound and a visual figure on the dashboard, with the location and body position of the resident, and be prompted for a rapid and appropriate response. Care staff are allowed to customise each resident's alert settings, including time to alert and notification method.

Bed mattress sensor system

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Residents with fall history in the past year, or
• Residents with Morse Fall Scale score of 25 or higher (moderate to high fall risk)
• Operate the bed sensor system (i.e. provide related care and assistance upon the alerts of the system)
• Having participated in the main trial
• Able to verbally communicate in Cantonese as perceived by the staff of the related home
• Having participated in the main trial
• Witnessed the daily operation of the bed mattress sensor, as advised by the participating staff

You may not qualify if:

• Residents who are using bed-exit alarm system, ultra low beds or ripple bed (which are not suitable to use the mattress sensor)
• None
• None
• None
• None

Sponsors & Collaborators

• The University of Hong Kong: lead
• Haven of Hope Hospital: collaborator
• The Social Innovation and Entrepreneurship Development Fund, Hong Kong: collaborator

Study Sites (1)

Haven of Hope Woo Ping Care & Attention Home

Hong Kong, 00, Hong Kong

Location

Study Officials

• Yee Tak Cheung, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and group moderators cannot and will not be blinded to the intervention. Assessors of the follow-up outcomes and the research analysts will not be involved in the recruitment and intervention delivery, and will be blinded to the group allocation (single blindness).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor

Model Details: The care staff of the home will screen all residents for eligible residents with fall history in the past 12 months or with eligible Morse Fall Scale score. If the potential residents were assessed with Morse Fall Scale before 1 May 2022, Morse Fall Scale will be conducted again to update the score. In the experimental group, recruitment priority starts from those with a highest score in Morse Fall Scale until 10 participants are recruited. In recruiting suitable residents of the control group, the potential residents with similar Morse Fall Scale scores and similar profiles including gender, age, and fall history in the past 12 months to those of experimental group will be recruited. They and their family caregivers will be notified about the utilization about their fall records, and that the existing practice in fall prevention for them will not be altered during the trial. If they do not want to participate, they can notify the care staff (Opt-out participation).

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 5, 2022
• Study Start: August 16, 2022
• Primary Completion: February 15, 2023
• Study Completion: February 28, 2023
• Last Updated: March 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available for 10 years.

Locations

HK (1)