Operability and Implementation of a Patient Motion Monitoring System Using Wireless Body Worn Sensors (GFD1)
Primary Purpose
Accidental Falls, Gait, Unsteady
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Smart Slipper
Belt-Clip Sensor
Sponsored by
About this trial
This is an interventional prevention trial for Accidental Falls
Eligibility Criteria
Inclusion Criteria:
- At least 30 day resident of Garrison.
- Deemed mentally competent by primary care provider to make decisions regarding their daily shoe wear.
- A resident prone to falls is eligible.
- Willing to wear shoes and offer high level of compliance to study
- Able to provide informed consent
- Able to complete survey
- Age range: 45-85 yrs
Exclusion Criteria:
1. Unwilling to participate 2. Not mentally competent to provide informed consent
-
Sites / Locations
- Garrison Geriatric Education and Care Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Wireless Body-Worn Sensors
Arm Description
Elderly patients will wear sensors (Smart Slippers and a belt-clip sensor) as they go about their daily life in a geriatric care center.
Outcomes
Primary Outcome Measures
Detection of Fall Incidences
Participants will be monitored for falls. The detection of fall events as determined by the sensors will be compared to the fall log kept by Garrison Geriatric Center.
Secondary Outcome Measures
Full Information
NCT ID
NCT02272933
First Posted
October 21, 2014
Last Updated
December 11, 2019
Sponsor
Texas Tech University Health Sciences Center
Collaborators
Texas Tech University
1. Study Identification
Unique Protocol Identification Number
NCT02272933
Brief Title
Operability and Implementation of a Patient Motion Monitoring System Using Wireless Body Worn Sensors
Acronym
GFD1
Official Title
Operability and Implementation of a Patient Motion Monitoring System Using Wireless Body Worn Sensors
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Withdrawn
Why Stopped
No Study Enrollment
Study Start Date
August 2014 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas Tech University Health Sciences Center
Collaborators
Texas Tech University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this observational study, a motion monitoring system including body-worn sensors, communication portals, data capture system, and algorithms will be tested with geriatric patients in Garrison Geriatric Education and Care Center (Lubbock, TX). The study is part of a long-term effort to improve the quality of life and safety of geriatric patients by using autonomous systems that can alert care givers of mobility issues and falls.
Detailed Description
Medical monitoring systems have become an important area of research and development due to the possibility of allowing improved quality of life and care while reducing overall medical costs.
Significance of the study:
The study is significant because it will allow researchers to understand the efficacy of the autonomous sensor system used with actual residents of a geriatric care center. This study is one of the first attempts to monitor movements of geriatric residents as they go about their activities of daily living. This type of system has the potential to improve the quality of life and safety of geriatric patients.
Goals:
The development of autonomous patient monitoring technologies that will eventually improve the quality of life and safety of patients in geriatric care facilities and other environments.
Determine the performance and usability of the wearable sensor system in a geriatric care facility with actual residents going about their daily lives.
Specific Aims:
Determine performance of motion data collect ion system for monitoring geriatric residents as they go about their daily life in a geriatric center
Determine tolerability of wearing sensors by geriatric residents
Understand how medical staff interacts with monitored residents and the sensor devices
Determine if the sensor system's algorithms can identify falls
Objectives:
Analyze the motion data generated by the system to determine system performance. The list of performance metrics will include: (a) system up-time, (b) continuity of data collection (c) sensor device failure rate, (d) sensor device battery life (e) simultaneous collection of data when multiple monitored residents are in the same localized area.
Assess the tolerability of wearing the devices over the course of a day using a survey administered to residents.
Assess the usability of the sensor system using a survey administered to care givers.
Compare events flagged as falls by system algorithms with the fall log produced by Garrison staff, cross-verified against personal fall logs, to determine the ability of the system to detect falls.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Accidental Falls, Gait, Unsteady
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Wireless Body-Worn Sensors
Arm Type
Experimental
Arm Description
Elderly patients will wear sensors (Smart Slippers and a belt-clip sensor) as they go about their daily life in a geriatric care center.
Intervention Type
Device
Intervention Name(s)
Smart Slipper
Intervention Description
The shoe measures foot pressure and motion allowing gait to be quantified.
Intervention Type
Device
Intervention Name(s)
Belt-Clip Sensor
Intervention Description
The sensor measures acceleration of the body allowing falls to be detected.
Primary Outcome Measure Information:
Title
Detection of Fall Incidences
Description
Participants will be monitored for falls. The detection of fall events as determined by the sensors will be compared to the fall log kept by Garrison Geriatric Center.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
At least 30 day resident of Garrison.
Deemed mentally competent by primary care provider to make decisions regarding their daily shoe wear.
A resident prone to falls is eligible.
Willing to wear shoes and offer high level of compliance to study
Able to provide informed consent
Able to complete survey
Age range: 45-85 yrs
Exclusion Criteria:
1. Unwilling to participate 2. Not mentally competent to provide informed consent
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ron Banister, MD
Organizational Affiliation
Texas Tech University Health Sciences Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Garrison Geriatric Education and Care Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79415
Country
United States
12. IPD Sharing Statement
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Operability and Implementation of a Patient Motion Monitoring System Using Wireless Body Worn Sensors
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