Operability and Implementation of a Patient Motion Monitoring System Using Wireless Body Worn Sensors
NCT ID: NCT02272933
Last Updated: 2019-12-13
Study Results
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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WITHDRAWN
NA
INTERVENTIONAL
2014-08-31
2017-10-31
Brief Summary
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Detailed Description
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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:
1. Determine performance of motion data collect ion system for monitoring geriatric residents as they go about their daily life in a geriatric center
2. Determine tolerability of wearing sensors by geriatric residents
3. Understand how medical staff interacts with monitored residents and the sensor devices
4. Determine if the sensor system's algorithms can identify falls
Objectives:
1. 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.
2. Assess the tolerability of wearing the devices over the course of a day using a survey administered to residents.
3. Assess the usability of the sensor system using a survey administered to care givers.
4. 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Wireless Body-Worn Sensors
Elderly patients will wear sensors (Smart Slippers and a belt-clip sensor) as they go about their daily life in a geriatric care center.
Smart Slipper
The shoe measures foot pressure and motion allowing gait to be quantified.
Belt-Clip Sensor
The sensor measures acceleration of the body allowing falls to be detected.
Interventions
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Smart Slipper
The shoe measures foot pressure and motion allowing gait to be quantified.
Belt-Clip Sensor
The sensor measures acceleration of the body allowing falls to be detected.
Eligibility Criteria
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Inclusion Criteria
2. Deemed mentally competent by primary care provider to make decisions regarding their daily shoe wear.
3. A resident prone to falls is eligible.
4. Willing to wear shoes and offer high level of compliance to study
5. Able to provide informed consent
6. Able to complete survey
7. Age range: 45-85 yrs
Exclusion Criteria
\-
45 Years
85 Years
ALL
Yes
Sponsors
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Texas Tech University
OTHER
Texas Tech University Health Sciences Center
OTHER
Responsible Party
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Principal Investigators
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Ron Banister, MD
Role: PRINCIPAL_INVESTIGATOR
Texas Tech University Health Sciences Center
Locations
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Garrison Geriatric Education and Care Center
Lubbock, Texas, United States
Countries
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Other Identifiers
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L14-125
Identifier Type: -
Identifier Source: org_study_id