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Operability and Implementation of a Patient Motion Monitoring System Using Wireless Body Worn Sensors (GFD1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02272933
Recruitment Status : Withdrawn (No Study Enrollment)
First Posted : October 23, 2014
Last Update Posted : December 13, 2019
Sponsor:
Collaborator:
Texas Tech University
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center

Tracking Information
First Submitted Date  ICMJE October 21, 2014
First Posted Date  ICMJE October 23, 2014
Last Update Posted Date December 13, 2019
Actual Study Start Date  ICMJE August 2014
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2014)
Detection of Fall Incidences [ Time Frame: 6 months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Operability and Implementation of a Patient Motion Monitoring System Using Wireless Body Worn Sensors
Official Title  ICMJE Operability and Implementation of a Patient Motion Monitoring System Using Wireless Body Worn Sensors
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:

  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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Accidental Falls
  • Gait, Unsteady
Intervention  ICMJE
  • Device: Smart Slipper
    The shoe measures foot pressure and motion allowing gait to be quantified.
  • Device: Belt-Clip Sensor
    The sensor measures acceleration of the body allowing falls to be detected.
Study Arms  ICMJE Experimental: 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.
Interventions:
  • Device: Smart Slipper
  • Device: Belt-Clip Sensor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: December 11, 2019)
0
Original Estimated Enrollment  ICMJE
 (submitted: October 21, 2014)
10
Actual Study Completion Date  ICMJE October 2017
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. At least 30 day resident of Garrison.
  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:

1. Unwilling to participate 2. Not mentally competent to provide informed consent

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Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02272933
Other Study ID Numbers  ICMJE L14-125
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Texas Tech University Health Sciences Center
Study Sponsor  ICMJE Texas Tech University Health Sciences Center
Collaborators  ICMJE Texas Tech University
Investigators  ICMJE
Principal Investigator: Ron Banister, MD Texas Tech University Health Sciences Center
PRS Account Texas Tech University Health Sciences Center
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP