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

• ClinicalTrials.gov Identifier: NCT02272933
• Recruitment Status: Withdrawn
• First Posted: October 23, 2014
• Last Update Posted: December 13, 2019
• Sponsor: Texas Tech University Health Sciences Center
• Collaborator: Texas Tech University
• Information provided by (Responsible Party): Texas Tech University Health Sciences Center

Tracking Information

• First Submitted Date: October 21, 2014
• First Posted Date: October 23, 2014
• Last Update Posted Date: December 13, 2019
• Actual Study Start Date: August 2014
• Actual Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Operability and Implementation of a Patient Motion Monitoring System Using Wireless Body Worn Sensors
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Accidental Falls
• Gait, Unsteady

Intervention

• 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

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

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: December 11, 2019): 0
• Original Estimated Enrollment (submitted: October 21, 2014): 10
• Actual Study Completion Date: October 2017
• Actual Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

-

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 45 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02272933
• Other Study ID Numbers: L14-125
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Texas Tech University Health Sciences Center
• Study Sponsor: Texas Tech University Health Sciences Center
• Collaborators: Texas Tech University

Investigators

• Principal Investigator: Ron Banister, MD; Texas Tech University Health Sciences Center

• PRS Account: Texas Tech University Health Sciences Center
• Verification Date: December 2019