Operability and Implementation of a Patient Motion Monitoring System Using Wireless Body Worn Sensors (GFD1)
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ClinicalTrials.gov Identifier: NCT02272933 |
Recruitment Status :
Withdrawn
(No Study Enrollment)
First Posted : October 23, 2014
Last Update Posted : December 13, 2019
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Tracking Information | ||||
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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 |
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.
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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:
Objectives:
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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 |
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Condition ICMJE |
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Intervention ICMJE |
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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:
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Withdrawn | |||
Actual Enrollment ICMJE |
0 | |||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria: 1. Unwilling to participate 2. Not mentally competent to provide informed consent - |
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Sex/Gender ICMJE |
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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 |
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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 |