Monitoring Movement for Pressure Ulcer Prevention
Primary Purpose
Pressure Ulcer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
E-Scale
Sponsored by
About this trial
This is an interventional device feasibility trial for Pressure Ulcer
Eligibility Criteria
Inclusion Criteria:
- Age 18 and older
Exclusion Criteria:
- Not able to independently get onto a bed and reposition themselves
- Skin lesions in the area where sensors will be placed
Sites / Locations
- Bakery Square
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
E-Scale
Arm Description
Weight monitoring
Outcomes
Primary Outcome Measures
Weight change
Weight change at each load cell
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03114800
Brief Title
Monitoring Movement for Pressure Ulcer Prevention
Official Title
Monitoring Movement for Pressure Ulcer Prevention
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
August 9, 2017 (Actual)
Primary Completion Date
August 30, 2017 (Actual)
Study Completion Date
August 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jonathan Pearlman
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this work is to develop and test an automated movement detection monitoring tool that could lead to reduced burden on clinicians and in-turn reduce pressure ulcer incidence rates. Ten healthy participants will perform video-recorded bed movements while weight distribution and interface pressures at bony prominences on the pelvis are recorded.
Detailed Description
The incidence rate and subsequent costs of preventable pressure ulcers is astounding. Although pressure ulcer risk assessment tools and prevention approaches have been a topic of research and for many years, the incidence rate has remained relatively consistent. One reason that progress has not been made to lower the incidence rate is that there is no objective monitoring tool to determine how much a person is moving or is being moved in their bed. Current practices are time-intensive and have not yet leveraged intelligent monitoring technology that could reduce clinical burden and increase accuracy of the risk assessment and efficacy of prevention protocols. The goal of this work is to develop and test an automated movement detection monitoring tool that could lead to reduced burden on clinicians and in-turn reduce pressure ulcer incidence rates. This monitoring tool will be an extension of our intelligent bed sensor we developed named the Embedded Scale, or E-Scale. The E-Scale currently has software modules that detect bed exit, individual weight, and multi-person weight. The project described here would develop a movement module for the E- Scale to monitor people's movements in bed in an attempt to eventually reduce incidence of pressure ulcers in clinical care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
E-Scale
Arm Type
Experimental
Arm Description
Weight monitoring
Intervention Type
Device
Intervention Name(s)
E-Scale
Other Intervention Name(s)
Embedded Scale
Intervention Description
The E-Scale is comprised of a series of weight monitoring 'pods' and a set of software modules that facilitate data transfer and analysis.
Primary Outcome Measure Information:
Title
Weight change
Description
Weight change at each load cell
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18 and older
Exclusion Criteria:
Not able to independently get onto a bed and reposition themselves
Skin lesions in the area where sensors will be placed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Pearlman, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bakery Square
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD data will be used to develop a proprietary algorithm
Learn more about this trial
Monitoring Movement for Pressure Ulcer Prevention
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