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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03114800
Other study ID # PRO16120412
Secondary ID
Status Completed
Phase N/A
First received April 10, 2017
Last updated October 5, 2017
Start date August 9, 2017
Est. completion date August 30, 2017

Study information

Verified date October 2017
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date August 30, 2017
Est. primary completion date August 30, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
E-Scale
The E-Scale is comprised of a series of weight monitoring 'pods' and a set of software modules that facilitate data transfer and analysis.

Locations

Country Name City State
United States Bakery Square Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Jonathan Pearlman

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Weight change Weight change at each load cell 1 hour
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