Testing the Effectiveness of a Falls Prevention System

High Risk for Falling Clinical Trial

Official title:

Testing the Effectiveness of a Falls Prevention System

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03678402
• Other study ID #: 2018H0303
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 24, 2019
• Est. completion date: June 30, 2024

Study information

• Verified date: September 2022
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this single arm intervention study is to determine if the fall rate (as measured by falls per 1000 patient days) for patients designated "high fall risk" decreases with the use of the PUP™ [Patient is UP Falls Prevention System] when compared to the historical falls rate data for the prior 12 months from those same nursing units within the OSUWM Brain & Spine Hospital.

Description:

The purpose of this single arm intervention study is to determine if the fall rate (as measured by falls per 1000 patient days) for patients designated "high fall risk" decreases with the use of the PUP™ [Patient is UP Falls Prevention System] when compared to the historical falls rate data for the prior 12 months from those same nursing units within the OSUWM Brain & Spine Hospital. All Brain and Spine Hospital patients will be evaluated as to fall risk using the current fall risk assessment tool employed by OSU Medical Center and administered in the usual and customary fashion upon evaluation on the floor and Pod. Patients who are determined to be at a high fall risk will be approached to participate. Those patients who consent to participate in the study will remain in the study until a nurse removes the patient from high risk fall status or the participant has been discharged from the hospital. Any patient fall will to be reported and evaluated following current processes and procedures developed by the OSU Brain and Spine Institute as maintained with IHIS; the PUP™ as the intervention for this study will be an adjunct to those fall prevention processes already in place.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 521
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years of age or older;

• All high-risk fall patients, eighteen years of age or older, who are admitted to the OSU Brain and Spine Hospital on Floors 8 South, 9 South, 10 South, 8 East, 9 East or 10 East. Patients will undergo a pre-assessment as per OSUWMC procedure to determine if they are a high-fall risk.

Exclusion Criteria:

• Patients whose medical condition as assessed by the PI prohibits their participation in the program, which would include among others the following: patients who lack the capacity to consent, patients with an anatomy or wound issue on their feet or around their calves that would bar them from wearing socks on either foot, and/or patients for whom the sock would impede medical treatment.

Related Conditions & MeSH terms

• High Risk for Falling

Intervention

Device:
• PUP™ sock
The Palarum Fall Prevention System that includes the PUP™ (Patient is Up) System, is made upon of seven tangible elements: an inpatient room Android tablet (IRT), a nurse station Android monitor (HUC), a local server (PLS), a cloud server (PCS), a Bluetooth Low Energy beacon(s), an Android smart watch, and an e-textile sock connected sensor transmitter (PUP™ sock). The PUP™ sock monitors and transmits pressure, force, acceleration and motion data.

Locations

Country	Name	City	State
United States	The Ohio State University Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Tammy Moore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High Risk Fall Rate	To determine if the fall rate (as measured by falls per 1000 patient days) for patients designated "high fall risk" decreases with the use of the intervention (Patient is UP fall prevention technology [PUP™ ]) when compared to historical NDNQI data for the prior 12 months ("Benchmark Data") from nursing units where the intervention is being undertaken.	hospital stay (on average 5 days)