BioButton Among Nursing Home Residents

Using Gait Data to Inform Prescription Practice Among Nursing Home Residents to Reduce Medication-Induced Gait Disturbances

This pilot study will explore the use of the BioIntellisense BioButton, a remote wearable multi-parameter monitor, to identify gait disturbances that occur as a side effect of polypharmacy.

Study Overview

• Status: Terminated
• Conditions: Gait; Medication Induced Gait Disturbances
• Intervention / Treatment: Device: BioButton Device; Device: Providing Clinical Care with BioButton Device

Detailed Description

By 2030, an anticipated seven adults over 65 years old are projected to die every hour from a fall in the United States. This highlights the growing percentage of the elderly in our population and the impact of falls on them. Nationally, over 25% of older adults report falling each year and falls are the leading cause of fatal and non-fatal injuries. In Pennsylvania, 30% of older adults report falling each year, an underreported value that can be as high as 60%. The cost of care for falls is over $50 billion annually in the United States according to the Centers for Disease Control (CDC). Nursing home residents are especially at risk; among nursing home residents, the risk of falling is 2x greater than community residents.

Nursing home residents who take multiple medications especially antidepressants, anxiolytics, and blood pressure drugs have an increased risk for falling. Polypharmacy especially the use of five or more medications is significantly associated with a 21% increase of falls. Unfortunately, gait data is not routinely collected or available to geriatric clinicians for making medication decisions. Empowering clinicians with gait data can be a powerful piece of the puzzle; this information may help them decide whether the benefit of starting a new anti-hypertensive or mood medication is worth the risk.

Clinicians informed with gait data can make better medication decisions for their elderly patients; they will be able to consider gait disturbance and fall risk in their clinical judgement. As a result, gait data from continuous wearable technology can adjust medication practices, and reduce medication-induced falls. Moreover, the concept for gait-informed prescription practice complements the 4Ms (what matters, medication, mentation, and mobility) employed by age-friendly health systems. Continuous gait data can inform the implementation of the 4Ms by (1) engaging patients and their families about their care priorities related medications and their impact on gait, (2) adjusting medications that affect mobility, and (3) addressing depression treatment with behavioral modifications instead of medications. Results from this project can inform future studies that will move the needle towards implementing care practices consistent with the 4Ms.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15201
      • UPMC Canterbury Place

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age >18yrs
• Presence of gait documentation in EMR

Exclusion Criteria:

• Age <18yrs
• Non-English-speaking patients
• Patients who cannot provide consent due to cognitive status
• Bedbound, unable to stand

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient Group; Patients in this arm will wear the device, BioButton, continuous for 30 days as it collects physiologic and gait data, while receiving otherwise routine, standard of care.	Device: BioButton Device; BioButton is a remote wearable multi-parameter monitor, to identify gait disturbances that occur as a side effect of polypharmacy. This arm will be the patient wearing the device during their Nursing Home stay for 30-days.
Experimental: Nurse Group; Nurses caring for patients wearing the device, BioButton, will assist in placing and removing the device. Otherwise, they will provide routine, standard of care to the enrolled patients to determine the overall feasibility of the device for clinical care providers.	Device: Providing Clinical Care with BioButton Device; BioButton is a remote wearable multi-parameter monitor, to identify gait disturbances that occur as a side effect of polypharmacy. This arm will provide care for patients wearing the BioButton device during their Nursing Home stay for 30-days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant safety	This outcome measure will be reported via the % of patients who reported experiencing adverse events related to wearing the device (skin irritations, significant discomfort, etc.)	30-days
Protocol compliance	This outcome measure will be reported via the % of patients who were able to wear the device for the full 30-days.	30-days
Acceptability	This outcome measure will be reported via % of nurses who report that 'Yes' to the question: Would you recommend the patch to other nurses? on their acceptability survey.	30-days

Collaborators and Investigators

• Sponsor: Charles Lin
• Collaborators: Jewish Healthcare Foundation
• Investigators: Principal Investigator: Charles Lin, MD, UPMC, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2025
• Primary Completion (Actual): July 18, 2025
• Study Completion (Actual): July 18, 2025

Study Registration Dates

• First Submitted: October 29, 2024
• First Submitted That Met QC Criteria: October 29, 2024
• First Posted (Actual): October 30, 2024

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 9, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: STUDY24050088

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No