BioButton Among Nursing Home Residents

Not Applicable

Recruiting

• Conditions: Gait; Medication Induced Gait Disturbances

• Registration Number: NCT06665685
• Lead Sponsor: Charles Lin

Brief Summary

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.

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 Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-29
• Study First Submitted QC: 2024-10-29
• Study First Posted: 2024-10-30
• Study Start: 2025-03-11
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-14
• Primary Completion: 2025-12-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Participant safety	30-days	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.)
Protocol compliance	30-days	This outcome measure will be reported via the % of patients who were able to wear the device for the full 30-days.
Acceptability	30-days	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.

Trial Locations

Locations (1)

UPMC Canterbury Place; 🇺🇸 Pittsburgh, Pennsylvania, United States