BioButton Among Nursing Home Residents

NCT ID: NCT06665685

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-11
• Study Completion Date: 2025-07-18

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.

Conditions

Gait; Medication Induced Gait Disturbances

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

BioButton Device

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Providing Clinical Care with BioButton Device

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jewish Healthcare Foundation

UNKNOWN

Sponsor Role: collaborator

Charles Lin

OTHER

Sponsor Role: lead

Responsible Party

Charles Lin

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Charles Lin, MD

Role: PRINCIPAL_INVESTIGATOR

UPMC, University of Pittsburgh

Locations

UPMC Canterbury Place

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY24050088

Identifier Type: -

Identifier Source: org_study_id