Clinical trial NCT06665685: BioButton Among Nursing Home Residents
Official title: Using Gait Data to Inform Prescription Practice Among Nursing Home Residents to Reduce Medication-Induced Gait Disturbances
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gait
Medication Induced Gait Disturbances
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Jewish Healthcare Foundation
First posted: 2024-10-30
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study design will enroll arm 1 of 60 patients who will wear the device, BioButton, during their nursing home care. Arm 2 will consist of 10 nurses who have been assigned to care for one or more of the patients in Arm 1 to discuss device feasibility in terms of clinical care.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Participant safety
timeFrame: 30-days
measure: Protocol compliance
timeFrame: 30-days
measure: Acceptability
timeFrame: 30-days
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Canterbury Place
state: Pennsylvania
Study officials:
affiliation: UPMC, University of Pittsburgh
name: Charles Lin, MD
role: PRINCIPAL_INVESTIGATOR
References: