BioButton Among Nursing Home Residents

NCT06665685 | Terminated FDA Device

• 1 other identifier: STUDY24050088
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Gait; Medication Induced Gait Disturbances

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Patient Group

EXPERIMENTAL

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

Nurse Group

EXPERIMENTAL

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

Interventions

Providing Clinical Care with BioButton Device 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.

Nurse Group

BioButton Device 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.

Patient Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Charles Lin: lead
• Jewish Healthcare Foundation: collaborator

Study Sites (1)

UPMC Canterbury Place

Pittsburgh, Pennsylvania, 15201, United States

Location

Study Officials

• Charles Lin, MD

  UPMC, University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: October 30, 2024
• Study Start: March 11, 2025
• Primary Completion: July 18, 2025
• Study Completion: July 18, 2025
• Last Updated: January 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)