Sense4Safety Intervention

NCT07220668 | Recruiting Phase 1

• 2 other identifiers: GM1XX56LEP581R01AG090377-01A1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Falls and fall-related injuries are significant public health issues for adults 65 years of age and older. Over a third of older adults (OA) fall each year and 10-20% of falls result in serious injuries such as fractures and head trauma. The annual direct medical costs in the US as a result of falls are estimated to exceed $50 billion, and this estimate does not include the indirect costs of disability, dependence, and decreased quality of life. This project targets community dwelling OA with mild cognitive impairment (MCI). MCI is a leading risk factor for falls in OA. Approximately 15%-20% of OA have MCI, and over 60% of OA with MCI fall annually - two to three times the rate of those without cognitive impairment. We have developed and pilot-tested an innovative technology-supported intervention called Sense4Safety to 1) identify escalating risk for falls real-time through in-home passive sensor monitoring; 2) employ machine learning to inform individualized alerts for fall risk; and 3) link 'at risk' older adults with a coach who will guide them in implementing evidence-based individualized plans to reduce fall-risk. The purpose of this study is to assess the effectiveness of Sense4Safety in reducing fall risk with a randomized clinical trial, and understand implementation factors to improve the scalability of Sense4Safety in diverse community settings.

Conditions

Mild Cognitive Impairment

Keywords

fall prevention; mild cognitive impairment; exercise training

Outcome Measures

Primary Outcomes (4)

• Gait Speed

  Usual gait speed (m/s)

  0, 3 and 6 months

• Lower extremity strength and functional mobility

  Instrumented 30-second chair stand

  0, 3, 6 mos.

• Functional mobility and fall risk

  Instrumented Timed Up \& Go (TUG) Test

  0, 3, 6 mos.

• Static balance in narrow stance positions

  Instrumented 90-second balance test

  0, 3, 6 mos.

Secondary Outcomes (1)

• Fear of Falling

  0, 3, 6 mos.

Study Arms (2)

Control Group

NO INTERVENTION

Participants receive no interventional component, standard care

Intervention Group

EXPERIMENTAL

Participants receive the Sense4Safety Intervention

Behavioral: Sense4Safety

Interventions

Sense4Safety BEHAVIORAL

Sense4Safety is a technology-enhanced intervention that includes multiple components: 1) in-home assessment; 2) tailored education and exercise; 3) passive monitoring and communication. The intervention is primarily via video-conferencing or phone, supplemented by in-home visits at intake, and 6 months to conduct in-person assessments.

Also known as: Fall Prevention Intervention

Intervention Group

Eligibility Criteria

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

You may qualify if:

• aged ≥ 65 years
• reside in senior living communities and plan to be in the area for more than 6 months
• be able to walk household distances
• score of at least 1 of 12 on the Short Physical Performance Battery (SPPB)
• meet MCI criteria (MCI is defined as a score ≥17 Montreal Cognitive Assessment)

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Sean Harrison, MPH

CONTACT

215-898-0757; seanha@nursing.upenn.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2025
• First Posted: October 24, 2025
• Study Start: February 19, 2026
• Primary Completion (Estimated): February 28, 2030
• Study Completion (Estimated): March 1, 2030
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)