NCT07220668

Sense4Safety Intervention

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	Sense4Safety	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.

Timeline

• Start date: 2026-02-19
• Primary completion: 2030-02-28
• Completion: 2030-03-01
• First posted: 2025-10-24
• Last updated: 2026-03-19

Locations

1 site across 1 country: United States