Skip to content

Sense4Safety Intervention

Sense4Safety Intervention

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07220668
Acronym
Sense4Safety
Enrollment
200
Registered
2025-10-24
Start date
2026-02-19
Completion date
2030-03-01
Last updated
2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment

Keywords

fall prevention, mild cognitive impairment, exercise training

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.

Interventions

BEHAVIORALSense4Safety

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.

Sponsors

University of Pennsylvania
Lead SponsorOTHER
National Institute on Aging (NIA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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)

Design outcomes

Primary

MeasureTime frameDescription
Gait Speed0, 3 and 6 monthsUsual gait speed (m/s)
Lower extremity strength and functional mobility0, 3, 6 mos.Instrumented 30-second chair stand
Functional mobility and fall risk0, 3, 6 mos.Instrumented Timed Up \& Go (TUG) Test
Static balance in narrow stance positions0, 3, 6 mos.Instrumented 90-second balance test

Secondary

MeasureTime frameDescription
Fear of Falling0, 3, 6 mos.measures the level of concern about falling during 16 social and physical activities inside and outside the home whether or not the person actually does the activity

Countries

United States

Contacts

CONTACTSean Harrison, MPH
seanha@nursing.upenn.edu215-898-0757

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026