Sense4Safety Intervention

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT07220668
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Mild Cognitive Impairment

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Feb 19, 2026
Status verified
Mar 2026
Primary completion
Feb 28, 2030
Completion
Mar 31, 2030

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • No Intervention: Control Group
    Participants receive no interventional component, standard care
  • Experimental: Intervention Group
    Participants receive the Sense4Safety Intervention

Primary Outcome Measure

Gait Speed [ Time Frame: 0, 3 and 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19104-

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University of Pennsylvania· Philadelphia, PA

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