Sense4Safety Intervention

NCT ID: NCT07220668

Last Updated: 2025-10-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-04-01
• Study Completion Date: 2030-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control Group

Participants receive no interventional component, standard care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention Group

Participants receive the Sense4Safety Intervention

Group Type: EXPERIMENTAL

Sense4Safety

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Fall Prevention Intervention

Eligibility Criteria

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 6 of 12 on the Short Physical Performance Battery (SPPB)
• meet MCI criteria (MCI is defined as a score ≥17 Montreal Cognitive Assessment)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1R01AG090377-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GM1XX56LEP58

Identifier Type: -

Identifier Source: org_study_id