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NCT Number: NCT07220668

Sense4Safety Intervention

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Exclusion criteria

Exclusion criteria

include terminal illness, central nervous system condition such as stroke or Parkinson's disease, diagnosis of dementia, severe vision or hearing deficits, and reliant on wheelchair or scooter within living quarters.

Treatment and study plan

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.

Other names: Fall Prevention Intervention

Primary outcomes

  1. Gait Speed

    Time frame: 0, 3 and 6 months

    Usual gait speed (m/s)

  2. Lower extremity strength and functional mobility

    Time frame: 0, 3, 6 mos.

    Instrumented 30-second chair stand

  3. Functional mobility and fall risk

    Time frame: 0, 3, 6 mos.

    Instrumented Timed Up & Go (TUG) Test

  4. Static balance in narrow stance positions

    Time frame: 0, 3, 6 mos.

    Instrumented 90-second balance test

Secondary outcomes

  1. Fear of Falling

    Time frame: 0, 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

Study contacts

Contact information is provided by the study sponsor or research team.

Sean Harrison, MPH

CONTACT

[email protected]

215-898-0757

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: Sense4Safety

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Oct 24, 2025
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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