Recruiting
Phase 1
Phase 2

Sense4Safety

Sponsor:

University of Pennsylvania

Code:

NCT07220668

Conditions

Mild Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Sense4Safety

Study Details

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 ID

NCT07220668

Start date

Feb 19, 2026

Status verified date

Mar, 2026

Completion date

Mar, 2030

Anticipated

Primary completion date

Feb 28, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Control Group

Participants receive no interventional component, standard care

experimental: Intervention Group

Participants receive the Sense4Safety Intervention

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.

Primary outcome measure

  • Gait Speed [ Time Frame: 0, 3 and 6 months ]
  • Lower extremity strength and functional mobility [ Time Frame: 0, 3, 6 mos. ]
  • Functional mobility and fall risk [ Time Frame: 0, 3, 6 mos. ]
  • Static balance in narrow stance positions [ Time Frame: 0, 3, 6 mos. ]

Central Contacts and Locations

Central contacts

Locations

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

More Information

Sponsor

University of Pennsylvania

Last update posted

Mar 19, 2026

Last verified

Mar, 2026

Keywords

  • fall prevention
  • mild cognitive impairment
  • exercise training

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-03-19.