University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
NCT Number: NCT07220668
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.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Phase 1 / Phase 2
Philadelphia, Pennsylvania, 19104, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
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
Time frame: 0, 3 and 6 months
Usual gait speed (m/s)
Time frame: 0, 3, 6 mos.
Instrumented 30-second chair stand
Time frame: 0, 3, 6 mos.
Instrumented Timed Up & Go (TUG) Test
Time frame: 0, 3, 6 mos.
Instrumented 90-second balance test
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
Contact information is provided by the study sponsor or research team.
University of Pennsylvania
Other
Acronym: Sense4Safety
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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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