Sense4Safety Intervention

Обзор

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

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

Вторичные конечные точки (1)

• Fear of Falling [Срок оценки: 0, 3, 6 mos.]

Критерии участия

Критерии включения

• 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)

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• University of Pennsylvania — Philadelphia

Идентификаторы

NCT: NCT07220668 · GM1XX56LEP58 · 1R01AG090377-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗