Falls are the leading cause of US injury deaths among people 65 and older, and at least two of every three residents of skilled nursing facilities (SNF) fall at least once each year. This Phase I study will assess key parameters of a new wireless, non-restraint device to prevent falls in these high-risk individuals. The device has undergone limited but successful clinical testing, resulting in a statistically significant 91% reduction in falls among 47 patients. It is waterproof and disposable, can be worn unobtrusively for several days, and the FDA has designated it Non-Significant Risk for clinical trials. In Phase I, we will accumulate approx. 2500 patient-days of intervention data in 50 high-risk patients weeks in order to 1) quantify the sensitivity of the device to detect high-fall risk behavior and 2) assess adverse skin reaction. Phase I will also provide the opportunity to quantify attempts to get up unassisted, as well as quantify witnessed versus unwitnessed falls. Reducing falls in this high-risk population would be the first time an intervention device has been able to clearly demonstrate a reduction in falls. Given the US direct costs of falls in those over 65 was $20 billion in 1994, even a small reduction in fall rate would suggest significant potential for commercial success.
