Clinical Evaluation of a Wireless Monitoring Device to Reduce Falls in the Elderly and Others at High Risk of Falling
Completed · Phase 1/Phase 2
Conditions studied: Accidental Falls, Fractures, Injuries
In brief
Falls are a public health problem of significant social and economic significance. No primary intervention devices have been shown to be effective in reducing falls and associated injuries. The objective of this study was to determine whether the new wireless FallSaver device reduces falls and fall-related injuries in elderly skilled nursing facility (SNF) residents. A randomized, prospective, open-label, cross-over study was conducted over a six-month period. The FallSaver device reduced the frequency of falls by 50% and fall-related injuries by 82% in 43 elderly at-risk SNF residents studied over 4,222 patient-days. The device and associated patch enclosure was well tolerated and devoid of serious problems. Significant cost savings and fewer reductions in quality of life are possible if fall-related injuries can be reduced.
Key facts
- Study ID
- NCT00249743
- Run by
- NOCwatch International
- People needed
- 50
- Starts
- 2004-12-01
- Expected to finish
- 2005-07-01
- Last updated by the study team
- 2006-05-29
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Residents of a skilled nursing facility. An anticipated institutional stay of at least 120 days. Individuals with a high risk of falling according to the Morse scale (a score of 55+).
You may not qualify if…
- Individuals who were allowed to self-ambulate. Individuals with a history of adverse reactions to medical adhesives. Individuals with a history or presence of significant skin breakdown on the legs.
Where it is running
- Spokane Veterans Homes — Spokane, Washington, United States
Full record on ClinicalTrials.gov
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