Clinical Evaluation of a Wireless Monitoring Device to Reduce Falls in the Elderly and Others at High Risk of Falling
Device: FallSaver (formerly called NOCwatch)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||NIH-NIA SBIR Phase I/II Study: Clinical Evaluation of a Device to Reduce Patient Falls|
- Falls and fall-related injuries.
- Falls resulting from documented attempts to stand or ambulate without assistance.
- Skin tolerance to the adhesive.
|Study Start Date:||December 2004|
|Estimated Study Completion Date:||July 2005|
OBJECTIVE. No existing devices have proven effective in preventing falls in at-risk individuals. The objective of this study was to determine whether the FallSaver device reduces falls and fall-related injuries in elderly skilled nursing facility (SNF) residents.
DESIGN. This was a randomized, prospective, open-label, cross-over study conducted over a six-month period.
SETTING: The study took place in a 100-bed State Veterans SNF in Washington State.
PARTICIPANTS. Forty-four subjects with anticipated institutional stays of at least 120 days participated in the study. The subjects’ mean age was 82.2 + 7.1 years and all were rated high fall risks using the Morse scale.
INTERVENTION Subjects were randomly assigned to the FallSaver device or no device (Observation) for 60 days. Following the end of the 60-day period subjects were crossed over to the opposite treatment. The device, enclosed in an adhesive patch, was applied to the subject’s thigh.
MAIN OUTCOME MEASURE The primary outcome measures were falls and fall-related injuries. Secondary outcomes were falls resulting from documented attempts to stand or ambulate without assistance, skin-tolerance to the patch, and compliance.
RESULTS. Total patient-days for the FallSaver and Observation phases were 1,923 and 2,299, respectively. A total of 37 falls occurred in 18 subjects. Thirteen falls occurred during the FallSaver phase and 24 during Observation (p = < 0.05). A total of 7 fall-related injuries occurred; one during the FallSaver phase and 6 during Observation (p = < 0.01). Nineteen falls resulted from documented attempts to stand or ambulate without assistance, six during the FallSaver phase and 13 during Observation (p = < 0.05). The patch was well tolerated and no serious adverse effects were observed.
CONCLUSION. The FallSaver device reduced the frequency of falls by 50% and fall-related injuries by 82% in elderly at-risk SNF residents. 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00249743
|United States, Washington|
|Spokane Veterans Homes|
|Spokane, Washington, United States, 99202|
|Study Director:||Kathryn E Kelly, DrPH||NOCwatch International, Inc.|
|Principal Investigator:||Dennis Clifton, PharmD||Washington State University|