Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00249743
Status:
COMPLETED
Last Update Posted:
2006-05-29
First Post:
2005-11-03
Brief Title:
Clinical Evaluation of a Wireless Monitoring Device to Reduce Falls in the Elderly and Others at High Risk of Falling
Sponsor:
NOCwatch International
Organization:
NOCwatch International
Study Overview
Official Title:
NIH-NIA SBIR Phase III Study Clinical Evaluation of a Device to Reduce Patient Falls
Status:
COMPLETED
Status Verified Date:
2006-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 4222 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
Detailed Description:
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 822 71 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 subjects 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 1923 and 2299 respectively A total of 37 falls occurred in 18 subjects Thirteen falls occurred during the FallSaver phase and 24 during Observation p 005 A total of 7 fall-related injuries occurred one during the FallSaver phase and 6 during Observation p 001 Nineteen falls resulted from documented attempts to stand or ambulate without assistance six during the FallSaver phase and 13 during Observation p 005 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
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 822 71 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 subjects 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 1923 and 2299 respectively A total of 37 falls occurred in 18 subjects Thirteen falls occurred during the FallSaver phase and 24 during Observation p 005 A total of 7 fall-related injuries occurred one during the FallSaver phase and 6 during Observation p 001 Nineteen falls resulted from documented attempts to stand or ambulate without assistance six during the FallSaver phase and 13 during Observation p 005 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None