Clinical Evaluation of a Wireless Monitoring Device to Reduce Falls in the Elderly and Others at High Risk of Falling

Accidental Falls Clinical Trial

Official title:

NIH-NIA SBIR Phase I/II Study: Clinical Evaluation of a Device to Reduce Patient Falls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00249743
• Other study ID #: 4R44AG022270-02
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 3, 2005
• Last updated: May 25, 2006
• Start date: December 2004
• Est. completion date: July 2005

Study information

• Verified date: May 2006
• Source: NOCwatch International
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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+).

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Accidental Falls
• Fractures
• Injuries

Intervention

Device:
• FallSaver (formerly called NOCwatch)

Locations

Country	Name	City	State
United States	Spokane Veterans Homes	Spokane	Washington

Sponsors (3)

Lead Sponsor	Collaborator
NOCwatch International	National Institute on Aging (NIA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kelly KE, Phillips CL, Cain KC, Polissar NL, Kelly PB. Evaluation of a nonintrusive monitor to reduce falls in nursing home patients. J Am Med Dir Assoc. 2002 Nov-Dec;3(6):377-82. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Falls and fall-related injuries.
Secondary	Falls resulting from documented attempts to stand or ambulate without assistance.
Secondary	Skin tolerance to the adhesive.
Secondary	Compliance.