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

NCT00249743 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2006-05-29

No results posted yet for this study

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.

Conditions

  • Accidental Falls
  • Fractures
  • Injuries

Interventions

DEVICE

FallSaver (formerly called NOCwatch)

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute on Aging (NIA)

    collaborator NIH

  • NOCwatch International

    lead INDUSTRY

Principal Investigators

  • Kathryn E Kelly, DrPH · NOCwatch International, Inc.

  • Dennis Clifton, PharmD · Washington State University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
0 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Completion
2005-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00249743 on ClinicalTrials.gov