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

This study has been completed.
Sponsor:
Collaborators:
Information provided by:
NOCwatch International
ClinicalTrials.gov Identifier:
NCT00249743
First received: November 3, 2005
Last updated: May 25, 2006
Last verified: May 2006
  Purpose

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.


Condition Intervention Phase
Accidental Falls
Fractures
Injuries
Device: FallSaver (formerly called NOCwatch)
Phase 1
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by NOCwatch International:

Primary Outcome Measures:
  • Falls and fall-related injuries.

Secondary Outcome Measures:
  • Falls resulting from documented attempts to stand or ambulate without assistance.
  • Skin tolerance to the adhesive.
  • Compliance.

Estimated Enrollment: 50
Study Start Date: December 2004
Estimated Study Completion Date: July 2005
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 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00249743

Locations
United States, Washington
Spokane Veterans Homes
Spokane, Washington, United States, 99202
Sponsors and Collaborators
NOCwatch International
Investigators
Study Director: Kathryn E Kelly, DrPH NOCwatch International, Inc.
Principal Investigator: Dennis Clifton, PharmD Washington State University
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00249743     History of Changes
Other Study ID Numbers: 4 R44 AG022270-02
Study First Received: November 3, 2005
Last Updated: May 25, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by NOCwatch International:
fall prevention
fall risk management
RCT
cost

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on August 27, 2014