Accidental FallsPhase 1/2NCT00249743
Clinical Evaluation of a Wireless Monitoring Device to Reduce Falls in the Elderly and Others at High Risk of Falling
A Phase 1/2 study testing FallSaver (formerly called NOCwatch) in people with Accidental Falls and Fractures, run by NOCwatch International at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Accidental Falls, Fractures, Injuries
- What is being tested?
- FallSaver (formerly called NOCwatch)
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Jul 2005
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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+).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NIH-NIA SBIR Phase I/II Study: Clinical Evaluation of a Device to Reduce Patient Falls
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.
Read the 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.
- Conditions
- Accidental Falls, Fractures, Injuries
- Being tested
- FallSaver (formerly called NOCwatch)
- Keywords
- fall prevention, fall risk management, RCT, cost
- Medical subject headings
- Fractures, Bone, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FallSaver (formerly called NOCwatch)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Falls and fall-related injuries.
Secondary outcomes (3)
Falls resulting from documented attempts to stand or ambulate without assistance.
Skin tolerance to the adhesive.
Compliance.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2005 (estimated)
- Study startDec 2004
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- NOCwatch International
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Investigators
- Kathryn E Kelly, DrPH, Study director, NOCwatch International, Inc.Dennis Clifton, PharmD, Principal investigator, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00249743
- Sponsor's protocol ID
- 4R44AG022270-02
- Status last verified
- May 2006
- First submitted
- 3 Nov 2005
- Last updated
- 29 May 2006
- Results posted
- No
Publications
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. doi: 10.1097/01.JAM.0000036702.12824.82.
PubMed 12807607
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIH-NIA SBIR Phase I/II Study: Clinical Evaluation of a Device to Reduce Patient Falls
- ClinicalTrials.gov ID
- NCT00249743
- Acronym / sponsor ID
- 4R44AG022270-02
- Conditions
- Accidental Falls, Fractures, Injuries
- Keywords
- fall prevention, fall risk management, RCT, cost
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- NOCwatch InternationalIndustry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- Dec 2004
- Study completion
- Jul 2005
- First posted
- 7 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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+).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FallSaver (formerly called NOCwatch) | Device | – |
Primary outcome
Falls and fall-related injuries.
3 secondary outcomes
Falls resulting from documented attempts to stand or ambulate without assistance.
Skin tolerance to the adhesive.
Compliance.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2006.
- Background: PubMed 12807607Kelly 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. doi: 10.1097/01.JAM.0000036702.12824.82.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn E Kelly, DrPH study director
NOCwatch International, Inc.
Dennis Clifton, PharmD principal investigator
Washington State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing FallSaver (formerly called NOCwatch) in people with Accidental Falls and Fractures, run by NOCwatch International at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Falls and fall-related injuries.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00249743, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2006.