High Risk for FallingNCT03678402
Testing the Effectiveness of a Falls Prevention System
A study testing PUP™ sock in people with High Risk for Falling, run by Tammy Moore at 1 site in United States.
Trial summary
The purpose of this single arm intervention study is to determine if the fall rate (as measured by falls per 1000 patient days) for patients designated "high fall risk" decreases with the use of the PUP™ [Patient is UP Falls Prevention System] when compared to the historical falls rate data for the prior 12 months… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Risk for Falling
- What is being tested?
- PUP™ sock
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 521 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years of age or older;
- All high-risk fall patients, eighteen years of age or older, who are admitted to the OSU Brain and Spine Hospital on Floors 8 South, 9 South, 10 South, 8 East, 9 East or 10 East. Patients will undergo a pre-assessment as per OSUWMC procedure to determine if they are a high-fall risk.
Who cannot join
- Patients whose medical condition as assessed by the PI prohibits their participation in the program, which would include among others the following: patients who lack the capacity to consent, patients with an anatomy or wound issue on their feet or around their calves that would bar them from wearing socks on either foot, and/or patients for whom the sock would impede medical treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
The purpose of this single arm intervention study is to determine if the fall rate (as measured by falls per 1000 patient days) for patients designated "high fall risk" decreases with the use of the PUP™ [Patient is UP Falls Prevention System] when compared to the historical falls rate data for the prior 12 months from those same nursing units within the OSUWM Brain \& Spine Hospital.
Read the detailed description
The purpose of this single arm intervention study is to determine if the fall rate (as measured by falls per 1000 patient days) for patients designated "high fall risk" decreases with the use of the PUP™ [Patient is UP Falls Prevention System] when compared to the historical falls rate data for the prior 12 months from those same nursing units within the OSUWM Brain \& Spine Hospital. All Brain and Spine Hospital patients will be evaluated as to fall risk using the current fall risk assessment tool employed by OSU Medical Center and administered in the usual and customary fashion upon evaluation on the floor and Pod. Patients who are determined to be at a high fall risk will be approached to participate. Those patients who consent to participate in the study will remain in the study until a nurse removes the patient from high risk fall status or the participant has been discharged from the hospital. Any patient fall will to be reported and evaluated following current processes and procedures developed by the OSU Brain and Spine Institute as maintained with IHIS; the PUP™ as the intervention for this study will be an adjunct to those fall prevention processes already in place.
- Conditions
- High Risk for Falling
- Being tested
- PUP™ sock
- Keywords
- falling, inpatient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PUP™ sockDevice
Also called PUP™ (Patient is Up) System
The Palarum Fall Prevention System that includes the PUP™ (Patient is Up) System, is made upon of seven tangible elements: an inpatient room Android tablet (IRT), a nurse station Android monitor (HUC), a local server (PLS), a cloud server (PCS), a Bluetooth Low Energy beacon(s), an Android smart watch, and an e-textile sock connected sensor transmitter (PUP™ sock). The PUP™ sock monitors and transmits pressure, force, acceleration and motion data.
| Study group | Role | What they receive |
|---|---|---|
| Palarum Fall Prevention System | Experimental | The Study site, the OSU Wexner Center Brain and Spine Hospital, is located on three contiguous floors with each floor being made up of two units or Pods designated East and South. Following commencement of the study, and throughout its duration, Pods assigned to the Study will only utilize the Palarum Fall Prevention System and a monitored PUP™ sock, i.e., (Patient is Up) System as the standard of care intervention for fall prevention in accordance with its operating instructions and procedures. Receives: Device: PUP™ sock |
What is being measured
The primary outcome is the main question the study is designed to answer.
High Risk Fall Rate
To determine if the fall rate (as measured by falls per 1000 patient days) for patients designated "high fall risk" decreases with the use of the intervention (Patient is UP fall prevention technology [PUP™ ]) when compared to historical NDNQI data for the prior 12 months ("Benchmark Data") from nursing units where the intervention is being undertaken.
Measured: hospital stay (on average 5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start24 Jun 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for High Risk for FallingStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single arm prospective non-randomized study
- Masking
- None (open label)
- Enrolment
- 521 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tammy Moore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tammy Moore, Ohio State University
- Investigators
- Tammy Moore, RN, PHD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03678402
- Sponsor's protocol ID
- 2018H0303
- Status last verified
- Jul 2024
- First submitted
- 18 Sep 2018
- Last updated
- 12 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD will not be shared outside of the institution. Any data to be shared will have been deidentified.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effectiveness of a Falls Prevention System
- ClinicalTrials.gov ID
- NCT03678402
- Acronym / sponsor ID
- 2018H0303
- Conditions
- High Risk for Falling
- Keywords
- falling, inpatient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 521 participants (actual)
- Lead sponsor
- Tammy MooreUniversity, hospital or other
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 19 Sep 2018 (actual)
- Results
- Posted 4 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this single arm intervention study is to determine if the fall rate (as measured by falls per 1000 patient days) for patients designated "high fall risk" decreases with the use of the PUP™ [Patient is UP Falls Prevention System] when compared to the historical falls rate data for the prior 12 months from those same nursing units within the OSUWM Brain \& Spine Hospital.
Detailed description
The purpose of this single arm intervention study is to determine if the fall rate (as measured by falls per 1000 patient days) for patients designated "high fall risk" decreases with the use of the PUP™ [Patient is UP Falls Prevention System] when compared to the historical falls rate data for the prior 12 months from those same nursing units within the OSUWM Brain \& Spine Hospital. All Brain and Spine Hospital patients will be evaluated as to fall risk using the current fall risk assessment tool employed by OSU Medical Center and administered in the usual and customary fashion upon evaluation on the floor and Pod. Patients who are determined to be at a high fall risk will be approached to participate. Those patients who consent to participate in the study will remain in the study until a nurse removes the patient from high risk fall status or the participant has been discharged from the hospital. Any patient fall will to be reported and evaluated following current processes and procedures developed by the OSU Brain and Spine Institute as maintained with IHIS; the PUP™ as the intervention for this study will be an adjunct to those fall prevention processes already in place.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single arm prospective non-randomized study
| Arm | Type | Receives |
|---|---|---|
| Palarum Fall Prevention System | Experimental | Device: PUP™ sockThe Study site, the OSU Wexner Center Brain and Spine Hospital, is located on three contiguous floors with each floor being made up of two units or Pods designated East and South. Following commencement of the study, and throughout its duration, Pods assigned to the Study will only utilize the Palarum Fall Prevention System and a monitored PUP™ sock, i.e., (Patient is Up) System as the standard of care intervention for fall prevention in accordance with its operating instructions and procedures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 years of age or older;
- All high-risk fall patients, eighteen years of age or older, who are admitted to the OSU Brain and Spine Hospital on Floors 8 South, 9 South, 10 South, 8 East, 9 East or 10 East. Patients will undergo a pre-assessment as per OSUWMC procedure to determine if they are a high-fall risk.
Key exclusion criteria (1 listed)
- Patients whose medical condition as assessed by the PI prohibits their participation in the program, which would include among others the following: patients who lack the capacity to consent, patients with an anatomy or wound issue on their feet or around their calves that would bar them from wearing socks on either foot, and/or patients for whom the sock would impede medical treatment.
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 |
|---|---|---|
| PUP™ sockAlso: PUP™ (Patient is Up) SystemThe Palarum Fall Prevention System that includes the PUP™ (Patient is Up) System, is made upon of seven tangible elements: an inpatient room Android tablet (IRT), a nurse station Android monitor (HUC), a local server (PLS), a cloud server (PCS), a Bluetooth Low Energy beacon(s), an Android smart watch, and an e-textile sock connected sensor transmitter (PUP™ sock). The PUP™ sock monitors and transmits pressure, force, acceleration and motion data. | Device | Palarum Fall Prevention System |
Primary outcome
High Risk Fall Rate
Time frame: hospital stay (on average 5 days)
To determine if the fall rate (as measured by falls per 1000 patient days) for patients designated "high fall risk" decreases with the use of the intervention (Patient is UP fall prevention technology [PUP™ ]) when compared to historical NDNQI data for the prior 12 months ("Benchmark Data") from nursing units where the intervention is being undertaken.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. IPD will not be shared outside of the institution. Any data to be shared will have been deidentified.
Related trials for High Risk for Falling
Not yet recruiting
Backward Walking Rehabilitation to Prevent Falls in High-risk Adults Aged 75 Years and Older
High Risk of Falling
Not yet recruiting
Monitoring Combined Effect of Balance and Strengthening Exercises on Static and Dynamic Balance in Elderly Populations
Geriatrics Balance Disturbance With High Risk Falling, Osteoporosis, Vestibular Age Related Changes, Female Post-menopausal Based on History
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.
Tammy Moore, RN, PHD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PUP™ sock in people with High Risk for Falling, run by Tammy Moore 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 2 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 12 Jul 2024. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
High Risk Fall Rate (time frame: hospital stay (on average 5 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jul 2024; AzTrials last refreshed its copy on 30 Oct 2026.