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Accidental Fall From BedPhase 2NCT03003663

Interrupted Time-Series Study for In-hospital Fall Reduction

A Phase 2 study testing SensableCare System in people with Accidental Fall From Bed and Patient Fall, run by MedicusTek, Inc at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the effect of an Internet-of-Things bed fall solution when used in a hospital setting. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Accidental Fall From Bed, Patient Fall
What is being tested?
SensableCare System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
658 participants
Where
1 siteTaiwan
Study dates
Mar 2016to 6 Dec 2017
Phase
Phase 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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • inpatient
  • consents to study (family members may sign on behalf of patients unable to consent)
  • high fall risk patient (assessed fall risk score greater than or equal to 3 points

Who cannot join

  • unable to cooperate
  • under quarantine
  • using special mattresses (cushion pad, air mattresses)

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei, Pei-Tou District

Other trials in Taiwan

About this study

The purpose of this study is to determine the effect of an Internet-of-Things bed fall solution when used in a hospital setting.

Read the detailed description

The purpose of this study is to determine the effect of an Internet-of-Things bed fall solution when used in a hospital setting.

The study evaluates the SensableCare System for reducing bed falls. The SensableCare System will be used in three units of a hospital. It will be turned off for one month for the control group and then turned on the next month for the intervention group, repeating this sequence until the study concludes. To better inform the data analysis, the investigators collect baseline patient characteristics, fall risk scores, and the unit fall rate every month.

The SenableCare System: A pressure sensor pad is placed between the mattress surface and the bed sheet. The system lets nurses know how the patient is positioned in bed at the time of the alert, from which room number the alert is being generated, and informs other nurses when a patient is being assisted.

Using a predictive algorithm, the system can also monitor patient position in bed and send specific, customized alerts if nurses want to know when a patient begins to stir in bed, sits up in bed, attempts to leave the bed, or is already out of bed. When the system's software algorithm detects an increased probability of a bed exit, the system alerts the nursing staff via an app on mobile devices (i.e., smartphones) that nurses carry and via a dashboard at the nursing station. When the patient attempts to leave the bed, an audible message coming from a control box next to the patient's bed reminds the patient not to leave and that a nurse will arrive shortly. Concurrently, nurses receive alerts at a dashboard and through their smartphones via audible, vibratory, and visual alerts prompting a rapid response. Nurses respond to the alerts by tapping a control box in the patient room or returning the patient back to bed; this turns off alerts at the dashboard and on other nurses' smartphones.

Nurses can customize each individual patient's alert settings. Nurses receive bed leaving alerts when the System detects the patient is attempting to leave the bed or is out of the bed. Nurses may also choose to receive alerts when a patient is stirring after being still for >20 minutes and/or when a patient is sitting up in bed. Both the nurse and nurse aide responsible for an enrolled patient receive alerts directly through their smartphones via a real-time push notification. The charge nurse at the nursing station also receives alerts through the SensableCare app on the dashboard.

Standard medical care: A standard bed fall alarm or no alarm is used as standard medical care. The three trial units only have two bed fall alarms available for high fall risk patients. Those who do not consent to the study use this standard bed fall alarm or none at all. The standard bed fall alarm signals when a patient is exiting the bed via an audible alert. The nurses listen for the sound and go to the room to assist the patient.

Being tested
SensableCare System
Keywords
Fall Prevention, Interrupted Time-Series Study, Patient Safety, Patient-Centered Care, Patient Monitoring, Health Care Technology, Mobile Applications, Bedside Monitor, Mechanical Fall

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SensableCare SystemDevice

    The SensableCare System is evaluated for reducing bed falls.

Study groups in NCT03003663
Study groupRoleWhat they receive
SensableCare SystemExperimentalDevice:The interrupted time series design will alternate between the following on a monthly basis: (1) standard medical care and (2) standard medical care and the SensableCare System.
Receives: Device: SensableCare System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fall Rate

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2016 (estimated)
  2. Study startMar 2016
  3. Primary completion6 Jun 2017
  4. Study completion6 Dec 2017

Resources

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 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
658 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03003663
Sponsor's protocol ID
20150701A
Status last verified
Feb 2018
First submitted
12 Dec 2016
Last updated
23 Feb 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SensableCare System in people with Accidental Fall From Bed and Patient Fall, run by MedicusTek, Inc at 1 site in Taiwan.

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 3 inclusion and 3 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 23 Feb 2018. 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 Taiwan. 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 phase mean?

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?

Fall Rate (time frame: 18 months). 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 23 Feb 2018.

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