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.
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.
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.
- Conditions
- Accidental Fall From Bed, Patient Fall
- 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 group | Role | What they receive |
|---|---|---|
| SensableCare System | Experimental | Device: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.
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.
- First posted28 Dec 2016 (estimated)
- Study startMar 2016
- Primary completion6 Jun 2017
- Study completion6 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental Fall From BedStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 658 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedicusTek, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ging-Long Wang, MD, MPH, Principal investigator, Koo Foundation Sun Yat-Sen Cancer Center
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interrupted Time-Series Study for In-hospital Fall Reduction
- ClinicalTrials.gov ID
- NCT03003663
- Acronym / sponsor ID
- 20150701A
- Conditions
- Accidental Fall From Bed, Patient Fall
- Keywords
- Fall Prevention, Interrupted Time-Series Study, Patient Safety, Patient-Centered Care, Patient Monitoring, Health Care Technology, Mobile Applications, Bedside Monitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 658 participants (actual)
- Lead sponsor
- MedicusTek, IncIndustry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- 6 Jun 2017 (actual)
- Study completion
- 6 Dec 2017 (actual)
- First posted
- 28 Dec 2016 (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.
The purpose of this study is to determine the effect of an Internet-of-Things bed fall solution when used in a hospital setting.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SensableCare System | Experimental | Device: SensableCare SystemDevice: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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- unable to cooperate
- under quarantine
- using special mattresses (cushion pad, air mattresses)
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 |
|---|---|---|
| SensableCare SystemThe SensableCare System is evaluated for reducing bed falls. | Device | SensableCare System |
Primary outcome
Fall Rate
Time frame: 18 months
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 23 Feb 2018.
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.
Ging-Long Wang, MD, MPH principal investigator
Koo Foundation Sun Yat-Sen Cancer Center
1 site in 1 country: see every site and its status.
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.