Fall From BedEarly Phase 1NCT03876496
Sensable®Care System: Establishing a Communications System for Patient Fall Reduction
A Early Phase 1 study testing SensableCare System in people with Fall From Bed, run by MedicusTek USA Corporation at 1 site in United States.
Trial summary
The purpose of this study is to test the effectiveness, safety and side effects of Sensable®Care System for inpatients. The Sensable®Care System uses pressure sensors and computer software to sense how patients are positioned on the bed in order to reduce bed falls. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fall From Bed
- 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
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2017to 7 Dec 2017
- Phase
- Early Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gender: male or female
- Age: 18 years and older
- Racial and ethnic origin: all ethnic groups
- Hospital status: admitted in-patient or a patient under observation
- Expected hospital length of stay: minimum of 23 hours
- Willingness to participate in the study
- Moderate to High fall risk scoring a 2 or greater on the Mobility or Mental/LOC/Awareness status sections of the Hester Davis Fall Risk Assessment.
Who cannot join
- Declined to participate
- Patients less than 18 years old
- Patients who have been identified as a low fall risk or moderate fall risk with score less than 2 on the Mobility or Mental/ LOC/Awareness status sections of the Hester Davis Fall Risk Assessment
- Women who are documented as pregnant during the study period
- Patients who are medically unstable; as per the discretion of the primary nurse
- Patients who are actively in the dying process, at the discretion of the primary nurse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase One Feasibility Study of the Sensable®Care System: Establishing a Communications System for Patient Fall Reduction
The purpose of this study is to test the effectiveness, safety and side effects of Sensable®Care System for inpatients. The Sensable®Care System uses pressure sensors and computer software to sense how patients are positioned on the bed in order to reduce bed falls. The Sensable®Care System Mattress has sensors embedded in them, which will be monitored by the nurses in your unit.
This study has three specific aims:
- To assess the comfort of the system when used with hospitalized patients;
- To observe how the system can be integrated into nurses' and hospital staff's regular workflow to help to modify and improve the system.
- To analyze data from nursing response to alerts generated from hospitalized patients to improve alert system performance.
- Conditions
- Fall From Bed
- Being tested
- SensableCare System
- Keywords
- fall prevention, bed fall, acute care, patient safety, patient monitoring, health technology assessment, sensor devices and platforms, nursing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SensableCare SystemDevice
Also called MedicusTek
The Sensable®Care Mattress has sensors embedded in it. Sensable®Care System is able to identify if the subject is stirring in bed, sitting up from the bed, attempting to leave the bed, or being out of the bed. If the subject is found to be in any of these four scenarios, four different types of alerts/notifications will warn clinicians: Stirring Notification, Sitting Up Notification, Bed Leaving Alert, Out of Bed Alert, will be generated by Sensable®Care System respectively.
Once these four alerts/notifications are generated, designated attending nurses or caregivers equipped with a mobile app will receive audible, vibratory, and/or visual alerts from the Dashboard with subject's room number and type of alert displayed mobile app. Thus, interventions/assistance can be carried out presumably early. Harm to patient safety may be prevented.
| Study group | Role | What they receive |
|---|---|---|
| SensableCareCare System | Experimental | The Sensable®Care System uses pressure sensors and computer software to sense how patients are positioned on the bed in order to reduce bed falls. The Sensable®Care System Mattress has sensors embedded in them, which will be monitored by the nurses in the unit. Receives: Device: SensableCare System |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of Nursing Staff Who Want to Use the System Following the Trial
Acceptance of SensableCare System after Trial Period
Measured: focus group at week 8 within the 13 week study period
% of Nursing Staff Who Want to Use the System Following the Trial
Acceptance of SensableCare System after Trial Period
Measured: focus group at week 12 within the 13 week study period
Secondary outcomes (1)
Rate of Bed Falls Decreased Over Study Period
Whether bed falls had decreased over the study period compared to before the start of the trial
Measured: through the 13 week study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start24 Sep 2017
- Primary completion21 Oct 2017
- Study completion7 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedicusTek USA Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kaiser Permanente
- Responsible party
- Sponsor
- Investigators
- Jerry Spicer, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876496
- Sponsor's protocol ID
- Kaiser Downey CTA
- Status last verified
- Mar 2019
- First submitted
- 22 Aug 2018
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase One Feasibility Study of the Sensable®Care System: Establishing a Communications System for Patient Fall Reduction
- ClinicalTrials.gov ID
- NCT03876496
- Acronym / sponsor ID
- Kaiser Downey CTA
- Conditions
- Fall From Bed
- Keywords
- fall prevention, bed fall, acute care, patient safety, patient monitoring, health technology assessment, sensor devices and platforms, nursing
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- MedicusTek USA CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Kaiser Permanente
- Study start
- 24 Sep 2017 (actual)
- Primary completion
- 21 Oct 2017 (actual)
- Study completion
- 7 Dec 2017 (actual)
- First posted
- 15 Mar 2019 (actual)
- 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 test the effectiveness, safety and side effects of Sensable®Care System for inpatients. The Sensable®Care System uses pressure sensors and computer software to sense how patients are positioned on the bed in order to reduce bed falls. The Sensable®Care System Mattress has sensors embedded in them, which will be monitored by the nurses in your unit.
This study has three specific aims:
- To assess the comfort of the system when used with hospitalized patients;
- To observe how the system can be integrated into nurses' and hospital staff's regular workflow to help to modify and improve the system.
- To analyze data from nursing response to alerts generated from hospitalized patients to improve alert system performance.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SensableCareCare System | Experimental | Device: SensableCare SystemThe Sensable®Care System uses pressure sensors and computer software to sense how patients are positioned on the bed in order to reduce bed falls. The Sensable®Care System Mattress has sensors embedded in them, which will be monitored by the nurses in the unit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Gender: male or female
- Age: 18 years and older
- Racial and ethnic origin: all ethnic groups
- Hospital status: admitted in-patient or a patient under observation
- Expected hospital length of stay: minimum of 23 hours
Key exclusion criteria (6 listed)
- Declined to participate
- Patients less than 18 years old
- Patients who have been identified as a low fall risk or moderate fall risk with score less than 2 on the Mobility or Mental/ LOC/Awareness status sections of the Hester Davis Fall Risk Assessment
- Women who are documented as pregnant during the study period
- Patients who are medically unstable; as per the discretion of the primary nurse
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 SystemAlso: MedicusTekThe Sensable®Care Mattress has sensors embedded in it. Sensable®Care System is able to identify if the subject is stirring in bed, sitting up from the bed, attempting to leave the bed, or being out of the bed. If the subject is found to be in any of these four scenarios, four different types of alerts/notifications will warn clinicians: Stirring Notification, Sitting Up Notification, Bed Leaving Alert, Out of Bed Alert, will be generated by Sensable®Care System respectively. Once these four alerts/notifications are generated, designated attending nurses or caregivers equipped with a mobile app will receive audible, vibratory, and/or visual alerts from the Dashboard with subject's room number and type of alert displayed mobile app. Thus, interventions/assistance can be carried out presumably early. Harm to patient safety may be prevented. | Device | SensableCareCare System |
Primary outcome
% of Nursing Staff Who Want to Use the System Following the Trial
Time frame: focus group at week 8 within the 13 week study period
Acceptance of SensableCare System after Trial Period
% of Nursing Staff Who Want to Use the System Following the Trial
Time frame: focus group at week 12 within the 13 week study period
Acceptance of SensableCare System after Trial Period
1 secondary outcome
Rate of Bed Falls Decreased Over Study Period
Time frame: through the 13 week study period
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 15 Mar 2019.
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.
Jerry Spicer principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing SensableCare System in people with Fall From Bed, run by MedicusTek USA Corporation 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 7 inclusion and 6 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 15 Mar 2019. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
% of Nursing Staff Who Want to Use the System Following the Trial (time frame: focus group at week 8 within the 13 week study period). The study lists 2 primary outcomes in all. 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 15 Mar 2019.