Predict Near Future Initiation of Bed Exit

NCT01774708 | Terminated DMC

• 3 other identifiers: 1R21EB015943-010664699330000R43AG042237-01
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Presence/absence in bed along with heartbeat, respiration, and gross motion in bed will be measured in 48 Budd Terrace residents, a long-term care facility of Emory Healthcare. Measurement will be done using only pressure-sensitive mats that lie underneath the mattress and never touch the patient. PHI information will be collected by Emory staff. This PHI will be restricted to: age at time of participation; medical conditions; and medications. The PHI will be stored in a locked file behind a locked door. Data management will provide a unique identifier for each participant linked to a name that will be kept separately from the aggregate data. The data collected from the bed sensor will be processed offline and separately from the PHI to do proof of concept evaluation for the use of machine learning technology to predict bed exits 1 to 5 minutes ahead of time.

Conditions

Sleep

Outcome Measures

Primary Outcomes (2)

• Bed Exit

  Measurements on respiratory rate, pulse, bed movement and bed presence will be collected continously during subjects' participation. Data epochs for analysis might be as short as 1 second. Data collection will be done via the pressure-sensitive mats that lie underneath the mattress and never touch the patient. PHI information will be collected and maintained by Emory staff.

  Data collected continuously from monitors for up to 24 weeks will be downloaded to a secure server or flash drive approximately once a week, either wirelessly from outside the room or while the patient is outside the room for other reasons.

• Bed Exit

  A pizo-electric mat will detect the presence or absence of a body in the bed.

  Monitored continuously for up to 24 weeks

Secondary Outcomes (1)

• Movement in bed

  Measured continuously while a patient is in bed for 24 hours per day up to 24 weeks

Study Arms (1)

Bed Exit

Participants will be up to 60 ambulatory Budd Terrace residents. Inclusion/Exclusion: Inclusion: 1. Ambulatory patient able to leave the bed. 2. Willingness to consent and participate in a 30-night study Exclusion: 1. Lack of capacity to consent, without an identifiable surrogate. 2. Terminal Prognosis 3. Unstable health, as determined by the principal investigator, medical doctor, or registered nurse.

Device: Pressure sensitive pad

Interventions

Pressure sensitive pad DEVICE

The proposed research uses an investigational device from EarlySense consisting of a pressure sensitive piezoelectric pad 350 mm x 226 mm x 12 mm or a little less than 9 by 13 inches and under a half inch thick connected to a cord resembling a phone cord to a controller 10.3 by 10.5 by 5.5 inches which in turn plugs into a standard electrical outlet. The power cord is modu¬lar, so it is possible to select a cord that is long enough without having excessive extra length. The con¬nec¬tion between the pad and the monitor has a quick release like a modular telephone. This system is designed to very unobtrusively collect heartbeat patterns, respiratory patterns, motion in bed, and bed-exit data with no risk or inconvenience to the patient.

Also known as: THE EMFIIT MOVEMENT MONITOR

Bed Exit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be up to 60 ambulatory Budd Terrace residents.

You may qualify if:

• Ambulatory patient able to leave the bed.
• Willingness to consent and participate in a 30-night study

You may not qualify if:

• Lack of capacity to consent, without an identifiable surrogate.
• Terminal Prognosis
• Unstable health, as determined by the principal investigator, medical doctor, or registered nurse.

Sponsors & Collaborators

• Atlanta VA Medical Center: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Budd Terrace

Atlanta, Georgia, 30329, United States

Location

Related Publications (2)

• Vandenberg AE, van Beijnum BJ, Overdevest VGP, Capezuti E, Johnson TM 2nd. US and Dutch nurse experiences with fall prevention technology within nursing home environment and workflow: A qualitative study. Geriatr Nurs. 2017 Jul-Aug;38(4):276-282. doi: 10.1016/j.gerinurse.2016.11.005. Epub 2016 Dec 10.

  PMID: 27956058 BACKGROUND

• Johnson TM, Capezuti E, Whalen T, Vandenberg AE, Taylor T, Cohen M. Predicting resident bed exits in long-term care. Journal of the American Geriatrics Society. 2016; 64(S1): S183.

  RESULT

Study Officials

• Thomas Whalen

  CDIC, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Investigator

Study Record Dates

• First Submitted: December 21, 2012
• First Posted: January 24, 2013
• Study Start: December 1, 2012
• Primary Completion: February 28, 2013
• Study Completion: March 1, 2014
• Last Updated: September 16, 2021

Record last verified: 2021-09

Locations

US (1)