Clinical trial NCT01774708: Predict Near Future Initiation of Bed Exit
Official title: Predict Near Future Initiation of Bed Exit to Prompt Effective Intervention to Avoid Nighttime Falls With Pattern-recognition Algorithms Using Unobtrusive Monitoring of Movement and Vital Signs
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Sleep
Lead sponsor: Atlanta VA Medical Center
Sponsor class: FED
Collaborators: name: National Institute on Aging (NIA)
First posted: 2013-01-24
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be up to 60 ambulatory Budd Terrace residents.

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.

Detailed description: Falls and fall-related injuries are the leading cause of injury deaths among older adults. This proposal will help prevent falls at night by developing a new alarm system. Current bed-exit alarm systems sound when the patient is half way out of the bed or on the ground. We need a warning for when a patient is about to try to exit the bed.

The investigators believe that patients' heart rate or breathing changes before they leave bed. They may also start moving within the bed. This is a brief study with nursing home patient participants. Our primary outcome of interest is bed-exits, and up to 10 participants at a time will be monitored for an average of 6 weeks (less than their anticipated stay) until which time that 250 bed exits have been recorded. Nearly all participants will have physical and/or mental impairments and will be at high risk for falling.

The investigators will use an investigational device to watch over the patient using a pad under the mattress. This monitor is called the "Early-Sense 5". The system works like a microphone for very low sounds. It changes heart, lungs, and movement vibrations into tiny electrical signals. A wire carries these signals to a control box.

The information collected in the box will be stored and checked later. We will use five different math descriptions for recognizing patterns. One or more of these may be useful to give a 1 - 5 minute early warning that the patient is about to exit the bed.

The plan is to determine whether patterns of differences in three areas (heart rate, breathing rate, and body movement) can be recognized and depended on to warn us about bed-exits or attempted bed-exits.

There are four study targets. The first is to develop five possible mathematical descriptions. The second is to use the rest of the information to test which of the descriptions have meaningful ability to predict that a patient is about to get out of bed. The third is to show that warning times are one to five minutes. The fourth is to test the best mathematical descriptions for false alarms and true fall prevention.

How doable Phase I is will depend on how well we can predict that a patient is about to get out of bed. If we can identify a pattern easily, then Phase II research will be put forward.

This study is supported by the National Institute on Aging (SBIR-I).

Eligibility criteria: 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.

Primary outcomes:
measure: Bed Exit
timeFrame: 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.
measure: Bed Exit
timeFrame: Monitored continuously for up to 24 weeks
Secondary outcomes:
measure: Movement in bed
timeFrame: Measured continuously while a patient is in bed for 24 hours per day up to 24 weeks
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Budd Terrace
state: Georgia
Study officials:
affiliation: CDIC, Inc
name: Thomas Whalen
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.