Continuous Temperature Measurement for Syndromic Surveillance



Status:Enrolling by invitation
Healthy:No
Age Range:Any
Updated:10/4/2018
Start Date:December 1, 2017
End Date:April 30, 2019

Use our guide to learn which trials are right for you!

Is it possible to detect infection before it is clinically apparent? Fever is one indicator
of infection. However, until recently, continuous temperature monitoring has not been
feasible. With the advent of microelectronics, long battery life, and wireless transmission,
it is now possible to continuously measure, record and report body temperature. For a period
of 90 days, residents of a long-term care facility will have their body temperature monitored
and then those measurements will then be compared against other available healthcare data
such as other recorded vital signs, nursing notes, provider visits, antibiotics, and
hospitalization records for correlation of underlying infection.

Over 1.5 million people live in 16,000 nursing homes (NH) in the USA and experience an
average of 2 million infections a year. It is well known that NH residents are at risk of
infection because of frequent hospital stays, advanced age, exposure to multiple courses of
antibiotics, numerous comorbidities, diminished immune response, malnutrition, and cognitive
impairment. The most common are pneumonia, UTIs, diarrheal illnesses, and skin and soft
tissue infections. Infections in NH residents have been associated with adverse clinical
outcomes, including high rates of morbidity and mortality, re-hospitalization, prolonged
hospital stays and substantial healthcare expenses.

The identification of fever is a key component in the detection of infections. Studies have
shown that standard definition for fever, 100.5 degrees F, is not sensitive to identify
infections in elderly populations. The recommendation therefore is a fever of 99 degrees F or
an increase of 2.4 degrees F from baseline. These changes in temperatures are also a
significant indication that infection is present.

The collection of episodic temperatures in nursing home residents is challenging. The
collection of baseline measurements for all residents is logistically unachievable. The
continuous measurement of body temperature in any mobile population would be nearly
impossible by any clinically standard means.

With the advent of microelectronics, long battery life, and wireless transmission, it is now
possible to continuously measure, record and report body temperature.

What remains unknown is the feasibility and clinical utility of obtaining these measurements.

Therefore it is proposed that for a period of three months, residents of a single, long-term
care facility have a wearable, thermometer applied to their skin. The medical-grade adhesive
and thermometer will be changed every 2-3 days. The thermometer will provide continuous
temperature measurement that will be sent wirelessly via Bluetooth to access points
positioned throughout the facility.

The temperatures are reported wirelessly every minute and stored in a secure server. All
participants and care providers are blinded to the temperature readings.

At the conclusion of the monitoring period, the temperature readings will be compared to the
longitudinal healthcare record for each of the participants. Particular attention will be
toward hospitalizations, antibiotics, nursing records, and clinic visits to determine
episodes of infectious illness.

Inclusion Criteria:

- Residents of a long-term care facility

Exclusion Criteria:

- Residents who choose not to participate or are determined, by their care providers, to
be inappropriate for inclusion.
We found this trial at
1
site
?
mi
from
Sioux Falls, SD
Click here to add this to my saved trials