Continuous Temperature Measurement for Syndromic Surveillance
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|ClinicalTrials.gov Identifier: NCT03345277|
Recruitment Status : Withdrawn (Study never reached the enrolling phase and PI has since relocated)
First Posted : November 17, 2017
Last Update Posted : July 3, 2019
|Condition or disease||Intervention/treatment|
|Continuous Temperature Syndromic Surveillance Long-term Care||Other: Continuous Temperature monitoring|
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.
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Continuous Temperature Measurement for Syndromic Surveillance|
|Actual Study Start Date :||December 1, 2017|
|Estimated Primary Completion Date :||April 30, 2019|
|Estimated Study Completion Date :||April 30, 2019|
Continuous Temperature monitoring
All residents of a long-term care facility will be considered for the study over the predetermined timeframe. Residents who choose not to participate or are determined, by their care providers, to be inappropriate for inclusion will be excluded.
Other: Continuous Temperature monitoring
Residents in a long term care facility will wear a thermometer continuously for 3 months, measuring their body temperature
- Continuous temperature monitoring [ Time Frame: 90 days duration for study participation ]monitoring temperature wirelessly via Bluetooth thermometer
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03345277
|United States, South Dakota|
|Avera McKennan Hospital and University Health Center|
|Sioux Falls, South Dakota, United States, 57117|
|Principal Investigator:||Vernon Smith, MD||Avera Health|