Continuous Temperature Measurement for Syndromic Surveillance

Long-term Care Clinical Trial

Official title:

Continuous Temperature Measurement for Syndromic Surveillance

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03345277
• Other study ID #: AMK-2016.065
• Status: Withdrawn
• Start date: December 1, 2017
• Est. completion date: April 30, 2019

Study information

• Verified date: July 2019
• Source: Avera McKennan Hospital & University Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Continuous Temperature
• Long-term Care
• Syndromic Surveillance

Intervention

Other:
• Continuous Temperature monitoring
Residents in a long term care facility will wear a thermometer continuously for 3 months, measuring their body temperature

Locations

Country	Name	City	State
United States	Avera McKennan Hospital and University Health Center	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Avera McKennan Hospital & University Health Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continuous temperature monitoring	monitoring temperature wirelessly via Bluetooth thermometer	90 days duration for study participation