Continuous Temperature Measurement for Syndromic Surveillance

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.

Study Overview

• Status: Withdrawn
• Conditions: Continuous Temperature; Syndromic Surveillance; Long-term Care
• Intervention / Treatment: Other: Continuous Temperature monitoring

Detailed 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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57117
      • Avera McKennan Hospital and University Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Residents in a long term care facility.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continuous temperature monitoring	monitoring temperature wirelessly via Bluetooth thermometer	90 days duration for study participation

Collaborators and Investigators

• Sponsor: Avera McKennan Hospital & University Health Center
• Investigators: Principal Investigator: Vernon Smith, MD, Avera Health

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Anticipated): April 30, 2019
• Study Completion (Anticipated): April 30, 2019

Study Registration Dates

• First Submitted: November 5, 2017
• First Submitted That Met QC Criteria: November 15, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 1, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Fever; Vital Signs; Termperature
• Other Study ID Numbers: AMK-2016.065

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No