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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Recruitment Status : Withdrawn (Study never reached the enrolling phase and PI has since relocated)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
Sponsor:
Information provided by (Responsible Party):
Avera McKennan Hospital & University Health Center

Brief 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.

Condition or disease Intervention/treatment
Continuous Temperature Syndromic Surveillance Long-term Care 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.


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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

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




Primary Outcome Measures :
  1. Continuous temperature monitoring [ Time Frame: 90 days duration for study participation ]
    monitoring temperature wirelessly via Bluetooth thermometer



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Residents in a long term care facility.
Criteria

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.

Information from the National Library of Medicine

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


Locations
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United States, South Dakota
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, United States, 57117
Sponsors and Collaborators
Avera McKennan Hospital & University Health Center
Investigators
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Principal Investigator: Vernon Smith, MD Avera Health

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Responsible Party: Avera McKennan Hospital & University Health Center
ClinicalTrials.gov Identifier: NCT03345277     History of Changes
Other Study ID Numbers: AMK-2016.065
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Avera McKennan Hospital & University Health Center:
Termperature
Fever
Vital Signs