Continuous TemperatureNCT03345277
Continuous Temperature Measurement for Syndromic Surveillance
An observational study of Continuous Temperature and Syndromic Surveillance, run by Avera McKennan Hospital & University Health Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Continuous Temperature, Syndromic Surveillance, Long-term Care
- What is being tested?
- Continuous Temperature monitoring
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2017to 30 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Residents in a long term care facility.
Who may be able to join
- Residents of a long-term care facility
Who cannot join
- Residents who choose not to participate or are determined, by their care providers, to be inappropriate for inclusion.
Trial locations and contacts
1 site in 1 country.
United States1 site
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, 57117
About this study
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.
Read the 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.
- Being tested
- Continuous Temperature monitoring
- Keywords
- Termperature, Fever, Vital Signs
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Temperature monitoringOther
Residents in a long term care facility will wear a thermometer continuously for 3 months, measuring their body temperature
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Continuous Temperature monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous temperature monitoring
monitoring temperature wirelessly via Bluetooth thermometer
Measured: 90 days duration for study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Dec 2017
- Primary completion30 Apr 2019 (estimated)
- Study completion30 Apr 2019 (estimated)
Why it stopped: Study never reached the enrolling phase and PI has since relocated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Continuous TemperatureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avera McKennan Hospital & University Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vernon Smith, MD, Principal investigator, Avera Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03345277
- Sponsor's protocol ID
- AMK-2016.065
- Status last verified
- Jul 2019
- First submitted
- 5 Nov 2017
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Temperature Measurement for Syndromic Surveillance
- ClinicalTrials.gov ID
- NCT03345277
- Acronym / sponsor ID
- AMK-2016.065
- Keywords
- Termperature, Fever, Vital Signs
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study never reached the enrolling phase and PI has since relocated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Avera McKennan Hospital & University Health CenterUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- 30 Apr 2019 (estimated)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Continuous Temperature monitoring | – | Other: Continuous Temperature monitoringAll 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Residents in a long term care facility.
Key inclusion criteria (1 listed)
- Residents of a long-term care facility
Key exclusion criteria (1 listed)
- Residents who choose not to participate or are determined, by their care providers, to be inappropriate for inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Temperature monitoringResidents in a long term care facility will wear a thermometer continuously for 3 months, measuring their body temperature | Other | Continuous Temperature monitoring |
Primary outcome
Continuous temperature monitoring
Time frame: 90 days duration for study participation
monitoring temperature wirelessly via Bluetooth thermometer
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vernon Smith, MD principal investigator
Avera Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Continuous Temperature and Syndromic Surveillance, run by Avera McKennan Hospital & University Health Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous temperature monitoring (time frame: 90 days duration for study participation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.