NCT03345277

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

1.4 years

First QC Date

November 5, 2017

Last Update Submit

July 1, 2019

Conditions

Keywords

TermperatureFeverVital Signs

Outcome Measures

Primary Outcomes (1)

  • Continuous temperature monitoring

    monitoring temperature wirelessly via Bluetooth thermometer

    90 days duration for study participation

Study Arms (1)

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

Interventions

Residents in a long term care facility will wear a thermometer continuously for 3 months, measuring their body temperature

Continuous Temperature monitoring

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Residents in a long term care facility.

You may qualify if:

  • Residents of a long-term care facility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Avera McKennan Hospital and University Health Center

Sioux Falls, South Dakota, 57117, United States

Location

MeSH Terms

Conditions

Fever

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Vernon Smith, MD

    Avera Health

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2017

First Posted

November 17, 2017

Study Start

December 1, 2017

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

July 5, 2019

Record last verified: 2019-07

Locations