Quantifying and Understanding the Signs and Symptoms of Fever

October 5, 2017 updated by: National Institutes of Health Clinical Center (CC)

Beyond Intuition: Quantifying and Understanding the Signs and Symptoms of Fever

Background:

- Fever is a common symptom of illness, but it can involve many signs (a signal that something is not right in the body that can be seen by others, such as vomiting) and symptoms (a signal that something is not right in the body that are felt only by the person, such as pain) that may differ depending on the type of illness involved. Researchers are interested in studying individuals who have a fever to examine how often these signs and symptoms are experienced by patients.

Objectives:

- To identify and evaluate the signs and symptoms of fever and examine their frequency in individuals who have fever.

Eligibility:

- Individuals at least 8 years of age who are admitted to the NIH Clinical Center and have a fever (body temperature of at least 38 degrees Celsius/100.4 degrees Fahrenheit).

Design:

  • Participants will be screened upon admission to the NIH Clinical Center.
  • Researchers will review the Clinical Center admission records.
  • Participants will complete a 15- to 20-minute survey with questions about how they are feeling and what symptoms they have experienced before, during and after an episode of fever.

Study Overview

Status

Terminated

Conditions

Detailed Description

Background:

Fever is one of the most prevalent signs in hospitalized patients, signaling the activation of the immune system.

There is little empiric evidence related to symptoms or signs that accompany changes in body temperature.

Understanding the nature, timing and relationship of patient signs and symptoms of fever will provide insight into the febrile process and guide more informed treatment.

Objectives:

The protocol is divided into two phases:

Phase I

-To develop and implement a simple clinical tool for assessing and documenting patient-reported signs and symptoms of fever.

Phase II

-To describe the prevalence and relationship of signs and symptoms that accompanies a febrile state and related patterns of change over time.

Eligibility:

Phase I

  • Adult and pediatric medical-surgical patients hospitalized at the Clinical Center admitted to 3NE (oncology/ transplant), 3NW (surgical oncology) and 1NW (pediatric).
  • Age greater than or equal to 8 years old
  • Understand and speak English

Phase II

  • Inpatients admitted to the Clinical Research Center
  • Age greater than or equal to 8 years old.

Design:

Phase I

-Descriptive study involving qualitative interviews and chart reviews from medical surgical inpatients. Two types of interviews with two different sets of patients will be conducted. The maximum number of research participants for this phase will be 65. The final sample size will be determined based on the point of saturation, defined as four consecutive interviews during which no new signs or symptoms associated with fever are identified. The second set of interviews will involve 20 to 30 new research participants, including at least 5 patients less than 18 years of age who will review a list of signs and symptoms of fever for comprehension and clarity to inform the final list and determine the terminology to be used in the FAST.

Study of the Febrile Assessment Tool (FAST)

-Test of the FAST in 120 patients. Before placing the FAST in the electronic record (Clinical Research Information System-CRIS) this new assessment tool will be used in approximately 120 patients during routine vital sign measurements. Patients admitted to the surgical oncology unit (3NW) will be consented and followed with collection of the FAST assessments

Education Implementation

  • Inform nursing staff of the background, content and procedures for using the Febrile Assessment Tool (FAST)
  • Educational interim will last 4 weeks

Phase II

  • Approximately 2 months or at the discretion of the PI after FAST education
  • Descriptive study involving chart review from unidentified inpatients. The sample size will be a maximum of 500.

Study Type

Observational

Enrollment (Actual)

99

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • INCLUSION CRITERIA PHASE I:

Adult and pediatric medical-surgical patients hospitalized in the Clinical Center, NIH admitted to 3NE (oncology/ transplant), 3NW (surgical oncology) and 1NW (pediatrics).

Oriented to person, time and place at time of interview

Active fever (body temperature greater than or equal to 38.0 Celsius), treated or untreated, within the last 12 hours.

Willingness to participate in a short interview (15-20 minutes) about their symptoms

Understands and speaks English

Age 8 years and older

INCLUSION CRITERIA FOR STUDY OF FEBRILE ASSESSMENT TOOL:

Adult (18 years of age or greater) medical-surgical patients hospitalized at the Clinical Center and admitted to 3NW.

Oriented to person, time and place at time of admission

Willingness to be asked about their symptoms of fever during vital signs assessment

Understands and speaks English

INCLUSION CRITERIA PHASE II:

Inpatients admitted to the Clinical Center

Age 8 years and older

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Symptoms of fever
Time Frame: Throughout in patient admission
Throughout in patient admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institutes of Health Clinical Center (CC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 13, 2011

Study Completion

August 9, 2017

Study Registration Dates

First Submitted

January 29, 2011

First Submitted That Met QC Criteria

January 29, 2011

First Posted (Estimate)

February 1, 2011

Study Record Updates

Last Update Posted (Actual)

October 6, 2017

Last Update Submitted That Met QC Criteria

October 5, 2017

Last Verified

August 9, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 110083
  • 11-CC-0083

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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