FeverNCT01287143
Quantifying and Understanding the Signs and Symptoms of Fever
An observational study of Fever, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Fever
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2011to 9 Aug 2017
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
- Inpatients admitted to the Clinical Center
- Age 8 years and older
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Fever
- Keywords
- Fever, Signs and Symptoms, Febrile Assessment Tool (FAST)
- Medical subject headings
- Fever, Signs and Symptoms
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms of fever
Measured: Throughout in patient admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2011 (estimated)
- Study start13 Jan 2011
- Study completion9 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for FeverStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Nancy Ames, R.N., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01287143
- Sponsor's protocol ID
- 110083
- Other IDs
- 11-CC-0083
- Status last verified
- 9 Aug 2017
- First submitted
- 29 Jan 2011
- Last updated
- 6 Oct 2017
- Results posted
- No
Publications
Laupland KB. Fever in the critically ill medical patient. Crit Care Med. 2009 Jul;37(7 Suppl):S273-8. doi: 10.1097/CCM.0b013e3181aa6117.
PubMed 19535958Chesnutt BK, Zamora MR, Kleinpell RM. Blood cultures for febrile patients in the acute care setting: too quick on the draw? J Am Acad Nurse Pract. 2008 Nov;20(11):539-46. doi: 10.1111/j.1745-7599.2008.00356.x.
PubMed 19128337Bor DH, Makadon HJ, Friedland G, Dasse P, Komaroff AL, Aronson MD. Fever in hospitalized medical patients: characteristics and significance. J Gen Intern Med. 1988 Mar-Apr;3(2):119-25. doi: 10.1007/BF02596115.
PubMed 3357068Ames NJ, Powers JH, Ranucci A, Gartrell K, Yang L, VanRaden M, Leidy NK, Wallen GR. A systematic approach for studying the signs and symptoms of fever in adult patients: the fever assessment tool (FAST). Health Qual Life Outcomes. 2017 Apr 27;15(1):84. doi: 10.1186/s12955-017-0644-6.
PubMed 28449675
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beyond Intuition: Quantifying and Understanding the Signs and Symptoms of Fever
- ClinicalTrials.gov ID
- NCT01287143
- Acronym / sponsor ID
- 110083
- Conditions
- Fever
- Keywords
- Fever, Signs and Symptoms, Febrile Assessment Tool (FAST)
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 99 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 13 Jan 2011
- Study completion
- 9 Aug 2017
- First posted
- 1 Feb 2011 (estimated)
- 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.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Symptoms of fever
Time frame: Throughout in patient admission
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Background: PubMed 19535958Laupland KB. Fever in the critically ill medical patient. Crit Care Med. 2009 Jul;37(7 Suppl):S273-8. doi: 10.1097/CCM.0b013e3181aa6117.
- Background: PubMed 19128337Chesnutt BK, Zamora MR, Kleinpell RM. Blood cultures for febrile patients in the acute care setting: too quick on the draw? J Am Acad Nurse Pract. 2008 Nov;20(11):539-46. doi: 10.1111/j.1745-7599.2008.00356.x.
- Background: PubMed 3357068Bor DH, Makadon HJ, Friedland G, Dasse P, Komaroff AL, Aronson MD. Fever in hospitalized medical patients: characteristics and significance. J Gen Intern Med. 1988 Mar-Apr;3(2):119-25. doi: 10.1007/BF02596115.
- Derived from this study: PubMed 28449675Ames NJ, Powers JH, Ranucci A, Gartrell K, Yang L, VanRaden M, Leidy NK, Wallen GR. A systematic approach for studying the signs and symptoms of fever in adult patients: the fever assessment tool (FAST). Health Qual Life Outcomes. 2017 Apr 27;15(1):84. doi: 10.1186/s12955-017-0644-6.
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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.
Nancy Ames, R.N. principal investigator
National Institutes of Health Clinical Center (CC)
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 Fever, run by National Institutes of Health Clinical Center (CC) 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 12 inclusion and 0 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: stopped early, as of the sponsor's last update on 6 Oct 2017. 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 stopped early. Results are not available in the source record.
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?
Symptoms of fever (time frame: Throughout in patient admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01287143, which also lists 4 linked publications.
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 6 Oct 2017.