LázBarát™ (FeverFriend™) Projekt: Attitude Toward Fever and Its Change in the Healthcare System

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ClinicalTrials.gov Identifier: NCT04633603

Recruitment Status : Enrolling by invitation

First Posted : November 18, 2020

Last Update Posted : November 7, 2022

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborators:

Dr. Szőke Henrik és Társa Egészségügyi Szolgáltató Kft.

Hungarian Medical Chamber / Magyar Orvosi Kamara (Győr-Moson-Sopron Megye)

University of Witten

Heim Pál Children's Hospital / Heim Pál Országos Gyermekgyógyászati Intézet

Hungarian Emergency Service / Országos Mentőszolgálat

Civil Support Közhasznú Nonprofit Kft.

Information provided by (Responsible Party):

University of Pecs

Study Description

Brief Summary:

The positive effects of fever are supported by a number of physiological, pathophysiological and clinical evidence. However, the negative attitude toward fever is widespread and have become persistent. According to sociological research, this is based on two main factors: comfort and fear. To change this negative attitude, awareness needs to be raised and the attitude toward fever among health care workers and the lay public needs to be reframed positively. Furthermore, the role of media users is essential, especially among the young generation.

The current Hungarian recommendation/protocol is valid since 2011 (Professional protocol of the Ministry of National Resources: Caring for a child with fever, the recommendation of the College of Pediatric and Pediatric However, the practical implementation among health professionals and the laity public is low.

Based on this protocol and current international guidelines (NICE) clinicians developed a protocol and register, where parents and caregivers can document the symptoms and runoff of fever as well as receive feedback on severity and appropriate management.

The project aims to increase the evidence-based (EBM) guideline adherence, to reduce the unnecessary use of antipyretics and antibiotics, as well as the load on the current healthcare system. The documentation of the collected data allows the investigators to map and analyze (stats) socio-demographic behavior both on individual and societal level.

Condition or disease	Intervention/treatment
Fever Anxiety Help-Seeking Behavior Virus Diseases Bacterial Infections Overdose of Analgesic Drug	Device: FeverFriend mobile application

Show detailed description

Detailed Description:

Goal:

Reframing the negative attitude toward fever. Reducing unnecessary use of drugs (antipyretics and antibiotics) as well as lower the number of medical consultations. In order, the investigators will use a media-based mobile application and a web knowledge base. Languages English and Hungarian.

Hypotheses:

The mobile application and knowledge base increases health literacy of parents and professionals.
The application will change the uncertain and/or negative attitude toward fever.
The positive change in attitude will influence antipyretic and consecutive antibiotic use, lower medical provider contact, enhancing the practical implementation of guidelines.

Method:

Noninvasive, noninterventional, self-reported, observational, prospective cohort study under real-life conditions.

Data: provided by caregivers and/or patients are grouped and classified based on the severity of the disease behind the fever.

Data analysis:

Analysis sample size calculation: To analyze guideline-adherent and non-adherent behavior at a 95% binomial confidence interval with an accuracy of +/- 2%, at least 500 fever phases are required if the smaller group comprises 5%. The investigators a-priory estimation based on surveys is that only about 15% of caretakers have a guideline-conforming approach to the management of fever, hence 1,500 fever events are needed for the planned accuracy. If adherent and non-adherent groups are approximately the same size, a maximum of ca. 2,500 fever phases are required.

The exact incidence of fever per age group is not yet known. Larger samples are required - and expected - for subgroup analyses (e.g. between age groups). Recruitment will therefore continue throughout to year 3 and beyond. The Chi² test is used to compare two subgroups. Sample size planning cannot take unplanned multiple testing into account, so the results can only be interpreted exploratively.

Subsample calculations: If a difference of 5% between two frequencies is interpreted as clinically significant, at a power of 80% and an alpha error probability of 5% assuming normal distribution in both subsamples, the following sample sizes are required: For a very rare sample, ca. 200 cases per subsample are sufficient. If the rate is around 50%, ca. 1,600 cases per subsample are required.

Software: IBM SPSS Statistics 22, Microsoft Excel ...

Research partners providing theoretical and professional background:

University of Pécs Hungarian Medical Chamber (Győr-Moson-Sopron Megye) University of Witten Heim Pál Childrens Hospital National Emergency Service Healthware Tanácsadó Kft. Dr. Szőke Henrik és Társa Egészségügyi Szolgáltató Kft.

Organizational tasks are conducted in the framework of the University of Pécs, Faculty of Health Sciences and by the Civil Support Közhasznú Nonprofit Kft.

Study Design

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Study Type :	Observational [Patient Registry]
Estimated Enrollment :	10000 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Target Follow-Up Duration:	3 Years
Official Title:	LázBarát™ (FeverFriend™) Projekt: Attitude Toward Fever and Its Change in the Healthcare System
Actual Study Start Date :	January 15, 2020
Estimated Primary Completion Date :	December 31, 2023
Estimated Study Completion Date :	December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
All patients There is no pre-specified group or subgroup of participant(s) assigned to receive the specific intervention(s) (or no intervention) according to the protocol. All patients get the same possibility to register their data and follow management advice.	Device: FeverFriend mobile application Registration, documentation of patients profile, documentation of fever events, following advice regarding the patient and the care-giver, documentation of follow up notifications. Other Name: FeverFriend web knowledge base (homepage)

Outcome Measures

Primary Outcome Measures :

Fever events outcome, condition of the patient 1 [ Time Frame: During the period of single fever event (up to 5 days) ]
body temperature grade Celsius
Fever events outcome, condition of the patient 2 [ Time Frame: During the period of single fever event (up to 5 days) ]
duration of fever in days
Fever events outcome, condition of the patient 3 [ Time Frame: Before and during the period of single fever event (up to 20 days) ]
medication, vaccination type and dosage
Fever events outcome, condition of the patient 4 [ Time Frame: During the period of single fever event (up to 5 days) ]
hydration: normal - somewhat decreased - severely decreased
Fever events outcome, condition of the patient 5 [ Time Frame: During the period of single fever event (up to 5 days) ]
ventilation: rate per minute
Fever events outcome, condition of the patient 6 [ Time Frame: During the period of single fever event (up to 5 days) ]
ventilation: wheezing and dyspnea (subjective scale 1-2-3-4-5; minimum 1; maximum 5; 1 is no symptom = better, 5 is the worst)
Fever events outcome, condition of the patient 7 [ Time Frame: During the period of single fever event (up to 5 days) ]
skin condition: color and rash
Fever events outcome, condition of the patient 8 [ Time Frame: During the period of single fever event (up to 5 days) ]
pulse rate beat per minute
Fever events outcome, condition of the patient 9 [ Time Frame: During the period of single fever event (up to 5 days) ]
crying quality (no, normal, abnormal)
Fever events outcome, condition of the patient 10 [ Time Frame: During the period of single fever event (up to 5 days) ]
eating last time in hours
Fever events outcome, condition of the patient 11 [ Time Frame: During the period of single fever event (up to 5 days) ]
urination painful or smelly (yes - no)
Fever events outcome, condition of the patient 12 [ Time Frame: During the period of single fever event (up to 5 days) ]
awareness: normal - sleepy - no (subjective scale; minimum = best = normal; maximum = worst = no)
Fever events outcome, condition of the patient 13 [ Time Frame: During the period of single fever event (up to 5 days) ]
exotic trip in the last 12 month yes - no
Fever events outcome, condition of the patient 14 [ Time Frame: During the period of single fever event (up to 5 days) ]
seizure yes - no
Fever events outcome, condition of the patient 15 [ Time Frame: During the period of single fever event (up to 5 days) ]
wry neck yes - no
Fever events outcome, condition of the patient 16 [ Time Frame: During the period of single fever event (up to 5 days) ]
pain yes - no pain location local - general duration hours
Care-givers state 1 [ Time Frame: During the period of fever event (up to 5 days) ]
Care-givers own feeling about the progress of patients illness (subjective scale,1 best = optimal - 2 = not sure - 3 = worst = very worried)
Care-givers state 2 [ Time Frame: During the period of fever event (up to 5 days) ]
Care-givers personal opinion about patients state: (subjective scale: minimum = best = not severe, middle = somewhat severe, maximum = worst = very severe)
Care-givers state 3 [ Time Frame: During the period of fever event (up to 5 days) ]
Care-givers self-confidence in handling the situation (subjective scale: maximum = confident; worse = somewhat confident, even worse = not really, minimum = worst = not at all)
Action taken, evaluation 1 [ Time Frame: 48 hours after illness resolving ]
Use of medication, use of medical providers service, utility of the device and knowledge base
Action taken, evaluation 2 [ Time Frame: 48 hours after illness resolving ]
Use of medication no - yes (type and dosage)
Action taken, evaluation 3 [ Time Frame: 48 hours after last fever event documentation ]
Use of medical providers service no - yes (institution type)
Action taken, evaluation 4 [ Time Frame: 48 hours after last fever event documentation ]
Utility of the device and knowledge base (subjective scale 1-2-3-4-5; minimum 1 = worst; maximum 5 = best)

Other Outcome Measures:

Baseline characteristics (profile of patient) 1 [ Time Frame: at registry on the first day ]
date of birth
Baseline characteristics (profile of patient) 2 [ Time Frame: at registry on the first day ]
gender: male - female - other
Baseline characteristics (profile) 3 [ Time Frame: at registry on the first day ]
height centimeter
Baseline characteristics (profile) 4 [ Time Frame: at registry on the first day ]
weight kilogram
Baseline characteristics (profile) 5 [ Time Frame: at registry on the first day ]
chronic disease yes - no
Baseline characteristics (profile) 6 [ Time Frame: at registry on the first day ]
Former use of medication in the last 12 month (antipyretics, antibiotics) yes - no, number
Baseline characteristics (profile) 7 [ Time Frame: at registry on the first day ]
Former use of healthcare providers service in the last 12 month no - yes, number of events and type of institution
Baseline characteristics (profile) 8 [ Time Frame: at registry on the first day ]
Caregivers former state at fever events of the patient in the last 12 month: care-givers state of mind, level of anxiety, behavior (subjective scale 1-2-3-4; )

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:	up to 100 Years (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Participants are included if they downloaded and registered the mobile application. The use of the application is voluntary. A minimum of 100 individuals are included, a maximum sample size is not specified. Participants are between the age of 0-100. The target population is mainly children (0-18y).

Criteria

Inclusion criteria for patients: 0-100 years age, home or ambulant care, accepting the legal notice (including study-protocol, privacy- and data management), documenting patients profile. Eligibility for documentation of separate fever events: recording at least temperature and measurement method (device and place).

Exclusion criteria: severe underlying disease, patient who needs hospitalization.

Contacts and Locations

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): NCT04633603

Locations

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Hungary
University of Pecs
Pecs, Hungary, 7622

Sponsors and Collaborators

University of Pecs

Dr. Szőke Henrik és Társa Egészségügyi Szolgáltató Kft.

Hungarian Medical Chamber / Magyar Orvosi Kamara (Győr-Moson-Sopron Megye)

University of Witten

Heim Pál Children's Hospital / Heim Pál Országos Gyermekgyógyászati Intézet

Hungarian Emergency Service / Országos Mentőszolgálat

Civil Support Közhasznú Nonprofit Kft.

Investigators

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Principal Investigator:	Szőke Henrik, Dr	University of Pecs Faculty of Health Sciences

More Information

Additional Information:

Fever under 5s - assessment and initial management, NICE Guideline 2019 This link exits the ClinicalTrials.gov site

Publications of Results:

Purssell E, Collin J. Fever phobia: The impact of time and mortality--a systematic review and meta-analysis. Int J Nurs Stud. 2016 Apr;56:81-9. doi: 10.1016/j.ijnurstu.2015.11.001. Epub 2015 Nov 17.

Poirier MP, Collins EP, McGuire E. Fever phobia: a survey of caregivers of children seen in a pediatric emergency department. Clin Pediatr (Phila). 2010 Jun;49(6):530-4. doi: 10.1177/0009922809355312. Epub 2010 May 19.

Sakai R, Okumura A, Marui E, Niijima S, Shimizu T. Does fever phobia cross borders? The case of Japan. Pediatr Int. 2012 Feb;54(1):39-44. doi: 10.1111/j.1442-200X.2011.03449.x. Epub 2011 Oct 30.

Other Publications:

Abu-Baker, N.N., Gharaibeh, H.F., Al-Zoubi, H.M., Savage, C., Gharaibeh, M.K., 2013. Mothers' knowledge and practices of managing minor illnesses of children under five years. J. Res. Nurs. 18 (7), 651-666.

Alex-Hart, B.A., Frank-Briggs, A.I., 2011. Mothers' perception of fever management in children. Niger. Health J. 11 (2), 69-72.

Ayatollahi, J., Behjati, M., Shahcheraghi, S.H., 2014. Mothers' knowledge, perception and management of fever in children. Paediatr. Today 1 (1), 14-17.

Fekete Ferenc dr., Láz, ami átlépi az ingerküszöbünket, Gyermekorvos Továbbképzés, 2014. 13. évf. 1. szám

A Nemzeti Erőforrás Minisztérium szakmai protokollja: Lázas gyermekek ellátásáról, Magyar közlöny, 2011

Section on Clinical Pharmacology and Therapeutics; Committee on Drugs; Sullivan JE, Farrar HC. Fever and antipyretic use in children. Pediatrics. 2011 Mar;127(3):580-7. doi: 10.1542/peds.2010-3852. Epub 2011 Feb 28.

Rawson TM, Moore LS, Tivey AM, Tsao A, Gilchrist M, Charani E, Holmes AH. Behaviour change interventions to influence antimicrobial prescribing: a cross-sectional analysis of reports from UK state-of-the-art scientific conferences. Antimicrob Resist Infect Control. 2017 Jan 13;6:11. doi: 10.1186/s13756-017-0170-7. eCollection 2017.

James S, Rao SV, Granger CB. Registry-based randomized clinical trials--a new clinical trial paradigm. Nat Rev Cardiol. 2015 May;12(5):312-6. doi: 10.1038/nrcardio.2015.33. Epub 2015 Mar 17.

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Responsible Party:	University of Pecs
ClinicalTrials.gov Identifier:	NCT04633603
Other Study ID Numbers:	IV/209-1/2020/EKU
First Posted:	November 18, 2020 Key Record Dates
Last Update Posted:	November 7, 2022
Last Verified:	November 2022

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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 University of Pecs:


childhood fever help-seeking behavior fever phobia mobile application guideline adherence	antipyretics antibiotics health literacy socio-economic assessment

Additional relevant MeSH terms:

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Bacterial Infections Virus Diseases Fever Hyperthermia Body Temperature Changes	Heat Stress Disorders Wounds and Injuries Bacterial Infections and Mycoses Infections

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