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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Virus Diseases; Bacterial Infections; Anxiety; Fever; Help-Seeking Behavior; Overdose of Analgesic Drug
• Intervention / Treatment: Device: FeverFriend mobile application

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:

1. The mobile application and knowledge base increases health literacy of parents and professionals.
2. The application will change the uncertain and/or negative attitude toward fever.
3. 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 Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

Study Locations

• Hungary
  • Pecs, Hungary, 7622
    • University of Pecs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 100 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: FeverFriend web knowledge base (homepage)

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline characteristics (profile of patient) 1	date of birth	at registry on the first day
Baseline characteristics (profile of patient) 2	gender: male - female - other	at registry on the first day
Baseline characteristics (profile) 3	height centimeter	at registry on the first day
Baseline characteristics (profile) 4	weight kilogram	at registry on the first day
Baseline characteristics (profile) 5	chronic disease yes - no	at registry on the first day
Baseline characteristics (profile) 6	Former use of medication in the last 12 month (antipyretics, antibiotics) yes - no, number	at registry on the first day
Baseline characteristics (profile) 7	Former use of healthcare providers service in the last 12 month no - yes, number of events and type of institution	at registry on the first day
Baseline characteristics (profile) 8	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; )	at registry on the first day

Collaborators and Investigators

• Sponsor: University of Pecs
• 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.
• Investigators: Principal Investigator: Szőke Henrik, Dr, University of Pecs Faculty of Health Sciences

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• Fever under 5s - assessment and initial management, NICE Guideline 2019

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 15, 2020
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: October 29, 2020
• First Submitted That Met QC Criteria: November 12, 2020
• First Posted (ACTUAL): November 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 4, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: guideline adherence; health literacy; antibiotics; mobile application; antipyretics; childhood fever; help-seeking behavior; fever phobia; socio-economic assessment
• Additional Relevant MeSH Terms: Infections; Wounds and Injuries; Bacterial Infections and Mycoses; Body Temperature Changes; Heat Stress Disorders; Virus Diseases; Hyperthermia; Fever; Bacterial Infections
• Other Study ID Numbers: IV/209-1/2020/EKU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No