Clinical trial NCT04633603: LázBarát™ (FeverFriend™) Projekt: Attitude Toward Fever and Its Change in the Healthcare System
Official title: LázBarát™ (FeverFriend™) Projekt: Attitude Toward Fever and Its Change in the Healthcare System
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Fever
Anxiety
Help-Seeking Behavior
Virus Diseases
Bacterial Infections
Overdose of Analgesic Drug
Keywords: childhood fever
help-seeking behavior
fever phobia
mobile application
guideline adherence
antipyretics
antibiotics
health literacy
socio-economic assessment
Lead sponsor: University of Pecs
Sponsor class: OTHER
Collaborators: name: Dr. Szőke Henrik és Társa Egészségügyi Szolgáltató Kft.
name: Hungarian Medical Chamber / Magyar Orvosi Kamara (Győr-Moson-Sopron Megye)
name: University of Witten
name: Heim Pál Children's Hospital / Heim Pál Országos Gyermekgyógyászati Intézet
name: Hungarian Emergency Service / Országos Mentőszolgálat
name: Civil Support Közhasznú Nonprofit Kft.
First posted: 2020-11-18
Enrollment: 10000
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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.

Eligibility 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.

Primary outcomes:
measure: Fever events outcome, condition of the patient 1
timeFrame: During the period of single fever event (up to 5 days)
measure: Fever events outcome, condition of the patient 2
timeFrame: During the period of single fever event (up to 5 days)
measure: Fever events outcome, condition of the patient 3
timeFrame: Before and during the period of single fever event (up to 20 days)
measure: Fever events outcome, condition of the patient 4
timeFrame: During the period of single fever event (up to 5 days)
measure: Fever events outcome, condition of the patient 5
timeFrame: During the period of single fever event (up to 5 days)
measure: Fever events outcome, condition of the patient 6
timeFrame: During the period of single fever event (up to 5 days)
measure: Fever events outcome, condition of the patient 7
timeFrame: During the period of single fever event (up to 5 days)
measure: Fever events outcome, condition of the patient 8
timeFrame: During the period of single fever event (up to 5 days)
measure: Fever events outcome, condition of the patient 9
timeFrame: During the period of single fever event (up to 5 days)
measure: Fever events outcome, condition of the patient 10
timeFrame: During the period of single fever event (up to 5 days)
measure: Fever events outcome, condition of the patient 11
timeFrame: During the period of single fever event (up to 5 days)
measure: Fever events outcome, condition of the patient 12
timeFrame: During the period of single fever event (up to 5 days)
measure: Fever events outcome, condition of the patient 13
timeFrame: During the period of single fever event (up to 5 days)
measure: Fever events outcome, condition of the patient 14
timeFrame: During the period of single fever event (up to 5 days)
measure: Fever events outcome, condition of the patient 15
timeFrame: During the period of single fever event (up to 5 days)
measure: Fever events outcome, condition of the patient 16
timeFrame: During the period of single fever event (up to 5 days)
measure: Care-givers state 1
timeFrame: During the period of fever event (up to 5 days)
measure: Care-givers state 2
timeFrame: During the period of fever event (up to 5 days)
measure: Care-givers state 3
timeFrame: During the period of fever event (up to 5 days)
measure: Action taken, evaluation 1
timeFrame: 48 hours after illness resolving
measure: Action taken, evaluation 2
timeFrame: 48 hours after illness resolving
measure: Action taken, evaluation 3
timeFrame: 48 hours after last fever event documentation
measure: Action taken, evaluation 4
timeFrame: 48 hours after last fever event documentation
Secondary outcomes:
Other outcomes:
measure: Baseline characteristics (profile of patient) 1
timeFrame: at registry on the first day
measure: Baseline characteristics (profile of patient) 2
timeFrame: at registry on the first day
measure: Baseline characteristics (profile) 3
timeFrame: at registry on the first day
measure: Baseline characteristics (profile) 4
timeFrame: at registry on the first day
measure: Baseline characteristics (profile) 5
timeFrame: at registry on the first day
measure: Baseline characteristics (profile) 6
timeFrame: at registry on the first day
measure: Baseline characteristics (profile) 7
timeFrame: at registry on the first day
measure: Baseline characteristics (profile) 8
timeFrame: at registry on the first day
Locations:
city: Pecs
country: Hungary
facility: University of Pecs
Study officials:
affiliation: University of Pecs Faculty of Health Sciences
name: Szőke Henrik, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Alex-Hart, B.A., Frank-Briggs, A.I., 2011. Mothers' perception of fever management in children. Niger. Health J. 11 (2), 69-72.
citation: Ayatollahi, J., Behjati, M., Shahcheraghi, S.H., 2014. Mothers' knowledge, perception and management of fever in children. Paediatr. Today 1 (1), 14-17.
citation: Fekete Ferenc dr., Láz, ami átlépi az ingerküszöbünket, Gyermekorvos Továbbképzés, 2014. 13. évf. 1. szám
citation: A Nemzeti Erőforrás Minisztérium szakmai protokollja: Lázas gyermekek ellátásáról, Magyar közlöny, 2011
citation: 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.
citation: 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.
citation: 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.