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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04633603
• Other study ID #: IV/209-1/2020/EKU
• Status: Enrolling by invitation
• Start date: January 15, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2022
• Source: University of Pecs
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10000
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Bacterial Infections
• Fever
• Help-Seeking Behavior
• Hyperthermia
• Overdose of Analgesic Drug
• Virus Diseases

Intervention

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.

Locations

Country	Name	City	State
Hungary	University of Pecs	Pecs

Sponsors (7)

Lead Sponsor	Collaborator
University of Pecs	Civil Support Közhasznú Nonprofit Kft., Dr. Szoke Henrik és Társa Egészségügyi Szolgáltató Kft., Heim Pál Children's Hospital / Heim Pál Országos Gyermekgyógyászati Intézet, Hungarian Emergency Service / Országos Mentoszolgálat, Hungarian Medical Chamber / Magyar Orvosi Kamara (Gyor-Moson-Sopron Megye), University of Witten

Country where clinical trial is conducted

Hungary, 

References & Publications (11)

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

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

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. Review. — View 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. — View 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. Review. — View 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. — View 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. — View 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. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Baseline characteristics (profile of patient) 1	date of birth	at registry on the first day
Other	Baseline characteristics (profile of patient) 2	gender: male - female - other	at registry on the first day
Other	Baseline characteristics (profile) 3	height centimeter	at registry on the first day
Other	Baseline characteristics (profile) 4	weight kilogram	at registry on the first day
Other	Baseline characteristics (profile) 5	chronic disease yes - no	at registry on the first day
Other	Baseline characteristics (profile) 6	Former use of medication in the last 12 month (antipyretics, antibiotics) yes - no, number	at registry on the first day
Other	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
Other	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
Primary	Fever events outcome, condition of the patient 1	body temperature grade Celsius	During the period of single fever event (up to 5 days)
Primary	Fever events outcome, condition of the patient 2	duration of fever in days	During the period of single fever event (up to 5 days)
Primary	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)
Primary	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)
Primary	Fever events outcome, condition of the patient 5	ventilation: rate per minute	During the period of single fever event (up to 5 days)
Primary	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)
Primary	Fever events outcome, condition of the patient 7	skin condition: color and rash	During the period of single fever event (up to 5 days)
Primary	Fever events outcome, condition of the patient 8	pulse rate beat per minute	During the period of single fever event (up to 5 days)
Primary	Fever events outcome, condition of the patient 9	crying quality (no, normal, abnormal)	During the period of single fever event (up to 5 days)
Primary	Fever events outcome, condition of the patient 10	eating last time in hours	During the period of single fever event (up to 5 days)
Primary	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)
Primary	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)
Primary	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)
Primary	Fever events outcome, condition of the patient 14	seizure yes - no	During the period of single fever event (up to 5 days)
Primary	Fever events outcome, condition of the patient 15	wry neck yes - no	During the period of single fever event (up to 5 days)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	Action taken, evaluation 1	Use of medication, use of medical providers service, utility of the device and knowledge base	48 hours after illness resolving
Primary	Action taken, evaluation 2	Use of medication no - yes (type and dosage)	48 hours after illness resolving
Primary	Action taken, evaluation 3	Use of medical providers service no - yes (institution type)	48 hours after last fever event documentation
Primary	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

External Links

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