LázBarát™ (FeverFriend™) Projekt: Attitude Toward Fever and Its Change in the Healthcare System
NCT ID: NCT04633603
Last Updated: 2024-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
10000 participants
OBSERVATIONAL
2020-01-15
2028-01-15
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion criteria: severe underlying disease, patient who needs hospitalization.
100 Years
ALL
Yes
Sponsors
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Dr. Szőke Henrik és Társa Egészségügyi Szolgáltató Kft.
UNKNOWN
Hungarian Medical Chamber / Magyar Orvosi Kamara (Győr-Moson-Sopron Megye)
UNKNOWN
University of Witten
UNKNOWN
Heim Pál Children's Hospital / Heim Pál Országos Gyermekgyógyászati Intézet
UNKNOWN
Hungarian Emergency Service / Országos Mentőszolgálat
UNKNOWN
Civil Support Közhasznú Nonprofit Kft.
UNKNOWN
University of Pecs
OTHER
Responsible Party
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Principal Investigators
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Szőke Henrik, Dr
Role: PRINCIPAL_INVESTIGATOR
University of Pecs Faculty of Health Sciences
Locations
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University of Pecs
Pécs, , Hungary
Countries
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References
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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.
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.
Related Links
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Fever under 5s - assessment and initial management, NICE Guideline 2019
Other Identifiers
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IV/209-1/2020/EKU
Identifier Type: -
Identifier Source: org_study_id