FeverNCT04633603
LázBarát™ (FeverFriend™) Projekt: Attitude Toward Fever and Its Change in the Healthcare System
An observational study of Fever and Anxiety, run by University of Pecs at 1 site in Hungary.
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. Read more about this study
- Who is it for?
- Ages Up to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Fever, Anxiety, Help-Seeking Behavior
- What is being tested?
- FeverFriend mobile application
- Type of treatment
- Medical device
- How many people
- 10,000 participants
- Where
- 1 siteHungary
- Study dates
- 15 Jan 2020to 15 Jan 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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).
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Fever, Anxiety, Help-Seeking Behavior, Virus Diseases, Bacterial Infections, Overdose of Analgesic Drug
- Being tested
- FeverFriend mobile application
- Keywords
- childhood fever, help-seeking behavior, fever phobia, mobile application, guideline adherence, antipyretics, antibiotics, health literacy, socio-economic assessment
- Medical subject headings
- Fever, Anxiety Disorders, Help-Seeking Behavior, Virus Diseases, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FeverFriend mobile applicationDevice
Also called FeverFriend web knowledge base (homepage)
Registration, documentation of patients profile, documentation of fever events, following advice regarding the patient and the care-giver, documentation of follow up notifications.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: FeverFriend mobile application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fever events outcome, condition of the patient 1
body temperature grade Celsius
Measured: During the period of single fever event (up to 5 days)
Fever events outcome, condition of the patient 2
duration of fever in days
Measured: During the period of single fever event (up to 5 days)
Fever events outcome, condition of the patient 3
medication, vaccination type and dosage
Measured: 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
Measured: During the period of single fever event (up to 5 days)
Fever events outcome, condition of the patient 5
ventilation: rate per minute
Measured: 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)
Measured: During the period of single fever event (up to 5 days)
Fever events outcome, condition of the patient 7
skin condition: color and rash
Measured: During the period of single fever event (up to 5 days)
Fever events outcome, condition of the patient 8
pulse rate beat per minute
Measured: During the period of single fever event (up to 5 days)
Fever events outcome, condition of the patient 9
crying quality (no, normal, abnormal)
Measured: During the period of single fever event (up to 5 days)
Fever events outcome, condition of the patient 10
eating last time in hours
Measured: 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)
Measured: 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)
Measured: 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
Measured: During the period of single fever event (up to 5 days)
Fever events outcome, condition of the patient 14
seizure yes - no
Measured: During the period of single fever event (up to 5 days)
Fever events outcome, condition of the patient 15
wry neck yes - no
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 48 hours after illness resolving
Action taken, evaluation 2
Use of medication no - yes (type and dosage)
Measured: 48 hours after illness resolving
Action taken, evaluation 3
Use of medical providers service no - yes (institution type)
Measured: 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)
Measured: 48 hours after last fever event documentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start15 Jan 2020
- Primary completion15 Jan 2028 (estimated)
- Study completion15 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of Pecs
- Sponsor type
- University, hospital or other
- 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.
- Responsible party
- Sponsor
- Investigators
- Szőke Henrik, Dr, Principal investigator, University of Pecs Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633603
- Sponsor's protocol ID
- IV/209-1/2020/EKU
- Status last verified
- Dec 2024
- First submitted
- 29 Oct 2020
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 21357332Rawson 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.
PubMed 28101333James 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.
PubMed 25781411Purssell 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.
PubMed 26643444Poirier 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.
PubMed 20488812Sakai 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.
PubMed 21883684