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NCT Number: NCT04633603

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FeverFriend mobile application

Device

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)

Primary outcomes

  1. Fever events outcome, condition of the patient 1

    Time frame: During the period of single fever event (up to 5 days)

    body temperature grade Celsius

  2. Fever events outcome, condition of the patient 2

    Time frame: During the period of single fever event (up to 5 days)

    duration of fever in days

  3. Fever events outcome, condition of the patient 3

    Time frame: Before and during the period of single fever event (up to 20 days)

    medication, vaccination type and dosage

  4. Fever events outcome, condition of the patient 4

    Time frame: During the period of single fever event (up to 5 days)

    hydration: normal - somewhat decreased - severely decreased

  5. Fever events outcome, condition of the patient 5

    Time frame: During the period of single fever event (up to 5 days)

    ventilation: rate per minute

  6. Fever events outcome, condition of the patient 6

    Time frame: During the period of single fever event (up to 5 days)

    ventilation: wheezing and dyspnea (subjective scale 1-2-3-4-5; minimum 1; maximum 5; 1 is no symptom = better, 5 is the worst)

  7. Fever events outcome, condition of the patient 7

    Time frame: During the period of single fever event (up to 5 days)

    skin condition: color and rash

  8. Fever events outcome, condition of the patient 8

    Time frame: During the period of single fever event (up to 5 days)

    pulse rate beat per minute

  9. Fever events outcome, condition of the patient 9

    Time frame: During the period of single fever event (up to 5 days)

    crying quality (no, normal, abnormal)

  10. Fever events outcome, condition of the patient 10

    Time frame: During the period of single fever event (up to 5 days)

    eating last time in hours

  11. Fever events outcome, condition of the patient 11

    Time frame: During the period of single fever event (up to 5 days)

    urination painful or smelly (yes - no)

  12. Fever events outcome, condition of the patient 12

    Time frame: During the period of single fever event (up to 5 days)

    awareness: normal - sleepy - no (subjective scale; minimum = best = normal; maximum = worst = no)

  13. Fever events outcome, condition of the patient 13

    Time frame: During the period of single fever event (up to 5 days)

    exotic trip in the last 12 month yes - no

  14. Fever events outcome, condition of the patient 14

    Time frame: During the period of single fever event (up to 5 days)

    seizure yes - no

  15. Fever events outcome, condition of the patient 15

    Time frame: During the period of single fever event (up to 5 days)

    wry neck yes - no

  16. Fever events outcome, condition of the patient 16

    Time frame: During the period of single fever event (up to 5 days)

    pain yes - no pain location local - general duration hours

  17. Care-givers state 1

    Time frame: During the period of fever event (up to 5 days)

    Care-givers own feeling about the progress of patients illness (subjective scale,1 best = optimal - 2 = not sure - 3 = worst = very worried)

  18. Care-givers state 2

    Time frame: During the period of fever event (up to 5 days)

    Care-givers personal opinion about patients state: (subjective scale: minimum = best = not severe, middle = somewhat severe, maximum = worst = very severe)

  19. Care-givers state 3

    Time frame: During the period of fever event (up to 5 days)

    Care-givers self-confidence in handling the situation (subjective scale: maximum = confident; worse = somewhat confident, even worse = not really, minimum = worst = not at all)

  20. Action taken, evaluation 1

    Time frame: 48 hours after illness resolving

    Use of medication, use of medical providers service, utility of the device and knowledge base

  21. Action taken, evaluation 2

    Time frame: 48 hours after illness resolving

    Use of medication no - yes (type and dosage)

  22. Action taken, evaluation 3

    Time frame: 48 hours after last fever event documentation

    Use of medical providers service no - yes (institution type)

  23. Action taken, evaluation 4

    Time frame: 48 hours after last fever event documentation

    Utility of the device and knowledge base (subjective scale 1-2-3-4-5; minimum 1 = worst; maximum 5 = best)

Other outcomes

  1. Baseline characteristics (profile of patient) 1

    Time frame: at registry on the first day

    date of birth

  2. Baseline characteristics (profile of patient) 2

    Time frame: at registry on the first day

    gender: male - female - other

  3. Baseline characteristics (profile) 3

    Time frame: at registry on the first day

    height centimeter

  4. Baseline characteristics (profile) 4

    Time frame: at registry on the first day

    weight kilogram

  5. Baseline characteristics (profile) 5

    Time frame: at registry on the first day

    chronic disease yes - no

  6. Baseline characteristics (profile) 6

    Time frame: at registry on the first day

    Former use of medication in the last 12 month (antipyretics, antibiotics) yes - no, number

  7. Baseline characteristics (profile) 7

    Time frame: at registry on the first day

    Former use of healthcare providers service in the last 12 month no - yes, number of events and type of institution

  8. Baseline characteristics (profile) 8

    Time frame: at registry on the first day

    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; )

Sponsors and collaborators

Lead sponsor

University of Pecs

Other

Collaborators

  • Civil Support Közhasznú Nonprofit Kft.
  • Dr. Szőke Henrik és Társa Egészségügyi Szolgáltató Kft.
  • Heim Pál Children's Hospital / Heim Pál Országos Gyermekgyógyászati Intézet
  • Hungarian Emergency Service / Országos Mentőszolgálat
  • Hungarian Medical Chamber / Magyar Orvosi Kamara (Győr-Moson-Sopron Megye)
  • University of Witten

Registry information

Important dates

Study start
2020
Primary completion
2028
Study completion
2028
First posted
Nov 18, 2020
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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