Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Anxiety
  • Bacterial Infections
  • Fever
  • Help-Seeking Behavior
  • Overdose of Analgesic Drug
  • Virus Diseases
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Younger than 100 years
Gender
Both males and females

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. ...

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 (Gy?r-Moson-Sopron Megye) University of Witten Heim Pál Childrens Hospital National Emergency Service Healthware Tanácsadó Kft. Dr. Sz?ke 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.

Tracking Information

NCT #
NCT04633603
Collaborators
  • Dr. Sz?ke Henrik és Társa Egészségügyi Szolgáltató Kft.
  • Hungarian Medical Chamber / Magyar Orvosi Kamara (Gy?r-Moson-Sopron Megye)
  • University of Witten
  • Heim Pál Children's Hospital / Heim Pál Országos Gyermekgyógyászati Intézet
  • Hungarian Emergency Service / Országos Ment?szolgálat
  • Civil Support Közhasznú Nonprofit Kft.
Investigators
Principal Investigator: Sz?ke Henrik, Dr University of Pecs Faculty of Health Sciences