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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Fever, Anxiety, Help-Seeking Behavior, Virus Diseases, Bacterial Infections, Overdose of Analgesic Drug

Intervention / Treatment
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* Device: FeverFriend mobile application


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All patients<br>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. | Device: FeverFriend mobile application<br>* Registration, documentation of patients profile, documentation of fever events, following advice regarding the patient and the care-giver, documentation of follow up notifications.<br>* Other names: FeverFriend web knowledge base (homepage);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fever events outcome, condition of the patient 1 | body temperature grade Celsius | During the period of single fever event (up to 5 days) | 
| Fever events outcome, condition of the patient 2 | duration of fever in days | During the period of single fever event (up to 5 days) | 
| 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) | 
| 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) | 
| Fever events outcome, condition of the patient 5 | ventilation: rate per minute | 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) | During the period of single fever event (up to 5 days) | 
| Fever events outcome, condition of the patient 7 | skin condition: color and rash | During the period of single fever event (up to 5 days) | 
| Fever events outcome, condition of the patient 8 | pulse rate beat per minute | During the period of single fever event (up to 5 days) | 
| Fever events outcome, condition of the patient 9 | crying quality (no, normal, abnormal) | During the period of single fever event (up to 5 days) | 
| Fever events outcome, condition of the patient 10 | eating last time in hours | 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) | 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) | 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 | During the period of single fever event (up to 5 days) | 
| Fever events outcome, condition of the patient 14 | seizure yes - no | During the period of single fever event (up to 5 days) | 
| Fever events outcome, condition of the patient 15 | wry neck yes - no | 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 | 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) | 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) | 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) | 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 | 48 hours after illness resolving | 
| Action taken, evaluation 2 | Use of medication no - yes (type and dosage) | 48 hours after illness resolving | 
| Action taken, evaluation 3 | Use of medical providers service no - yes (institution type) | 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) | 48 hours after last fever event documentation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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childhood fever, help-seeking behavior, fever phobia, mobile application, guideline adherence, antipyretics, antibiotics, health literacy, socio-economic assessment