Anxiety, Bacterial Infections, Fever, Help-Seeking Behavior, Overdose of Analgesic Drug, Virus Diseases
Conditions
Keywords
childhood fever, help-seeking behavior, fever phobia, mobile application, guideline adherence, antipyretics, antibiotics, health literacy, socio-economic assessment
Brief 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. 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
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: 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.
Interventions
DEVICEFeverFriend 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.
Sponsors
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.
University of Pecs
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 100 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Action taken, evaluation 4 | 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) |
| Fever events outcome, condition of the patient 15 | During the period of single fever event (up to 5 days) | wry neck yes - no |
| Fever events outcome, condition of the patient 16 | During the period of single fever event (up to 5 days) | pain yes - no pain location local - general duration hours |
| Care-givers state 1 | 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) |
| Care-givers state 2 | 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) |
| Care-givers state 3 | 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) |
| Action taken, evaluation 1 | 48 hours after illness resolving | Use of medication, use of medical providers service, utility of the device and knowledge base |
| Action taken, evaluation 2 | 48 hours after illness resolving | Use of medication no - yes (type and dosage) |
| Action taken, evaluation 3 | 48 hours after last fever event documentation | Use of medical providers service no - yes (institution type) |
| Fever events outcome, condition of the patient 1 | During the period of single fever event (up to 5 days) | body temperature grade Celsius |
| Fever events outcome, condition of the patient 2 | During the period of single fever event (up to 5 days) | duration of fever in days |
| Fever events outcome, condition of the patient 3 | Before and during the period of single fever event (up to 20 days) | medication, vaccination type and dosage |
| Fever events outcome, condition of the patient 4 | During the period of single fever event (up to 5 days) | hydration: normal - somewhat decreased - severely decreased |
| Fever events outcome, condition of the patient 5 | During the period of single fever event (up to 5 days) | ventilation: rate per minute |
| Fever events outcome, condition of the patient 6 | 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) |
| Fever events outcome, condition of the patient 7 | During the period of single fever event (up to 5 days) | skin condition: color and rash |
| Fever events outcome, condition of the patient 8 | During the period of single fever event (up to 5 days) | pulse rate beat per minute |
| Fever events outcome, condition of the patient 9 | During the period of single fever event (up to 5 days) | crying quality (no, normal, abnormal) |
| Fever events outcome, condition of the patient 10 | During the period of single fever event (up to 5 days) | eating last time in hours |
| Fever events outcome, condition of the patient 11 | During the period of single fever event (up to 5 days) | urination painful or smelly (yes - no) |
| Fever events outcome, condition of the patient 12 | During the period of single fever event (up to 5 days) | awareness: normal - sleepy - no (subjective scale; minimum = best = normal; maximum = worst = no) |
| Fever events outcome, condition of the patient 13 | During the period of single fever event (up to 5 days) | exotic trip in the last 12 month yes - no |
| Fever events outcome, condition of the patient 14 | During the period of single fever event (up to 5 days) | seizure yes - no |
Other
| Measure | Time frame | Description |
|---|---|---|
| Baseline characteristics (profile of patient) 2 | at registry on the first day | gender: male - female - other |
| Baseline characteristics (profile) 3 | at registry on the first day | height centimeter |
| Baseline characteristics (profile) 4 | at registry on the first day | weight kilogram |
| Baseline characteristics (profile) 5 | at registry on the first day | chronic disease yes - no |
| Baseline characteristics (profile) 6 | at registry on the first day | Former use of medication in the last 12 month (antipyretics, antibiotics) yes - no, number |
| Baseline characteristics (profile) 7 | 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 |
| Baseline characteristics (profile) 8 | 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; ) |
| Baseline characteristics (profile of patient) 1 | at registry on the first day | date of birth |
Countries
Hungary
Outcome results
None listed