L zBar t (FeverFriend ) Projekt: Attitude Toward Fever and Its Change in the Healthcare System

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    10000
  • sponsor
    University of Pecs
Updated on 27 January 2021

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.

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 Chi 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 Pcs Hungarian Medical Chamber (Gyr-Moson-Sopron Megye) University of Witten Heim Pl Childrens Hospital National Emergency Service Healthware Tancsad Kft. Dr. Szke Henrik s Trsa Egszsggyi Szolgltat Kft.

Organizational tasks are conducted in the framework of the University of Pcs, Faculty of Health Sciences and by the Civil Support Kzhaszn Nonprofit Kft.

Details
Condition Bacterial Infection, Bacterial Infections, Fever, Fever, Viral infection, Viral Infections, ANXIETY NEUROSIS, Anxiety Disorders, Generalized Anxiety Disorder (GAD), Anxiety Disorders (Pediatric), Generalized Anxiety Disorder (GAD - Pediatric), Anxiety, Anxiety Disorders (Pediatric), Generalized Anxiety Disorder (GAD), Generalized Anxiety Disorder (GAD - Pediatric), Anxiety Symptoms, Anxiety Disorders, Bacterial Infections, Viral Infections, anxiety disorder, pyrexia, hyperthermia, fevers, anxious, bacterial disease, Help-Seeking Behavior, Overdose of Analgesic Drug, Help-Seeking Behavior, Help-Seeking Behavior, Help-Seeking Behavior
Treatment FeverFriend mobile application
Clinical Study IdentifierNCT04633603
SponsorUniversity of Pecs
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

-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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note