Ignite Creation Date:
2024-05-06 @ 3:27 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04633603
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2022-11-07
First Post:
2020-10-29
Brief Title:
LázBarát FeverFriend Projekt Attitude Toward Fever and Its Change in the Healthcare System
Sponsor:
University of Pecs
Organization:
University of Pecs
Study Overview
Official Title:
LázBarát FeverFriend Projekt Attitude Toward Fever and Its Change in the Healthcare System
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 recommendationprotocol 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
The current Hungarian recommendationprotocol 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 andor 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 andor 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 1500 fever events are needed for the planned accuracy If adherent and non-adherent groups are approximately the same size a maximum of ca 2500 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 eg 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 1600 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
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 andor 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 andor 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 1500 fever events are needed for the planned accuracy If adherent and non-adherent groups are approximately the same size a maximum of ca 2500 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 eg 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 1600 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None