Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04633603
Recruitment Status : Recruiting
First Posted : November 18, 2020
Last Update Posted : November 18, 2020
Sponsor:
Collaborators:
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.
Information provided by (Responsible Party):
University of Pecs

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.


Condition or disease Intervention/treatment
Fever Anxiety Help-Seeking Behavior Virus Diseases Bacterial Infections Overdose of Analgesic Drug Device: FeverFriend mobile application

Show Show detailed description

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: LázBarát™ (FeverFriend™) Projekt: Attitude Toward Fever and Its Change in the Healthcare System
Actual Study Start Date : January 15, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
All patients
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
Registration, documentation of patients profile, documentation of fever events, following advice regarding the patient and the care-giver, documentation of follow up notifications.
Other Name: FeverFriend web knowledge base (homepage)




Primary Outcome Measures :
  1. Fever events outcome, condition of the patient 1 [ Time Frame: During the period of single fever event (up to 5 days) ]
    body temperature grade Celsius

  2. Fever events outcome, condition of the patient 2 [ Time Frame: During the period of single fever event (up to 5 days) ]
    duration of fever in days

  3. Fever events outcome, condition of the patient 3 [ Time Frame: Before and during the period of single fever event (up to 20 days) ]
    medication, vaccination type and dosage

  4. Fever events outcome, condition of the patient 4 [ Time Frame: During the period of single fever event (up to 5 days) ]
    hydration: normal - somewhat decreased - severely decreased

  5. Fever events outcome, condition of the patient 5 [ Time Frame: During the period of single fever event (up to 5 days) ]
    ventilation: rate per minute

  6. Fever events outcome, condition of the patient 6 [ Time Frame: 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)

  7. Fever events outcome, condition of the patient 7 [ Time Frame: During the period of single fever event (up to 5 days) ]
    skin condition: color and rash

  8. Fever events outcome, condition of the patient 8 [ Time Frame: During the period of single fever event (up to 5 days) ]
    pulse rate beat per minute

  9. Fever events outcome, condition of the patient 9 [ Time Frame: During the period of single fever event (up to 5 days) ]
    crying quality (no, normal, abnormal)

  10. Fever events outcome, condition of the patient 10 [ Time Frame: During the period of single fever event (up to 5 days) ]
    eating last time in hours

  11. Fever events outcome, condition of the patient 11 [ Time Frame: During the period of single fever event (up to 5 days) ]
    urination painful or smelly (yes - no)

  12. Fever events outcome, condition of the patient 12 [ Time Frame: During the period of single fever event (up to 5 days) ]
    awareness: normal - sleepy - no (subjective scale; minimum = best = normal; maximum = worst = no)

  13. Fever events outcome, condition of the patient 13 [ Time Frame: During the period of single fever event (up to 5 days) ]
    exotic trip in the last 12 month yes - no

  14. Fever events outcome, condition of the patient 14 [ Time Frame: During the period of single fever event (up to 5 days) ]
    seizure yes - no

  15. Fever events outcome, condition of the patient 15 [ Time Frame: During the period of single fever event (up to 5 days) ]
    wry neck yes - no

  16. Fever events outcome, condition of the patient 16 [ Time Frame: During the period of single fever event (up to 5 days) ]
    pain yes - no pain location local - general duration hours

  17. Care-givers state 1 [ Time Frame: 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)

  18. Care-givers state 2 [ Time Frame: 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)

  19. Care-givers state 3 [ Time Frame: 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)

  20. Action taken, evaluation 1 [ Time Frame: 48 hours after illness resolving ]
    Use of medication, use of medical providers service, utility of the device and knowledge base

  21. Action taken, evaluation 2 [ Time Frame: 48 hours after illness resolving ]
    Use of medication no - yes (type and dosage)

  22. Action taken, evaluation 3 [ Time Frame: 48 hours after last fever event documentation ]
    Use of medical providers service no - yes (institution type)

  23. Action taken, evaluation 4 [ Time Frame: 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)


Other Outcome Measures:
  1. Baseline characteristics (profile of patient) 1 [ Time Frame: at registry on the first day ]
    date of birth

  2. Baseline characteristics (profile of patient) 2 [ Time Frame: at registry on the first day ]
    gender: male - female - other

  3. Baseline characteristics (profile) 3 [ Time Frame: at registry on the first day ]
    height centimeter

  4. Baseline characteristics (profile) 4 [ Time Frame: at registry on the first day ]
    weight kilogram

  5. Baseline characteristics (profile) 5 [ Time Frame: at registry on the first day ]
    chronic disease yes - no

  6. Baseline characteristics (profile) 6 [ Time Frame: at registry on the first day ]
    Former use of medication in the last 12 month (antipyretics, antibiotics) yes - no, number

  7. Baseline characteristics (profile) 7 [ Time Frame: 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

  8. Baseline characteristics (profile) 8 [ Time Frame: 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; )



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants are included if they downloaded and registered the mobile application. The use of the application is voluntary. A minimum of 100 individuals are included, a maximum sample size is not specified. Participants are between the age of 0-100. The target population is mainly children (0-18y).
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04633603


Contacts
Layout table for location contacts
Contact: Szőke Henrik, Dr +36 20 4729459 henrik.szoke@etk.pte.hu
Contact: Szőke Rebeka +36202148322 reszoke@gmail.com

Locations
Layout table for location information
Hungary
University of Pecs Recruiting
Pecs, Hungary, 7622
Contact: Szőke Henrik, Dr    +36 20 4729459    henrik.szoke@etk.pte.hu   
Contact: Rebeka Szőke    +36202148322    reszoke@gmail.com   
Sponsors and Collaborators
University of Pecs
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.
Investigators
Layout table for investigator information
Principal Investigator: Szőke Henrik, Dr University of Pecs Faculty of Health Sciences
Additional Information:
Publications of Results:
Other Publications:
Abu-Baker, N.N., Gharaibeh, H.F., Al-Zoubi, H.M., Savage, C., Gharaibeh, M.K., 2013. Mothers' knowledge and practices of managing minor illnesses of children under five years. J. Res. Nurs. 18 (7), 651-666.
Alex-Hart, B.A., Frank-Briggs, A.I., 2011. Mothers' perception of fever management in children. Niger. Health J. 11 (2), 69-72.
Ayatollahi, J., Behjati, M., Shahcheraghi, S.H., 2014. Mothers' knowledge, perception and management of fever in children. Paediatr. Today 1 (1), 14-17.
Fekete Ferenc dr., Láz, ami átlépi az ingerküszöbünket, Gyermekorvos Továbbképzés, 2014. 13. évf. 1. szám
A Nemzeti Erőforrás Minisztérium szakmai protokollja: Lázas gyermekek ellátásáról, Magyar közlöny, 2011

Layout table for additonal information
Responsible Party: University of Pecs
ClinicalTrials.gov Identifier: NCT04633603    
Other Study ID Numbers: IV/209-1/2020/EKU
First Posted: November 18, 2020    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: November 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Pecs:
childhood fever
help-seeking behavior
fever phobia
mobile application
guideline adherence
antipyretics
antibiotics
health literacy
socio-economic assessment
Additional relevant MeSH terms:
Layout table for MeSH terms
Bacterial Infections
Virus Diseases
Fever
Body Temperature Changes