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

NCT04633603 | Enrolling By Invitation

• 1 other identifier: IV/209-1/2020/EKU
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

childhood fever; help-seeking behavior; fever phobia; mobile application; guideline adherence; antipyretics; antibiotics; health literacy; socio-economic assessment

Outcome Measures

Primary Outcomes (23)

• 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

Other Outcomes (8)

• Baseline characteristics (profile of patient) 1

  at registry on the first day

• Baseline characteristics (profile of patient) 2

  at registry on the first day

• Baseline characteristics (profile) 3

  at registry on the first day

Study Arms (1)

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

Interventions

FeverFriend mobile application DEVICE

Registration, documentation of patients profile, documentation of fever events, following advice regarding the patient and the care-giver, documentation of follow up notifications.

Also known as: FeverFriend web knowledge base (homepage)

All patients

Eligibility Criteria

• Age: Up to 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

Sponsors & Collaborators

• University of Pecs: lead
• Dr. Szőke Henrik és Társa Egészségügyi Szolgáltató Kft.: collaborator
• Hungarian Medical Chamber / Magyar Orvosi Kamara (Győr-Moson-Sopron Megye): collaborator
• University of Witten: collaborator
• Heim Pál Children's Hospital / Heim Pál Országos Gyermekgyógyászati Intézet: collaborator
• Hungarian Emergency Service / Országos Mentőszolgálat: collaborator
• Civil Support Közhasznú Nonprofit Kft.: collaborator

Study Sites (1)

University of Pecs

Pécs, 7622, Hungary

Location

Related Publications (11)

• Purssell E, Collin J. Fever phobia: The impact of time and mortality--a systematic review and meta-analysis. Int J Nurs Stud. 2016 Apr;56:81-9. doi: 10.1016/j.ijnurstu.2015.11.001. Epub 2015 Nov 17.

  PMID: 26643444 BACKGROUND

• Poirier MP, Collins EP, McGuire E. Fever phobia: a survey of caregivers of children seen in a pediatric emergency department. Clin Pediatr (Phila). 2010 Jun;49(6):530-4. doi: 10.1177/0009922809355312. Epub 2010 May 19.

  PMID: 20488812 BACKGROUND

• Sakai R, Okumura A, Marui E, Niijima S, Shimizu T. Does fever phobia cross borders? The case of Japan. Pediatr Int. 2012 Feb;54(1):39-44. doi: 10.1111/j.1442-200X.2011.03449.x. Epub 2011 Oct 30.

  PMID: 21883684 BACKGROUND

• 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.

  BACKGROUND

• Alex-Hart, B.A., Frank-Briggs, A.I., 2011. Mothers' perception of fever management in children. Niger. Health J. 11 (2), 69-72.

  BACKGROUND

• Ayatollahi, J., Behjati, M., Shahcheraghi, S.H., 2014. Mothers' knowledge, perception and management of fever in children. Paediatr. Today 1 (1), 14-17.

  BACKGROUND

• Fekete Ferenc dr., Láz, ami átlépi az ingerküszöbünket, Gyermekorvos Továbbképzés, 2014. 13. évf. 1. szám

  BACKGROUND

• A Nemzeti Erőforrás Minisztérium szakmai protokollja: Lázas gyermekek ellátásáról, Magyar közlöny, 2011

  BACKGROUND

• Section on Clinical Pharmacology and Therapeutics; Committee on Drugs; Sullivan JE, Farrar HC. Fever and antipyretic use in children. Pediatrics. 2011 Mar;127(3):580-7. doi: 10.1542/peds.2010-3852. Epub 2011 Feb 28.

  PMID: 21357332 BACKGROUND

• Rawson TM, Moore LS, Tivey AM, Tsao A, Gilchrist M, Charani E, Holmes AH. Behaviour change interventions to influence antimicrobial prescribing: a cross-sectional analysis of reports from UK state-of-the-art scientific conferences. Antimicrob Resist Infect Control. 2017 Jan 13;6:11. doi: 10.1186/s13756-017-0170-7. eCollection 2017.

  PMID: 28101333 BACKGROUND

• James S, Rao SV, Granger CB. Registry-based randomized clinical trials--a new clinical trial paradigm. Nat Rev Cardiol. 2015 May;12(5):312-6. doi: 10.1038/nrcardio.2015.33. Epub 2015 Mar 17.

  PMID: 25781411 BACKGROUND

Related Links

• Fever under 5s - assessment and initial management, NICE Guideline 2019

MeSH Terms

Conditions

Fever; Anxiety Disorders; Help-Seeking Behavior; Virus Diseases; Bacterial Infections

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Social Behavior; Behavior; Infections; Bacterial Infections and Mycoses

Study Officials

• Szőke Henrik, Dr

  University of Pecs Faculty of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 18, 2020
• Study Start: January 15, 2020
• Primary Completion (Estimated): January 15, 2028
• Study Completion (Estimated): January 15, 2028
• Last Updated: December 12, 2024

Record last verified: 2024-12

Locations

HU (1)