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临床试验/NCT04633603
NCT04633603Enrolling By Invitation不适用

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

University of Pecs1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2020年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
10,000
试验地点
1
主要终点
Action taken, evaluation 2

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Action taken, evaluation 2

时间窗: 48 hours after illness resolving

Use of medication no - yes (type and dosage)

Fever events outcome, condition of the patient 4

时间窗: During the period of single fever event (up to 5 days)

hydration: normal - somewhat decreased - severely decreased

Fever events outcome, condition of the patient 9

时间窗: During the period of single fever event (up to 5 days)

crying quality (no, normal, abnormal)

Fever events outcome, condition of the patient 1

时间窗: During the period of single fever event (up to 5 days)

body temperature grade Celsius

Fever events outcome, condition of the patient 3

时间窗: 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 14

时间窗: During the period of single fever event (up to 5 days)

seizure yes - no

Fever events outcome, condition of the patient 12

时间窗: 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 2

时间窗: During the period of single fever event (up to 5 days)

duration of fever in days

Fever events outcome, condition of the patient 7

时间窗: During the period of single fever event (up to 5 days)

skin condition: color and rash

Fever events outcome, condition of the patient 13

时间窗: 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 11

时间窗: During the period of single fever event (up to 5 days)

urination painful or smelly (yes - no)

Fever events outcome, condition of the patient 5

时间窗: During the period of single fever event (up to 5 days)

ventilation: rate per minute

Fever events outcome, condition of the patient 6

时间窗: 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 8

时间窗: During the period of single fever event (up to 5 days)

pulse rate beat per minute

Fever events outcome, condition of the patient 15

时间窗: During the period of single fever event (up to 5 days)

wry neck yes - no

Care-givers state 1

时间窗: 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)

Action taken, evaluation 1

时间窗: 48 hours after illness resolving

Use of medication, use of medical providers service, utility of the device and knowledge base

Fever events outcome, condition of the patient 10

时间窗: During the period of single fever event (up to 5 days)

eating last time in hours

Fever events outcome, condition of the patient 16

时间窗: During the period of single fever event (up to 5 days)

pain yes - no pain location local - general duration hours

Action taken, evaluation 3

时间窗: 48 hours after last fever event documentation

Use of medical providers service no - yes (institution type)

Action taken, evaluation 4

时间窗: 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)

Care-givers state 2

时间窗: 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

时间窗: 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)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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