Fever Infants and Therapeutic Education in Emergency Department (D-FI-2)

To evaluate the effect of a therapeutic education session on fever versus a control education session on household accidents on the behavior and knowledge of families concerning the management of infant fever between day 4 and day 7 after the intervention

Study Overview

• Status: Completed
• Conditions: Fever
• Intervention / Treatment: Behavioral: Therapeutic education on fever; Behavioral: Therapeutic education on household accidents

Detailed Description

Increased attendance at pediatric emergencies is observed in many countries. Fever, a frequent reason for consultation in pediatric emergencies, contributes to this phenomenon and is known to cause panic reactions in parents that are not justified by the actual state of the child. The accurate identification of families' lack of knowledge of fever has allowed us to develop a therapeutic education session, after which families should be able to properly care for a febrile child without excessive use of emergency services.

The hypothesis is that a therapeutic education session on fever in infancy, intended for parents, carried out in pediatric emergencies, after a consultation for febrile illness will allow:

• improve family behaviors and knowledge regarding fever in children.
• limit the number of new consultations to pediatric emergencies in the next 6 months.

The project takes place in two successive phases.

1. First phase, which is now completed, consisted of 4 stages:

   A. Semi-structured interviews conducted by an anthropologist with parents of children aged 3 months to 2 years who consulted pediatric emergencies for the reason "fever". The anthropologist questioned the families about their perceptions of the fever, the perceived origin, the fears associated with this symptom, the behavior adopted, the reasons for the consultation in these services:

   B. Development of a therapeutic education session for fever. This session was conceived from the data of the literature but also from the results of the semi-directive interviews, in particular to better correspond to the sociocultural characteristics of the families consulting in pediatric emergencies.

   C. Elaboration of a questionnaire to evaluate behaviors and knowledge, called "D-FI" questionnaire: the thematic cross-sectional analysis of the interviews led to the construction of a knowledge assessment questionnaire on the management of fever in infants by families. This questionnaire will assess the effectiveness of the therapeutic education intervention.

   D. Validation of the D-Fi questionnaire in a test population: the questionnaire was administered to "uneducated" parents in the management of fever and to health professionals. The results between these two groups were compared. Different aspects have been studied:

   • Reliability of the questionnaire.
   • Quality of each selected item
   • Internal validity
   • Calculation of a score to assess skills and knowledge on fever
2. The study reported at Clinical trial corresponds to the second phase of this project.

A randomized controlled trial will evaluate the impact of the therapeutic education session developed in Phase 1 on family behaviors and knowledge on fever compared to a control intervention. The intervention control will be a health education session on the prevention of domestic accidents. The D-Fi survey designed during the first phase will be used during this test. The recruitment of consulting patients in two different hospitals, namely the hospitals of Robert-Debré (Paris 19th) and Necker-Enfants Malades (Paris 15th), will widen the socio-cultural diversity of the population included in this project and improve the external validity of the study.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • Necker Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 2 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Francophone family who consults for a febrile illness of their child (defined by a t °> 38 °) aged from 3 months to 2 years at the time of passage to pediatric emergencies Presence of at least one parent or guardian of the child

Exclusion Criteria:

• Presence of chronic pathology Family already included in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Fever therapeutic education session; Therapeutic education session on fever	Behavioral: Therapeutic education on fever; Session for therapeutique education on fever
PLACEBO_COMPARATOR: Control therapeutic education session; Control therapeutic education session (on household accidents)	Behavioral: Therapeutic education on household accidents; Session for therapeutic education on household accidents

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavior and knowledge score of families obtain through answering D-FI (Decrease Fever Infants) survey	score D-FI survey :D-FI survey is a scale measuring behavior and knowledge of families on fever. Range from 0 (low score) to 10 (high score=better knowledge and behavior).	Day 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavior and knowledge of families obtain through answering D-FI (Decrease Fever Infants) survey	score D-FI survey :D-FI survey is a scale measuring behavior and knowledge of families on fever. Range from 0 (low score) to 10 (high score=better knowledge and behavior).	6 months
Number of medical consultation unplanned		6 months
Number of pediatric emergency consultation		6 months
Number of suboptimal care and severe bacterial infection		6 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: François Angoulvant, MD, PhD, APHP

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 26, 2018
• Primary Completion (ACTUAL): September 24, 2021
• Study Completion (ACTUAL): September 24, 2021

Study Registration Dates

• First Submitted: September 28, 2018
• First Submitted That Met QC Criteria: October 10, 2018
• First Posted (ACTUAL): October 16, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 4, 2021
• Last Update Submitted That Met QC Criteria: October 1, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Body Temperature Changes; Emergencies; Fever
• Other Study ID Numbers: K170306J / AOR12065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No