Fever Infants and Therapeutic Education in Emergency Department (D-FI-2)
Primary Purpose
Fever
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Therapeutic education on fever
Therapeutic education on household accidents
Sponsored by
About this trial
This is an interventional prevention trial for Fever
Eligibility Criteria
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
Sites / Locations
- Necker Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Fever therapeutic education session
Control therapeutic education session
Arm Description
Therapeutic education session on fever
Control therapeutic education session (on household accidents)
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
Number of medical consultation unplanned
Number of pediatric emergency consultation
Number of suboptimal care and severe bacterial infection
Full Information
NCT ID
NCT03706599
First Posted
September 28, 2018
Last Updated
October 1, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT03706599
Brief Title
Fever Infants and Therapeutic Education in Emergency Department
Acronym
D-FI-2
Official Title
Fever Infants and Therapeutic Education in Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
September 26, 2018 (Actual)
Primary Completion Date
September 24, 2021 (Actual)
Study Completion Date
September 24, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fever
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fever therapeutic education session
Arm Type
Experimental
Arm Description
Therapeutic education session on fever
Arm Title
Control therapeutic education session
Arm Type
Placebo Comparator
Arm Description
Control therapeutic education session (on household accidents)
Intervention Type
Behavioral
Intervention Name(s)
Therapeutic education on fever
Intervention Description
Session for therapeutique education on fever
Intervention Type
Behavioral
Intervention Name(s)
Therapeutic education on household accidents
Intervention Description
Session for therapeutic education on household accidents
Primary Outcome Measure Information:
Title
Behavior and knowledge score of families obtain through answering D-FI (Decrease Fever Infants) survey
Description
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).
Time Frame
Day 4
Secondary Outcome Measure Information:
Title
Behavior and knowledge of families obtain through answering D-FI (Decrease Fever Infants) survey
Description
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).
Time Frame
6 months
Title
Number of medical consultation unplanned
Time Frame
6 months
Title
Number of pediatric emergency consultation
Time Frame
6 months
Title
Number of suboptimal care and severe bacterial infection
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Angoulvant, MD, PhD
Organizational Affiliation
APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Necker Hospital
City
Paris
ZIP/Postal Code
75015
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Fever Infants and Therapeutic Education in Emergency Department
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