Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03706599 |
| Other study ID # |
K170306J / AOR12065 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 26, 2018 |
| Est. completion date |
September 24, 2021 |
Study information
| Verified date |
October 2021 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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
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.
