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

October 1, 2021 updated by: Assistance Publique - Hôpitaux de Paris
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
92

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • Necker Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Behavior and knowledge score of families obtain through answering D-FI (Decrease Fever Infants) survey
Time Frame: Day 4
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Behavior and knowledge of families obtain through answering D-FI (Decrease Fever Infants) survey
Time Frame: 6 months
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
Time Frame: 6 months
6 months
Number of pediatric emergency consultation
Time Frame: 6 months
6 months
Number of suboptimal care and severe bacterial infection
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: François Angoulvant, MD, PhD, APHP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 26, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 24, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 24, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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