NCT04656444

Brief Summary

Novel Coronavirus disease 2019 (COVID-19) outbreak seriously challenges worldwide health care systems. The current climate of anxiety due to COVID-19 and home confinement limiting access to emergency departments (ED) have induced an increase of phone calls to the emergency call center "15" medical advices. To determine if a pediatric telephone triage protocol may improve patient's pathways during COVID-19 outbreak, parental compliance is assessed after telephone advice, during and after home confinement (the end of home confinement in France was on May 11th 2020). From 14th April 2020 to 7th June 2020, all calls received by the platform of telephone calls at Children's Lenval Hospital during open hours and open days are collected. For each call, symptoms are recorded by trained physicians and trained residents using a telephonic triage tool through a directed interview. A medical orientation is recommended to parents at the end of their call. Follow-up are conducted 2 to 4 days after with their consent by telephone interview in order to evaluate their compliance

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 7, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

July 19, 2021

Status Verified

February 1, 2021

Enrollment Period

3 months

First QC Date

December 4, 2020

Last Update Submit

July 13, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • parental compliance

    Compliance will be assessed by comparing the path defined by the doctor during the phone call and the orientation actually decided by the parents within 24 hours of the first phone call.

    at 24 hours post inclusion

Secondary Outcomes (1)

  • parental anxiety

    at 24 hours post inclusion

Study Arms (1)

phone call to emergency department

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

patients calling the emergency department during working hours and days: Monday to Friday from 8:30 a.m. to 6:30 p.m. and Saturday morning between 8:30 a.m. and 12:30 p.m.

You may qualify if:

  • Calls received by the platform of telephone calls at Children's Lenval Hospital on working days during working hours: Monday to Friday, 08h30-18h30, and Saturday 08h30-12h30

You may not qualify if:

  • Calls received during the weekends or holidays. Calls received outside working hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpitaux Pédiatrique de Nice CHU Lenval

Nice, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
4 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2020

First Posted

December 7, 2020

Study Start

July 1, 2021

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

July 19, 2021

Record last verified: 2021-02

Locations