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Fever and Febrile Support for Parents and Carers of Children 2016

NCT ID: NCT02903342

Last Updated: 2016-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2016-08-31

Brief Summary

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To assess the suitability and user-friendliness of an information leaflet for parents on management of fever and febrile illness in children. The purpose of the leaflet is to provide evidence-based information for parents regarding fever and febrile illness in children.

Detailed Description

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The aim of this study is to assess the suitability and user-friendliness of an information leaflet for parents on management of fever and febrile illness in children. The purpose of the leaflet is to provide evidence-based information for parents regarding fever and febrile illness in children. The potential benefit of the leaflet is empowerment parents to take responsibility for monitoring their child's illness, thereby enabling parents to take effective and informed action when required.

The investigators hypothesise that provision of a user friendly information leaflet for parents increases knowledge and provides decision support to guide parents fever management.

This study will investigate the ability of an information leaflet to increase parental knowledge regarding the management of fever and febrile illness in children. Three leaflets were designed. Stakeholders were consulted to select the most appropriate leaflet prior to the beginning of the trial. One leaflet will be used in the trial.

A prospective, multi-centre, randomized, two-parallel arm, controlled trial with blinded outcome ascertainment will be conducted. Three information leaflets were designed based on a previous survey with parents in Ireland. One leaflet was selected for use as the intervention following consultation with stakeholders.

The Primary Objective of the project is to quantify if reading and understanding a leaflet on fever and febrile illness management increases parental knowledge on the subject.

Conditions

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Fever Febrile Illness

Keywords

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Fever Febrile illness Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention

Parents will be asked to read a leaflet. They will then complete a survey and re-complete the survey via telephone two weeks later.

Group Type EXPERIMENTAL

Leaflet

Intervention Type OTHER

A leaflet designed from data obtained from previous qualitative and quantitative studies.

Control

Parents will be asked to complete a survey and re-complete the survey via telephone two weeks later.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Leaflet

A leaflet designed from data obtained from previous qualitative and quantitative studies.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Parents with at least one child aged five years of age or younger at the time of recruitment.
* Parents of healthy children.

Exclusion Criteria

* Parents who did not have at least one child aged five years of age or younger at the time of recruitment.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University College Cork

OTHER

Sponsor Role lead

Responsible Party

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Maria Kelly

Research Pharmacist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria Kelly, MPharm, MiM

Role: STUDY_DIRECTOR

University College Cork

References

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Kelly M, Sahm L, McCarthy S, O'Sullivan R, Mc Gillicuddy A, Shiely F. Randomised controlled trial of an intervention to improve parental knowledge and management practices of fever. BMC Pediatr. 2019 Nov 19;19(1):447. doi: 10.1186/s12887-019-1808-9.

Reference Type DERIVED
PMID: 31739785 (View on PubMed)

Other Identifiers

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Fever1

Identifier Type: -

Identifier Source: org_study_id