Fever and Febrile Support for Parents and Carers of Children 2016

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.

Study Overview

• Status: Completed
• Conditions: Fever; Febrile Illness
• Intervention / Treatment: Other: Leaflet

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Leaflet; A leaflet designed from data obtained from previous qualitative and quantitative studies.
No Intervention: Control; Parents will be asked to complete a survey and re-complete the survey via telephone two weeks later.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increase in parental knowledge regarding temperature definition for fever	Increases in correct parental definition of fever temperature detected using a questionnaire	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increase in parental knowledge regarding management of fever	Increases in correct parental management of fever detected using a questionnaire	2 weeks
Decrease in parents alternating between antipyretics	Decreases in parents alternating between antipyretics to manage fever detected using a questionnaire	2 weeks

Collaborators and Investigators

• Sponsor: University College Cork
• Investigators: Study Director: Maria Kelly, MPharm, MiM, University College Cork

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: August 30, 2016
• First Submitted That Met QC Criteria: September 12, 2016
• First Posted (Estimate): September 16, 2016

Study Record Updates

• Last Update Posted (Estimate): December 19, 2016
• Last Update Submitted That Met QC Criteria: December 16, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Children; Fever; Febrile illness
• Additional Relevant MeSH Terms: Wounds and Injuries; Body Temperature Changes; Heat Stress Disorders; Hyperthermia; Fever
• Other Study ID Numbers: Fever1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO