Fever and Febrile Support for Parents and Carers of Children 2016

Fever Clinical Trial

Official title:

Fever and Febrile Support for Parents and Carers of Children 2016

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02903342
• Other study ID #: Fever1
• Status: Completed
• Phase: N/A
• First received: August 30, 2016
• Last updated: December 16, 2016
• Start date: June 2016
• Est. completion date: August 2016

Study information

• Verified date: December 2016
• Source: University College Cork
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Febrile Illness
• Fever

Intervention

Other:
• Leaflet
A leaflet designed from data obtained from previous qualitative and quantitative studies.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University College Cork

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in parental knowledge regarding temperature definition for fever	Increases in correct parental definition of fever temperature detected using a questionnaire	2 weeks	No
Secondary	Increase in parental knowledge regarding management of fever	Increases in correct parental management of fever detected using a questionnaire	2 weeks	No
Secondary	Decrease in parents alternating between antipyretics	Decreases in parents alternating between antipyretics to manage fever detected using a questionnaire	2 weeks	No