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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02903342
Other study ID # Fever1
Secondary ID
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


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
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