Clinical trial NCT02903342: Fever and Febrile Support for Parents and Carers of Children 2016
Official title: Fever and Febrile Support for Parents and Carers of Children 2016
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fever
Febrile Illness
Keywords: Fever
Febrile illness
Children
Lead sponsor: University College Cork
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Increase in parental knowledge regarding temperature definition for fever
timeFrame: 2 weeks
Secondary outcomes:
measure: Increase in parental knowledge regarding management of fever
timeFrame: 2 weeks
measure: Decrease in parents alternating between antipyretics
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University College Cork
name: Maria Kelly, MPharm, MiM
role: STUDY_DIRECTOR
References:
citation: 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.