NCT02903342

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

August 30, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 16, 2016

Completed
Last Updated

December 19, 2016

Status Verified

December 1, 2016

Enrollment Period

2 months

First QC Date

August 30, 2016

Last Update Submit

December 16, 2016

Conditions

FeverFebrile Illness

Keywords

FeverFebrile illnessChildren

Outcome Measures

Primary Outcomes (1)

  • Increase in parental knowledge regarding temperature definition for fever

    Increases in correct parental definition of fever temperature detected using a questionnaire

    2 weeks

Secondary Outcomes (2)

  • Increase in parental knowledge regarding management of fever

    2 weeks

  • Decrease in parents alternating between antipyretics

    2 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

LeafletOTHER

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

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 31739785DERIVED

MeSH Terms

Conditions

Fever

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Maria Kelly, MPharm, MiM

    University College Cork

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Pharmacist

Study Record Dates

First Submitted

August 30, 2016

First Posted

September 16, 2016

Study Start

June 1, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

December 19, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share