Fever and Febrile Support for Parents and Carers of Children 2016
Primary Purpose
Fever, Febrile Illness
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Leaflet
Sponsored by
About this trial
This is an interventional health services research trial for Fever focused on measuring Fever, Febrile illness, Children
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Parents will be asked to read a leaflet. They will then complete a survey and re-complete the survey via telephone two weeks later.
Parents will be asked to complete a survey and re-complete the survey via telephone two weeks later.
Outcomes
Primary Outcome Measures
Increase in parental knowledge regarding temperature definition for fever
Increases in correct parental definition of fever temperature detected using a questionnaire
Secondary Outcome Measures
Increase in parental knowledge regarding management of fever
Increases in correct parental management of fever detected using a questionnaire
Decrease in parents alternating between antipyretics
Decreases in parents alternating between antipyretics to manage fever detected using a questionnaire
Full Information
NCT ID
NCT02903342
First Posted
August 30, 2016
Last Updated
December 16, 2016
Sponsor
University College Cork
1. Study Identification
Unique Protocol Identification Number
NCT02903342
Brief Title
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
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College Cork
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fever, Febrile Illness
Keywords
Fever, Febrile illness, Children
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Parents will be asked to read a leaflet. They will then complete a survey and re-complete the survey via telephone two weeks later.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Parents will be asked to complete a survey and re-complete the survey via telephone two weeks later.
Intervention Type
Other
Intervention Name(s)
Leaflet
Intervention Description
A leaflet designed from data obtained from previous qualitative and quantitative studies.
Primary Outcome Measure Information:
Title
Increase in parental knowledge regarding temperature definition for fever
Description
Increases in correct parental definition of fever temperature detected using a questionnaire
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Increase in parental knowledge regarding management of fever
Description
Increases in correct parental management of fever detected using a questionnaire
Time Frame
2 weeks
Title
Decrease in parents alternating between antipyretics
Description
Decreases in parents alternating between antipyretics to manage fever detected using a questionnaire
Time Frame
2 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Kelly, MPharm, MiM
Organizational Affiliation
University College Cork
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31739785
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.
Results Reference
derived
Learn more about this trial
Fever and Febrile Support for Parents and Carers of Children 2016
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