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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
University College Cork
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Fever focused on measuring Fever, Febrile illness, Children

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    August 30, 2016
    Last Updated
    December 16, 2016
    Sponsor
    University College Cork
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    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

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