FeverNCT02903342
Fever and Febrile Support for Parents and Carers of Children 2016
A study testing Leaflet in people with Fever and Febrile Illness, run by University College Cork.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Fever, Febrile Illness
- What is being tested?
- Leaflet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parents with at least one child aged five years of age or younger at the time of recruitment.
- Parents of healthy children.
Who cannot join
- Parents who did not have at least one child aged five years of age or younger at the time of recruitment.
About this study
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.
Read the 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.
- Conditions
- Fever, Febrile Illness
- Being tested
- Leaflet
- Keywords
- Fever, Febrile illness, Children
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeafletOther
A leaflet designed from data obtained from previous qualitative and quantitative studies.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Leaflet |
| Control | No intervention | Parents will be asked to complete a survey and re-complete the survey via telephone two weeks later. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in parental knowledge regarding temperature definition for fever
Increases in correct parental definition of fever temperature detected using a questionnaire
Measured: 2 weeks
Secondary outcomes (2)
Increase in parental knowledge regarding management of fever
Increases in correct parental management of fever detected using a questionnaire
Measured: 2 weeks
Decrease in parents alternating between antipyretics
Decreases in parents alternating between antipyretics to manage fever detected using a questionnaire
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startJun 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Kelly, University College Cork
- Investigators
- Maria Kelly, MPharm, MiM, Study director, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02903342
- Sponsor's protocol ID
- Fever1
- Status last verified
- Dec 2016
- First submitted
- 30 Aug 2016
- Last updated
- 19 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 31739785
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fever and Febrile Support for Parents and Carers of Children 2016
- ClinicalTrials.gov ID
- NCT02903342
- Acronym / sponsor ID
- Fever1
- Conditions
- Fever, Febrile Illness
- Keywords
- Fever, Febrile illness, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 16 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: LeafletParents will be asked to read a leaflet. They will then complete a survey and re-complete the survey via telephone two weeks later. |
| Control | No intervention | –Parents will be asked to complete a survey and re-complete the survey via telephone two weeks later. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Parents with at least one child aged five years of age or younger at the time of recruitment.
- Parents of healthy children.
Key exclusion criteria (1 listed)
- Parents who did not have at least one child aged five years of age or younger at the time of recruitment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LeafletA leaflet designed from data obtained from previous qualitative and quantitative studies. | Other | Intervention |
Primary outcome
Increase in parental knowledge regarding temperature definition for fever
Time frame: 2 weeks
Increases in correct parental definition of fever temperature detected using a questionnaire
2 secondary outcomes
Increase in parental knowledge regarding management of fever
Time frame: 2 weeks
Decrease in parents alternating between antipyretics
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2016.
- Derived from this study: PubMed 31739785Kelly 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Kelly, MPharm, MiM study director
University College Cork
Questions about this trial
What is this clinical trial studying?
A study testing Leaflet in people with Fever and Febrile Illness, run by University College Cork.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in parental knowledge regarding temperature definition for fever (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02903342, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2016.