Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001057875
Ethics application status
Approved
Date submitted
27/09/2012
Date registered
4/10/2012
Date last updated
4/10/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of a fever management education program for parents with low health literacy. A Randomised Control Trial (RCT)
Scientific title
In parents with low health literacy how effective is a fever management education program in improving their child fever management and fever health knowledge
Secondary ID [1] 281210 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Child fever Management 287398 0
Child fever knowledge 287527 0
Condition category
Condition code
Public Health 287729 287729 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group one: This group will involve parents with low health literacy who will receive a fever education package designed for low health literacy people. The education package includes an eight minute DVD and brochure; both the DVD and the brochure will contain information about pharmacological and non-pharmacological fever treatments, the correct way of measuring a child’s body temperature, and general knowledge about fever.

Intervention group two: this group will involve parents with functional health literacy who will also receive the same fever education package received by the first group.
Intervention code [1] 285677 0
Other interventions
Comparator / control treatment
Control group one: this group will involve parents with low health literacy who will not receive the study intervention until the completion of the trial (3 months post recruitment). The study intervention (DVD and brochure) will be sent to all control participants after the last post questionnaire has been mailed (3 months post recruitment). They will receive at recruitment the existing hospital fever brochure that is provided to parents. The hospital brochure contains the following information: definition of fever, causes of fever, when do you need to see a doctor for a febrile? What can you do at home with a febrile child?


Control group two: this group will involve parents with functional health literacy who will not receive the study intervention until the completion of the trial (3 months post recruitment as in control group 1). They will receive at recruitment the existing hospital fever brochure that is provided to parents.
Control group
Active

Outcomes
Primary outcome [1] 287969 0
Participants General fever health knowledge
Timepoint [1] 287969 0
To assess this outcome a pre test and a post test questionnaire (after three months interval) will be administered to participants in both control and intervention groups to assess any improvement in their fever health knowledge.
Survey instruments (questionnaire) have been adopted from a published and validated questionnaire on parental knowledge and management of fever in children (Matziou et al., 2008; Sakai et al., 2009; Sarrell & Kahan, 2003; Walsh et al., 2008)
Primary outcome [2] 287970 0
Participant's fever management practice
Timepoint [2] 287970 0
To assess this outcome a pre test and a post test questionnaire (after three months interval) will be administered to participants in both control and intervention groups to assess their improvement in their fever management practice.

The post survey instruments (questionnaire) have been adopted from a published and validated questionnaire on parental knowledge and management of fever in children (Matziou et al., 2008; Sakai et al., 2009; Sarrell & Kahan, 2003; Walsh et al., 2008)
Secondary outcome [1] 299161 0
Reduction in unnecessarily febrile child presentation to ED
Timepoint [1] 299161 0
To assess this outcome the hospital records will be accessed and reviewed three months after conducting the study.

Eligibility
Key inclusion criteria
1. Parents of Children with a history of fever before presentation to ED or with a temperature of greater than 37 degrees

2. Parents of Children aged between three months to five years

3. Parents who are able to read, write and understand English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Parents of children younger than three months, older than five years.

2. Any child located in the Resuscitation area

3. Parents who cannot speak, read and write in English

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Initially participants will be screened by a Research Assistant (RA) for eligibility through an intranet database called FIRSTNET available in the ED at the hospital. The RA then will approach the parents and ask them if they would be interested in participating in the study. The RA will then explain the project and the aim of the study. The participant information sheet will then be provided and written consent will be obtained from interested participants.

The RA will then complete the health literacy assessment with the participant and then give them the pre questionnaire form to complete while they are in the ED. The participant will also be asked for their contact details in order to send them the follow up post survey in three months.

Group allocation will be represented by serielly numbered opaque envelopes that will be generated by block randomisation stratified according to the level of health literacy (Low vs functional). Depending on the group allocation envelopes will contain either the study intervention (Low health literacy education program) or the existing hospital fever brochure that is provided to parents in the ED. Based on the health literacy assessments the RA will provide participants with the relevant envelopes. The RA will be unaware of the group allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be allocated to the groups using block randomisation stratified according to the level of health literacy. A computer generated random number sequence will be used to chose the blocks and set the allocation order of the particpants. Block randomisation will ensure the number of particpants in each arm of the trial will be evenly balanced.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
18/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
324
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286003 0
Commercial sector/Industry
Name [1] 286003 0
Reckitt Benckiser (Australia) Pty Ltd
Country [1] 286003 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Centre for Applied Nursing Research. South Western Sydney Local Health District/ University of Western Sydney
Address
Locked Bag 7103
Liverpool BC
NSW 1871
Country
Australia
Secondary sponsor category [1] 284821 0
None
Name [1] 284821 0
Address [1] 284821 0
Country [1] 284821 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288038 0
South Western Sydney Local Health District
Ethics committee address [1] 288038 0
Ethics committee country [1] 288038 0
Australia
Date submitted for ethics approval [1] 288038 0
01/07/2011
Approval date [1] 288038 0
05/12/2011
Ethics approval number [1] 288038 0
HREC/11/LPOOL/265
Project no 11/169

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34698 0
Address 34698 0
Country 34698 0
Phone 34698 0
Fax 34698 0
Email 34698 0
Contact person for public queries
Name 17945 0
Muhammad Alqudah
Address 17945 0
Centre for Applied Nursing Research
Locked Bag 7103
liverpool BC
NSW 1871
Country 17945 0
Australia
Phone 17945 0
+61 2 87389351
Fax 17945 0
Email 17945 0
[email protected]
Contact person for scientific queries
Name 8873 0
Muhammad Alqudah
Address 8873 0
Centre for Applied Nursing Research
Locked Bag 7103
liverpool BC
NSW 1871
Country 8873 0
Australia
Phone 8873 0
+61 2 87389351
Fax 8873 0
Email 8873 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.