Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000224628
Ethics application status
Approved
Date submitted
22/02/2023
Date registered
2/03/2023
Date last updated
10/04/2024
Date data sharing statement initially provided
2/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The Readability Study: A randomised trial to examine the effect of health information written at different grade reading levels.
Scientific title
The Readability Study: A randomised trial to examine the effect of health information written at different grade reading levels on knowledge, perceived reading ease and acceptability in healthy adults.
Secondary ID [1] 308936 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
health literacy 328943 0
Condition category
Condition code
Public Health 325931 325931 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to read two pieces of health information about sciatica and knee osteoarthritis written at one of four grade reading levels: 8, 10, 12 and 14. The texts are approximately 350 words each. We expect the entire questionnaire to take 15 minutes, with 2 minutes to be spent on each text. To reduce the chance of participants skipping through the questions without reading the intervention text, participants will not be able to move onto the next questions until 1 minute has passed (to be confirmed through piloting).

The original text was sourced from UpToDate Patient Education Materials (Beyond the Basics). The text was adapted slightly to meet a grade reading level of 14, and to ensure it clearly covered all items in the knowledge measure. The text was then simplified and revised down iteratively to grade 12, 10 and 8.
Intervention code [1] 325380 0
Treatment: Other
Comparator / control treatment
Health information about knee osteoarthritis and sciatica written at a grade 14 reading level. This text is about 350 words adapted from UpToDate Patient Education Material (Beyond the Basics). Approximate duration is 2 minutes per text. The entire questionnaire will likely take 15 minutes to complete.
Control group
Active

Outcomes
Primary outcome [1] 333776 0
Knowledge: Two 7-point scales for each topic. Combination of 4 validated and 3 purpose-built MCQ knowledge items. Each item scored correct (1) or incorrect (0). Knowledge scores for each topic to be summed, with the final score to be out of 14.
Timepoint [1] 333776 0
Immediately after exposure
Secondary outcome [1] 418269 0
Perceived reading ease

7-point Likert scale (1 = ‘very easy’ to 7 = ‘very difficult’)
‘How easy or difficult did you find this information to read?’
7-point Likert scale (1 = ‘straightforward’ to 7 = ‘confusing’)
‘How straightforward or confusing did you find this information?’
Timepoint [1] 418269 0
Immediately after exposure
Secondary outcome [2] 418270 0
Acceptability

5-point scale (1= strongly agree, 7 = ‘strongly disagree’)
“If I was looking for information about [sciatica or degenerative knee disease] this information would have been useful”

5-point scale (1= strongly agree, 7 = ‘strongly disagree’)
“I would give this information to my friend if they wanted to know more about [sciatica or degenerative knee disease’
Timepoint [2] 418270 0
Immediately after exposure
Secondary outcome [3] 418870 0
Trustworthiness of information measured on a 10 point scale, 1 = not at all trustworthy, 10= very trustworthy
Timepoint [3] 418870 0
Immediately after exposure
Secondary outcome [4] 433855 0
Knowledge (validated). 4 MCQ items for each topic. Total score summed across the two topics to give a final score out of 8.
Timepoint [4] 433855 0
Immediately after exposure.

Eligibility
Key inclusion criteria
Aged 18 years and older
Living in Australia
Adequate understanding of English to be able to complete the questionnaire and give informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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)
Randomisation will be achieved through Qualtrics survey software
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be achieved through Qualtrics survey software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
We will test for overall differences between randomised conditions using linear regression models / ANOVA. Planned simple contrasts will also be conducted to test where the differences lie between the conditions. Analysis of pilot data will be used to obtain mean and standard deviation of the knowledge measure which will inform the final sample size calculation.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/04/2023
Actual
18/04/2023
Date of last participant enrolment
Anticipated
30/04/2023
Actual
13/09/2023
Date of last data collection
Anticipated
30/04/2023
Actual
13/09/2023
Sample size
Target
2200
Accrual to date
Final
2235
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313145 0
Government body
Name [1] 313145 0
National Health and Medical Research Council
Country [1] 313145 0
Australia
Primary sponsor type
University
Name
School of Public Health, University of Sydney
Address
Edward Ford Building (A27)
The University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 314849 0
None
Name [1] 314849 0
Address [1] 314849 0
Country [1] 314849 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312388 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 312388 0
Ethics committee country [1] 312388 0
Australia
Date submitted for ethics approval [1] 312388 0
13/02/2023
Approval date [1] 312388 0
05/04/2023
Ethics approval number [1] 312388 0
HREC Protocol No: [2023/188]

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

Contacts
Principal investigator
Name 124486 0
Prof Kirsten McCaffery
Address 124486 0
Room 128B
Edward Ford Building (A27)
The University of Sydney
NSW, 2006
Country 124486 0
Australia
Phone 124486 0
+61293517220
Fax 124486 0
Email 124486 0
[email protected]
Contact person for public queries
Name 124487 0
Olivia Mac
Address 124487 0
Room 128C
Edward Ford Building (A27)
The University of Sydney
NSW, 2006
Country 124487 0
Australia
Phone 124487 0
+61 452574851
Fax 124487 0
Email 124487 0
[email protected]
Contact person for scientific queries
Name 124488 0
Olivia Mac
Address 124488 0
Room 128C
Edward Ford Building (A27)
The University of Sydney
NSW, 2006
Country 124488 0
Australia
Phone 124488 0
+61 452574851
Fax 124488 0
Email 124488 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All individual participant data collected during the trial can be made available in de-identified csv or excel datasets, along with the data dictionary.
When will data be available (start and end dates)?
Data will be made available once the manuscript outlining results from the study has been published. No end date determined.
Available to whom?
Data will be made available upon request to anyone wishing to access it who provides a methodologically sound proposal to the principal investigator.
Available for what types of analyses?
Replication and meta-analyses
How or where can data be obtained?
Data will be made available upon direct contact with the principal investigator. Contact details of the principal investigator are: [email protected]


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.