Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000386639
Ethics application status
Approved
Date submitted
30/03/2023
Date registered
17/04/2023
Date last updated
4/04/2024
Date data sharing statement initially provided
17/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
CheckMyText! Randomised controlled trial to evaluate the SHeLL Health Literacy Editor
Scientific title
Randomised controlled trial to evaluating the effect of Australian health information providers' and health students' use of the SHeLL Health Literacy Editor on health literacy of written health information
Secondary ID [1] 308909 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
lack of health literacy 329554 0
Condition category
Condition code
Public Health 326485 326485 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will have access to the Editor (https://shell.techlab.works/ ) and self-directed training materials. The Editor is an online browser-based tool that helps users develop text-based health education materials that adhere to health literacy guidelines. The Editor comprises six assessments: readability, complex language, passive voice, text structure, lexical density and diversity, and person-centred language. These are each presented as global scores, with additional, more specific feedback flagged in the text itself. Several training resources embedded within the intervention include:
1. Help page: The Editor’s help page containing instructions, video tutorials and worked examples
2. Self-check tool: 5 questions to check understanding of key concepts (available from the help page)
3. Quick start guide: A 2-page PDF introducing key concepts (available from the help page)

Participants in this group will also be invited to take part in a 30-minute Zoom call administered by a member of the research team. Participants will be introduced to the tool and any relevant training resources, with opportunity to ask questions. If participants are not able to make the Zoom meeting they will have access to a recording of the same content. Zoom attendance / evidence of viewing of the recording will be used to monitor adherence to the intervention.

After completing training, participants in the intervention group will be sent a link to the text revision task. They will receive reminders at 1 and 2 weeks if the task has not been completed.

During the text revision task, participants are provided with the following instructions: Your task is to revise each of the texts below so that they are easy for most people to understand. Try to:
• make the text simpler (aim for Grade 8 to 10)
• make sure that the take-home messages stay the same.
Participants are asked to set aside 40 minutes for this part of the study.

Participants in the intervention group are also instructed to use the Editor to help them revise the text.

As stated in the outcomes, participants in the intervention group will also be asked to self-report which features they used within the Editor (e.g. readability, complex language, passive voice)
Intervention code [1] 325354 0
Treatment: Other
Comparator / control treatment
Participants will be asked to use their usual processes to revise the text. No training is provided prior to the task revision task. Examples of usual processes include revising text based on Microsoft Word grade reading score, only readability calculators, and using thesauri to identify simpler alternatives.

Participants in the control group will be sent a link to the text revision task. They will receive reminders at 1 and 2 weeks if the task has not been completed.

During the text revision task, participants are provided with the following instructions: Your task is to revise each of the texts below so that they are easy for most people to understand. Try to:
• make the text simpler (aim for Grade 8 to 10)
• make sure that the take-home messages stay the same.
Participants are asked to set aside 40 minutes for this part of the study.
Control group
Active

Outcomes
Primary outcome [1] 334328 0
Grade readings score (Simple Measure of Gobbledygook).
Timepoint [1] 334328 0
Participants are asked to complete the revision task within the week after completing the training.
Secondary outcome [1] 420255 0
Text accuracy / retention of meaning: Two researchers will assess each text for retention of key messages (determined a-priori), and identify any additional or incorrect information.
Timepoint [1] 420255 0
Participants are asked to complete the revision task within the week after completing the training.
Secondary outcome [2] 420256 0
Text Complexity: The Editor’s text complexity score reports the proportion (as a %) of words in the text being assessed that are flagged by the program as ‘complex.’ This includes acronyms, any words for which a simpler alternative has been identified, based on public health and medical thesauruses, and any words that are flagged as ‘uncommon’ in English, according to a database of more than 270 million words.
Timepoint [2] 420256 0
Participants are asked to complete the revision task within the week after completing the training.
Secondary outcome [3] 420257 0
Passive voice: The Editor’s passive voice score indicates the number of passive voice in the text.
Timepoint [3] 420257 0
Participants are asked to complete the revision task within the week after completing the training.
Secondary outcome [4] 420258 0
Expert Patient Education Materials Assessment Tool (PEMAT) assessment: Two co-investigators will assess each revised text, masked to intervention group. Relevant PEMAT #1 is: The text makes its purpose completely evident Relevant reference : S.J. Shoemaker, M.S. Wolf, C. Brach, Development of the Patient Education Materials Assessment Tool (PEMAT): a new measure of understandability and actionability for print and audiovisual patient information, Patient Educ Couns 96(3) (2014) 395-403. PMID:24973195.
Timepoint [4] 420258 0
Participants are asked to complete the revision task within the week after completing the training.
Secondary outcome [5] 420267 0
Items were adapted to ask participants which of two texts (original + revised) they preferred e.g. Which text would you be more likely to share with family and friends?
Timepoint [5] 420267 0
This assessment is conducted separately to the trial (i.e. with separate participants). Assessments will take place immediately after reviewing the revised health information.
Secondary outcome [6] 420268 0
self-reported time to complete the task (minutes), collected via online survey
Timepoint [6] 420268 0
Participants are asked to complete the revision task within the week after completing the training.
Secondary outcome [7] 420269 0
Usability: assessed by the System Usability Scale, and The System Usability Scale produces a score from 0 (low) to 100 (high).
Timepoint [7] 420269 0
Participants are asked to complete the revision task within the week after completing the training.
Secondary outcome [8] 420270 0
Acceptability: the Technology Acceptance Model (comprises two subscales: perceived usefulness and perceived ease of use). Each subscale produces a score ranging from 1 (low) to 7 (high). Scores are predictive of current and future use of a product.
Timepoint [8] 420270 0
Participants are asked to complete the revision task within the week after completing the training.
Secondary outcome [9] 420271 0
Engagement and fidelity: Self-reported Health Literacy Editor training resources accessed and features within the tool used when revising the text, collected via online survey
Timepoint [9] 420271 0
Participants are asked to complete the revision task after completing the training.
Secondary outcome [10] 420621 0
Expert Patient Education Materials Assessment Tool (PEMAT) assessment: Two co-investigators will assess each revised text, masked to intervention group. Relevant PEMAT #2 is: The text has no distracting information or content Relevant reference : S.J. Shoemaker, M.S. Wolf, C. Brach, Development of the Patient Education Materials Assessment Tool (PEMAT): a new measure of understandability and actionability for print and audiovisual patient information, Patient Educ Couns 96(3) (2014) 395-403. PMID:24973195.
Timepoint [10] 420621 0
Participants are asked to complete the revision task within the week after completing the training.
Secondary outcome [11] 420622 0
Expert Patient Education Materials Assessment Tool (PEMAT) assessment: Two co-investigators will assess each revised text, masked to intervention group. Relevant PEMAT #3 is: The text uses common, everyday language Relevant reference : S.J. Shoemaker, M.S. Wolf, C. Brach, Development of the Patient Education Materials Assessment Tool (PEMAT): a new measure of understandability and actionability for print and audiovisual patient information, Patient Educ Couns 96(3) (2014) 395-403. PMID:24973195.
Timepoint [11] 420622 0
Participants are asked to complete the revision task within the week after completing the training.
Secondary outcome [12] 420623 0
Expert Patient Education Materials Assessment Tool (PEMAT) assessment: Two co-investigators will assess each revised text, masked to intervention group. Relevant PEMAT #4 is: The text defines medical terms Relevant reference : S.J. Shoemaker, M.S. Wolf, C. Brach, Development of the Patient Education Materials Assessment Tool (PEMAT): a new measure of understandability and actionability for print and audiovisual patient information, Patient Educ Couns 96(3) (2014) 395-403. PMID:24973195.
Timepoint [12] 420623 0
Participants are asked to complete the revision task within the week after completing the training.
Secondary outcome [13] 420624 0
Expert Patient Education Materials Assessment Tool (PEMAT) assessment: Two co-investigators will assess each revised text, masked to intervention group. Relevant PEMAT #5 is: The text uses active voice Relevant reference : S.J. Shoemaker, M.S. Wolf, C. Brach, Development of the Patient Education Materials Assessment Tool (PEMAT): a new measure of understandability and actionability for print and audiovisual patient information, Patient Educ Couns 96(3) (2014) 395-403. PMID:24973195.
Timepoint [13] 420624 0
Participants are asked to complete the revision task within the week after completing the training.
Secondary outcome [14] 433590 0
Health literacy expert rating of the extent that the revised text retains the key content in the original text. Ratings are recorded on a 5-point likert scale (Strongly disagree to strongly agree).
Timepoint [14] 433590 0
Participants are asked to complete the revision task within the week after completing the training.

Eligibility
Key inclusion criteria
Eligible participants are Australian people whose work or study involves developing health information. This can include, for example, health information providers, health services staff, and clinicians. Students in medicine, allied health and health sciences are also eligible to take part. Participants are not eligible to take part if they have previous experience using the Health Literacy Editor.

For consumers rating the resulting revised health information, eligible participants must be adults (18 years and over) with less than a university level of education.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants are not eligible to take part if they have previous experience using the Health Literacy Editor.

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)
Allocation takes place via the online survey platform Qualtrics and is therefore concealed from all investigators.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised to intervention group using the ‘Randomiser’ function included in the survey platform (Qualtrics). The ‘Randomiser’ is based on the Mersenne Twister, a pseudorandom number generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Univariable regression models will be performed to analyse differences in outcome measures for resources developed using the Health Literacy Editor (intervention) and control.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/05/2023
Actual
31/05/2023
Date of last participant enrolment
Anticipated
Actual
26/11/2023
Date of last data collection
Anticipated
Actual
12/02/2024
Sample size
Target
180
Accrual to date
Final
188
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313117 0
Government body
Name [1] 313117 0
National Health and Medical Research Council
Country [1] 313117 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Edward Ford Building (A27), The University of Sydney, NSW, 2006
Country
Australia
Secondary sponsor category [1] 315329 0
None
Name [1] 315329 0
Address [1] 315329 0
Country [1] 315329 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312366 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 312366 0
Ethics committee country [1] 312366 0
Australia
Date submitted for ethics approval [1] 312366 0
17/03/2023
Approval date [1] 312366 0
18/05/2023
Ethics approval number [1] 312366 0

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

Contacts
Principal investigator
Name 124402 0
Dr Julie Ayre
Address 124402 0
Edward Ford Building (A27) The University of Sydney NSW 2006
Country 124402 0
Australia
Phone 124402 0
+61 293517789
Fax 124402 0
Email 124402 0
[email protected]
Contact person for public queries
Name 124403 0
Julie Ayre
Address 124403 0
Edward Ford Building (A27) The University of Sydney NSW 2006
Country 124403 0
Australia
Phone 124403 0
+61 293517789
Fax 124403 0
Email 124403 0
[email protected]
Contact person for scientific queries
Name 124404 0
Julie Ayre
Address 124404 0
Edward Ford Building (A27) The University of Sydney NSW 2006
Country 124404 0
Australia
Phone 124404 0
+61 293517789
Fax 124404 0
Email 124404 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• publicly available

Conditions for requesting access:
• -

What individual participant data might be shared?
• Grade reading score and secondary outcomes using deidentified data

What types of analyses could be done with individual participant data?
• meta-analysis

When can requests for individual participant data be made (start and end dates)?
From:
public repository, available once trial results are published. No end date.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• data will be made publicly available (repository to be confirmed)

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?




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.