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Trial registered on ANZCTR


Registration number
ACTRN12620001162909
Ethics application status
Approved
Date submitted
3/09/2020
Date registered
5/11/2020
Date last updated
5/04/2023
Date data sharing statement initially provided
5/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
An embedded randomised controlled trial of a comic-enhanced vs standard participant information sheet, on child and parent understanding of key trial information
Scientific title
An open-label, embedded randomised controlled trial of a comic-enhanced vs standard participant information sheet, on the comprehension of key trial information, for children with asthma and their parents in the CARE study
Secondary ID [1] 302217 0
MRINZ/20/06A
Universal Trial Number (UTN)
U1111-1246-8198
Trial acronym
CAREtoon sub-study (Children's Anti-inflammatory REliever sub-study)
Linked study record
ACTRN12620001091998 (Parent study)

Health condition
Health condition(s) or problem(s) studied:
Asthma 318914 0
Condition category
Condition code
Respiratory 316894 316894 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A comic-enhanced version of the standard Participant Information Sheet for the parent CARE study (CAREtoon PIS), is the intervention in the sub-study. This is a modified version of the standard Participant Information Sheet (PIS) documents for the CARE study, which begin with a 2-page comic overview of the CARE study. The content has been designed by a Medical Illustrator experienced in creating comics, in collaboration with a multidisciplinary committee within the study team including a paediatrician, asthma and clinical research experts, and non-medical staff. Additional feedback from a Maori doctor regarding the suitability for a Maori audience, lay parents and their children (including children with asthma) have informed the design.

Parents/guardians who request for information about the CARE study at selected sites, will be randomised to receive one of two versions of the CARE study PIS (the CAREtoon PIS, or the standard PIS). This will be provided in electronic PDF or paper form, at the enquirer's preference approximately 48 hours to 2 weeks before a CARE study screening visit, at which enrolment to the sub-study and parent study will take place for eligible and interested volunteers.
Intervention code [1] 318509 0
Behaviour
Comparator / control treatment
A standard Participant Information Sheet for the parent CARE study (standard PIS), is the control in the sub-study.

The standard PIS follows the New Zealand Health and Disability Ethics Committee templates. It has been designed in collaboration with a multidisciplinary committee within the study team including a paediatrician, asthma and clinical research experts, and non-medical staff. Additional feedback from a Maori doctor regarding the suitability for a Maori audience, lay parents and their children (including children with asthma) has been informed the design.
Control group
Active

Outcomes
Primary outcome [1] 324996 0
Child comprehension of key study elements after receiving either the standard or CAREtoon PIS as determined by mDICCT (modified Deaconness Informed Consent Comprehension Test) score, adjusted for health literacy by REALM-TeenS score
Timepoint [1] 324996 0
Between 48 hrs and 2 weeks after the PIS is sent, at the parent CARE study screening visit (week 0 of the CARE study)
Secondary outcome [1] 386495 0
Parent/guardian comprehension of key study elements after receiving either the standard or CAREtoon PIS as determined by mQuIC (modified Quality of Informed Consent) score, adjusted for health literacy by REALM-SF score
Timepoint [1] 386495 0
Between 48 hrs and 2 weeks after the PIS is sent, at the parent CARE study screening visit (week 0 of the CARE study)
Secondary outcome [2] 386496 0
The proportion of CARE study enquiries which progressed to a CARE study screening visit after sending PIS. This will be determined by records from the study database.
Timepoint [2] 386496 0
Within 3 weeks of being sent a PIS, at the end of the CARE study screening visit (if booked and attended) or when this would have occurred (if not booked). This would be week 0 of the Parent CARE study if they enrol at the screening visit.
Secondary outcome [3] 386498 0
Proportion of CARE study enquiries which progressed to CARE study enrolment after sending a PIS. This will be determined by records from the study database.
Timepoint [3] 386498 0
Within 3 weeks of being sent a PIS, at the end of the CARE study screening visit (if booked and attended) or when this would have occurred (if not booked). This would be week 0 of the Parent CARE study if they enrol at the screening visit.
Secondary outcome [4] 386499 0
Percentage of PIS read by those who do not book a CARE study screening visit, as determined by a participant-rated visual analogue score
Timepoint [4] 386499 0
2 weeks after being sent a PIS
Secondary outcome [5] 386500 0
Qualitative analysis of an exit survey designed for this study to determine reasons for not booking a screening visit. This will be assessed by descriptive statistics and manual review of free-text responses.
Timepoint [5] 386500 0
2 weeks after being sent a PIS
Secondary outcome [6] 386501 0
Parent CARE study screening visit duration calculated from participant study records of the CARE study screening visit start and finish times.
Timepoint [6] 386501 0
Between 48 hrs and 2 weeks after the PIS is sent, at the parent CARE study screening visit (week 0 of the CARE study)
Secondary outcome [7] 386502 0
Percentage of PIS read by child determined by a participant-rated visual analogue score
Timepoint [7] 386502 0
Between 48 hrs and 2 weeks after the PIS is sent, at the parent CARE study screening visit (week 0 of the CARE study)
Secondary outcome [8] 386503 0
Proportion of children who the PIS helped to understand the parent CARE study as determined by a participant feedback survey designed for this study
Timepoint [8] 386503 0
Between 48 hrs and 2 weeks after the PIS is sent, at the parent CARE study screening visit (week 0 of the CARE study)
Secondary outcome [9] 386504 0
Parent-rated amount PIS helped to understand the CARE study on a visual analogue scale
Timepoint [9] 386504 0
Between 48 hrs and 2 weeks after the PIS is sent, at the parent CARE study screening visit (week 0 of the CARE study)
Secondary outcome [10] 386505 0
Parent-rated amount PIS helped to explain CARE study to their child, on a visual analogue scale
Timepoint [10] 386505 0
Between 48 hrs and 2 weeks after the PIS is sent, at the parent CARE study screening visit (week 0 of the CARE study)
Secondary outcome [11] 386506 0
Parent-rated amount comic illustrations helped when explaining parent CARE study to their child, on a visual analogue scale
Timepoint [11] 386506 0
Between 48 hrs and 2 weeks after the PIS is sent, at the parent CARE study screening visit (week 0 of the CARE study)
Secondary outcome [12] 386507 0
Device/media used to read the PIS sent as determined by study-specific survey response
Timepoint [12] 386507 0
Between 48 hrs and 2 weeks after the PIS is sent, at the parent CARE study screening visit (week 0 of the CARE study)
Secondary outcome [13] 387510 0
Percentage of PIS read by parent determined by a participant-rated visual analogue score
Timepoint [13] 387510 0
Between 48 hrs and 2 weeks after the PIS is sent, at the parent CARE study screening visit (week 0 of the CARE study)
Secondary outcome [14] 409280 0
Proportion of parent/guardians who would have preferred to receive each version of the PIS as determined by selection of preferred resource from the two available PIS choices.
Timepoint [14] 409280 0
Between 48 hrs and 2 weeks after the PIS is sent (although no upper limit) at the parent CARE study screening visit (week 0 of the CARE study participation)
Secondary outcome [15] 409281 0
Proportion of children who would have preferred to receive each version of the PIS as determined by selection of preferred resource from the two available PIS choices.
Timepoint [15] 409281 0
Between 48 hrs and 2 weeks after the PIS is sent (although no upper limit) at the parent CARE study screening visit (week 0 of the CARE study participation)

Eligibility
Key inclusion criteria
Any parent/guardian and child dyad who are potentially eligible for the parent CARE study, who have received a PIS for the main CARE study, and who attend a screening visit at the sub-study sites. CARE study inclusion criteria: child must aged 5 to 15 years, with a doctors diagnosis of asthma (parent/participant-reported), who have used a SABA reliever as sole asthma medication in the previous three months. Parents can be any age and in any condition of health.
Minimum age
5 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)
Allocation concealment will be by a secure database, which contains the randomisation sequence. A participant's PIS allocation will only be revealed to the researchers when that participant is randomised via the electronic case report form (eCRF).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed using a computer-generated sequence with varying block size between four and eight per site, and anticipated minimum centre size of 24, to maintain allocation concealment. This will be generated by the study statistician, independent of the Investigators.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Sample size is limited to the number of participants recruited from the selected participating sites, for which we aim to recruit at least 100 parent/guardian-child dyads. An achieved sample size of 50 per group has 80% power to detect a standardized mean difference of 0.56, or 90% power to detect a standardized mean difference of 0.65 (regarded as a medium-large effect by Cohen’s standards of effect sizes).

Child comprehension scores (mDICCT) will be analysed by ANCOVA with REALM-TeenS score and number of days with PIS resource prior to study visit as covariates, and randomised group as the main explanatory variable of interest.

Parent comprehension scores (mQuIC) will be analysed by ANCOVA with REALM-SF score and number of days with PIS resource prior to study visit as covariates, and randomised group as the main explanatory variable of interest.

Estimation of relative risk and associated confidence interval:
- Proportion of CARE study enquiries which progressed to CARE study screening visit after sending PIS
- Proportion of CARE study enquiries which progressed to CARE study enrolment after sending PIS
- Proportion of children who the PIS helped understand the study
- Proportion of parent/guardians and children who would have preferred to receive each version of the PIS

T-test or if normality assumptions are strongly violated, Mann-Whitney test with Hodges-Lehmann estimator of location:
- Percentage PIS read (VAS) by those who do not progress enquiry to screening visit
- Percentage of PIS read (VAS) by adults and children
- Percentage (VAS) how much did PIS help with understanding
- Percentage (VAS) how much did PIS help with explaining to child
- Percentage (VAS) how much did comic illustrations help with explaining to child

Descriptive statistics will be generated as follows: categorical data will be described by counts and proportions; count data will be described by rates and total counts in relation to observation time; ordinal data will be described by cross-tabulation and summaries as described for continuous data; and continuous data will be described by mean and standard deviation (SD), median and 25th and 75th percentiles as the inter-quartile range (IQR), and minimum (min) to maximum (max) as the range. Free-text data will be manually reviewed by the study team without formal qualitative analysis. This applies to:
- Exit survey for those who do not progress a CARE study enquiry to a screening visit
- Feedback survey for parent/guardian and child participants of the CAREtoon sub-study

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/11/2020
Actual
28/01/2021
Date of last participant enrolment
Anticipated
30/06/2022
Actual
14/05/2022
Date of last data collection
Anticipated
30/06/2022
Actual
14/05/2022
Sample size
Target
100
Accrual to date
Final
104
Recruitment outside Australia
Country [1] 22915 0
New Zealand
State/province [1] 22915 0

Funding & Sponsors
Funding source category [1] 306638 0
Government body
Name [1] 306638 0
Health Research Council of New Zealand
Country [1] 306638 0
New Zealand
Funding source category [2] 306643 0
Charities/Societies/Foundations
Name [2] 306643 0
Cure Kids
Country [2] 306643 0
New Zealand
Primary sponsor type
Other
Name
Medical Research Institute of New Zealand
Address
Level 7 CSB Building
Wellington Hospital
Riddiford St
Newtown
Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 307189 0
None
Name [1] 307189 0
Address [1] 307189 0
Country [1] 307189 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306823 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 306823 0
Ministry of Health
Ethics Department
Freyberg Building
Reception - Ground Floor
20 Aitken Street
Wellington 6011
Ethics committee country [1] 306823 0
New Zealand
Date submitted for ethics approval [1] 306823 0
20/08/2020
Approval date [1] 306823 0
17/09/2020
Ethics approval number [1] 306823 0
20/NTB/200

Summary
Brief summary
Informed consent/assent is important in healthcare and supported in the research setting by patient information resources. Research shows that the quality of informed consent is lacking, documents unwieldly, and that informed consent materials can be improved with pictures and comics, simpler text, and shorter-formats. We wish to conduct a randomized controlled trial as a sub-study of the parent CARE study, which compares how well two patient information resources prepare potential children and their parent/guardians for a screening visit and consent/assent, in terms of their comprehension of key trial information.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105134 0
Prof Richard Beasley
Address 105134 0
Medical Research Institute of New Zealand
Level 7 CSB Building
Wellington Hospital
Riddiford St
Newtown
Wellington 6021
Country 105134 0
New Zealand
Phone 105134 0
+6448050147
Fax 105134 0
Email 105134 0
[email protected]
Contact person for public queries
Name 105135 0
Ciléin Kearns
Address 105135 0
Medical Research Institute of New Zealand
Level 7 CSB Building
Wellington Hospital
Riddiford St
Newtown
Wellington 6021
Country 105135 0
New Zealand
Phone 105135 0
+64 48050201
Fax 105135 0
Email 105135 0
[email protected]
Contact person for scientific queries
Name 105136 0
Ciléin Kearns
Address 105136 0
Medical Research Institute of New Zealand
Level 7 CSB Building
Wellington Hospital
Riddiford St
Newtown
Wellington 6021
Country 105136 0
New Zealand
Phone 105136 0
+64 48050201
Fax 105136 0
Email 105136 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.