An embedded randomised controlled trial of a comic-enhanced vs standard participant information sheet, on child and parent understanding of key trial information

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12620001162909

Acronym

CAREtoon sub-study (Children's Anti-inflammatory REliever sub-study)

Enrollment

104

Registered

2020-11-05

Start date

2021-01-28

Completion date

2022-05-14

Last updated

2023-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Educational / counselling / training

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

5 Years to No maximum

Healthy volunteers

Yes

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.

Exclusion criteria

None

Outcome results