TRECA (Phase 1 - user testing study)
Research type
Research Study
Full title
The TRECA study: TRials Engagement in Children and Adolescents
IRAS ID
213557
Contact name
Peter Knapp
Contact email
Sponsor organisation
University of York
Duration of Study in the UK
2 years, 2 months, 30 days
Research summary
Randomised controlled trials enable us to determine the effectiveness of healthcare interventions. However, few trials involve children and adolescents meaning that decisions about their care are based on evidence from trials involving adults. A key barrier to recruiting children and adolescents is the quality of current participant information sheets which are often too long and difficult to read. The TRECA study will develop two multimedia information (MMI) resources which will look like websites and aim to be more engaging than current participant information sheets by including a mixture of text, audio, video and animation. MMI 1 will be for younger children (aged 6-11 years) and their parents, MMI 2 will be for adolescents (aged 12-17 years) and their parents. The MMIs aim to better inform potential trial participants, thus leading to increased recruitment and retention to trials.
The TRECA study has two phases; phase 1 involves the development of the MMIs, phase 2 involves testing the MMIs in 6 host clinical trials. This application relates to phase 1, study 2 (phase 1, study 1 has previously been approved – IRAS ID 195396). Study 2 will user test the MMIs to determine whether the information in the MMIs can be easily found and understood. User testing involves participants being asked to find and demonstrate understanding of information within the MMI. For example participants asked “how many times would you visit the hospital during the trial?” would first need to locate the information within the MMI, and then demonstrate understanding of the information by explaining the answer e.g. there would be 5 hospital visits.
The MMIs will be user tested by children, adolescents and parents in rounds of 20 participants. After each round, the MMIs are edited based on any difficulties participants had with using the MMIs, or understanding the information within them.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
16/YH/0387
Date of REC Opinion
2 Sep 2016
REC opinion
Favourable Opinion