Authors' objectives: The aim of the TRECA study is to improve the engagement of children and young people with long-term conditions in clinical trials. Patients are usually informed about a trial via printed information sheets, which have been much criticised for being too long and technical to inform patients adequately. Multimedia interventions - that is a computer-based information resource including some text, some audio, some video and animations - offer the potential for better informing patients (and their parents). Some existing research with adult patients suggests that they may work well to inform people about medical procedures and research participation. There is no current research in younger patients. In this study patients would be provided with an information resource viewed on a computer which will include details both of the trial that the patient is being asked to consider, and trials in general. The resource includes content that the user reads, as well as some short video clips (featuring talking heads ) that the user can watch and listen to. The user can choose which sections to read and view, and in which order. It may be possible for the user to post questions on the MMI, so making it interactive. We will develop 2 MMIs, one for parents and young people being asked for consent, and another (less complex) for younger children at an earlier development stage (being informed about a trial or being asked for assent). The two MMIs will mostly feature content that would apply to all trials and a lesser amount that will apply to the specific trial that the patient is being asked to consider. We have experience of developing a similar MMI for use in trials with adults, and will draw on that experience for this work involving children and young people. The study will have 2 phases. First we will develop and test the MMIs. Second we will evaluate the effects of the MMIs in 6 different healthcare trials involving children and young people. In the development and testing phase we will conduct group discussions with children and young people, parents and clinical staff, to identify preferences for content, tone, style, delivery, etc. We will then develop the MMIs before returning to the groups for more discussion. Then revise the MMIs as required. The MMIs will then be tested for people s ability to find and understand content. We will do this by conducting individual interviews with children, young people and parents. After a round of 20 people on each MMI, we will revise them as necessary. Then test them again, then revise as needed. In the evaluation phase we will use the MMIs in 6 host healthcare trials, with potential host trial participants seeing either the standard written trial information or the standard written information plus the MMIs. They will see the MMI(s) when being asked to take part in the host trial. We will assess participants decisions that is, how sure they are that they have made the right decision and how satisfied they were with the process and also look at rates of recruitment to the healthcare trials and how long people stay on them. We will combine the results of the 6 trials statistically. Children and young people (and parents) will be involved throughout as a study PPI group: piloting materials, helping to run discussion groups and jointly presenting study results. We will report the results in journals, at conferences and in presentations to specialist centres that run children's trials.

Project Status: Ongoing

URL for project: http://www.nets.nihr.ac.uk/projects/hsdr/142121

Anticipated Publish Date: 2021

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England, United Kingdom

Organisation Name: NIHR Health Services and Delivery Research programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk

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