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Contact Information:

Dr Peter Knapp
+44 (0)1904 321675
peter.knapp@york.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - Developing and evaluating multimedia information resources to improve engagement of children, adolescents and their parents with trials
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Developing and evaluating multimedia information resources to improve engagement of children, adolescents and their parents with trials

Not Recruiting

Open to: All Genders

Age: Child

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Medical Conditions

Long-term health conditions

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Patients are usually informed about clinical trials using printed participant information sheets, which have been much criticised for being too long and technical to inform patients adequately. Multimedia information resources (MMIs) are computer-based and include text, audio, video and animations. 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. Studies with adult patients suggest that MMIs may work, but they have not been tested with younger patients. The aim of this study is to compare three methods of providing information to potential trial participants: participant information sheet alone, participant information sheet plus an MMI, or the MMI alone.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Mar 2017 31 Mar 2021

Publications

2017 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/28595613 protocol2019 Interim results article in https://www.ncbi.nlm.nih.gov/pubmed/30782720 Qualitative results (added 12/02/2020)2019 Other publications in https://doi.org/10.1186/s13063-019-3236-4 Challenges encountered in embedding MMIs (added 16/03/2021)2020 Other publications in https://www.scienceopen.com/document?vid=5f61efb7-11e2-4556-831b-587a0e89b359 PPI work (added 16/03/2021)2019 Other publications in https://pubmed.ncbi.nlm.nih.gov/30384772/ User testing (added 16/03/2021)2018 Other publications in https://doi.org/10.1177/1367493518807325 User testing (added 16/03/2021)2021 Interim results article in https://pubmed.ncbi.nlm.nih.gov/34227411/ Results from BAMP host trial (added 14/11/2022)2022 Interim results article in https://pubmed.ncbi.nlm.nih.gov/35831055/ Results from FORCE host trial (added 14/11/2022)2022 Interim results article in https://doi.org/10.12688/f1000research.110083.1 Results from Thermic-3 host trial (added 14/11/2022)2023 Results article in https://pubmed.ncbi.nlm.nih.gov/38140894/ (added 27/12/2023)

The study has two phases. In the first phase two MMIs are developed, one for parents and adolescents, and another (less complex) for younger children and their parents. The two MMIs mostly feature content that applies to all trials and some content that applies to the specific trial that the patient is being asked to consider. This content reflects the content found in a traditional participant information sheet. Group discussions are conducted with children and adolescents, parents and clinical staff, to identify preferences for content, tone, style and delivery. The MMIs are developed before returning to the groups for more discussion. The MMIs are then revised as required. The MMIs are then tested for people’s ability to find and understand the content by conducting individual interviews with children, adolescents and parents. After a round of 20 people on each MMI, they are revised and tested again as necessary. In the second phase the effects of the MMIs are evaluated in six different healthcare trials involving children and adolescents. When being asked to take part in the trials, potential trial participants are randomly allocated to see the standard written trial information, the standard written information plus an MMI, or the MMI alone. The study assesses participants’ decisions, how sure they are that they have made the right decision, how satisfied they were with the process, and also looks at rates of recruitment to the trials and how long people stay on them.


Children and adolescents aged 6-17 with long-term health conditions

You can take part if:



You may not be able to take part if:


1. Paediatric patients who cannot participate in informed consent due to being too young (less than 6 years) or due to intellectual disability2. Paediatric patients or their parents who do not speak English


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • University of York
    YO10 5DD

Possible benefits are that participants may be able to make a more informed decision about trial participation as they will receive additional information in a more accessible and engaging format. No risks identified by participating other than loss of time for those participants who receive the MMI and participant information sheet as a result of receiving additional information about the trial available.

Dr Peter Knapp
+44 (0)1904 321675
peter.knapp@york.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by University of York and funded by Health Services and Delivery Research Programme.



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Read full details for Trial ID: ISRCTN73136092

Or CPMS 34149

Last updated 27 December 2023

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.   

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