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Developing and evaluating multimedia information resources to improve engagement of children, adolescents and their parents with trials (TRECA study) : study protocol for a series of linked randomised controlled trials.

Martin-Kerry, J. and Bower, P. and Young, B. and Graffy, J. and Sheridan, R. and Watt, I. and Baines, P. and Stones, C. and Preston, J. and Higgins, S. and Gamble, C. and Knapp, P. (2017) 'Developing and evaluating multimedia information resources to improve engagement of children, adolescents and their parents with trials (TRECA study) : study protocol for a series of linked randomised controlled trials.', Trials., 18 . p. 265.

Abstract

Background: Randomised controlled trials are widely established as the best method for testing health interventions whilst minimising bias. However, recruitment and subsequent retention of children and adolescents in healthcare trials is challenging. Participant information sheets are often lengthy and difficult to read and understand. Presenting key information using multimedia may help to overcome these limitations and better support young people and their parents in deciding whether to participate in a clinical trial. Methods: The TRECA (TRials Engagement in Children and Adolescents) study has two phases. The first phase involves a qualitative study with children and adolescents and their parents to inform the development of multimedia information resources and iterative user testing to refine the resources. The second phase will embed the use of the multimedia information resources into six host trials in the United Kingdom. Patients and parents approached to participate in the host trials will be randomly allocated to either use the multimedia information resource in conjunction with standard participant information sheets, the multimedia information resource alone, or the standard participant information sheets alone. The primary outcome will be the effect of the multimedia information resources on recruitment into trials. Other outcomes measured include the effect of multimedia information resources on retention of participants into the host trials and the impact on family members’ decision-making processes, when compared to standard participant information sheets alone. Discussion: This study will inform whether multimedia information resources, when developed using participatory design principles, are able to increase recruitment and retention of children and adolescents into trials. There is also the potential for patients to make better informed decisions through the use of multimedia information resources. The multimedia information resources also have the potential to assist with providing information on other healthcare decisions outside of clinical trials.

Item Type:Article
Full text:(AM) Accepted Manuscript
First Live Deposit - 01 June 2017
Available under License - Creative Commons Attribution.
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Full text:(VoR) Version of Record
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Status:Peer-reviewed
Publisher Web site:https://doi.org/10.1186/s13063-017-1962-z
Publisher statement:© The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Record Created:31 May 2017 14:58
Last Modified:13 Jun 2017 17:34

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