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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

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

Authors: Jacqueline Martin-Kerry, Peter Bower, Bridget Young, Jonathan Graffy, Rebecca Sheridan, Ian Watt, Paul Baines, Catherine Stones, Jennifer Preston, Steven Higgins, Carrol Gamble, Peter Knapp

Published in: Trials | Issue 1/2017

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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.

Trial registration

ISRCTN registry: ISRCTN73136092 (doi:10.​1186/​ISRCTN73136092). Registered on 24 August 2016.
Appendix
Available only for authorised users
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Metadata
Title
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
Authors
Jacqueline Martin-Kerry
Peter Bower
Bridget Young
Jonathan Graffy
Rebecca Sheridan
Ian Watt
Paul Baines
Catherine Stones
Jennifer Preston
Steven Higgins
Carrol Gamble
Peter Knapp
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-1962-z

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