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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.


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Authors

Martin-Kerry, Jacqueline 
Bower, Peter 
Young, Bridget 
Graffy, Jonathan 
Sheridan, Rebecca 

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.

Description

Keywords

Adolescent, Child, Consent, Decision-making, Information, Intervention, Multimedia, Parent, Recruitment, Retention, Trial participation, Adolescent, Adolescent Behavior, Child, Child Behavior, Female, Focus Groups, Health Behavior, Health Knowledge, Attitudes, Practice, Humans, Informed Consent, Interviews as Topic, Male, Multimedia, Parents, Patient Dropouts, Patient Education as Topic, Patient Participation, Patient Selection, Qualitative Research, Research Subjects, Time Factors, United Kingdom

Journal Title

Trials

Conference Name

Journal ISSN

1745-6215
1745-6215

Volume Title

Publisher

Springer Science and Business Media LLC