TRECA Phase 2: multimedia information for assisting trial recruitment
Research type
Research Study
Full title
The TRECA study: TRials Engagement in Children and Adolescents - Phase 2
IRAS ID
212761
Contact name
Peter Knapp
Contact email
ISRCTN Number
ISRCTN73136092
Duration of Study in the UK
1 years, 2 months, 29 days
Research summary
Randomised controlled trials (RCTs) are the gold standard of healthcare research, however few trials involve children and adolescents. A key barrier to the success of RCTs is the recruitment and retention of participants, which is especially problematic in paediatric trials where patient/parent refusal to participate is high. Thus, medical decisions are sometimes made based on evidence extrapolated from adults.
The TRECA study aims to develop new ways to help patients make decisions about taking part in clinical trials, and test whether these methods can increase patient recruitment and retention to ongoing clinical trials in the NHS.
In phase 1 of TRECA, two multimedia information (MMI) resources (one for children and their parents, one for adolescents and their parents) are being developed. These MMIs are like websites which contain text, video and animation, and aim to be more engaging and easy to read than traditional informational material. The style and content of the MMIs was informed through focus groups with children, adolescents, parents and researchers/clinicians (phase 1, study 1 - IRAS ID 195396). The MMIs will be tested by children, adolescents and parents to ensure they are easy to use and understand prior to phase 2 (phase 1, study 2 - IRAS ID 213557).
This application is limited to phase 2 of TRECA which involves testing the MMIs in ongoing trials. These are ‘host’ trials which the TRECA study is ‘embedded’ into. The ‘host’ trial will continue as normal but eligible trial participants will be given either the ‘host’ trial's standard information materials, the standard information materials plus an age-appropriate MMI, or the MMI alone. Thus, the ‘embedded’ TRECA study is a recruitment study within a trial. ‘Host’ trial data will demonstrate whether MMIs can increase recruitment and retention. The quality of prospective trial participant’s decision-making will also be assessed.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
17/YH/0082
Date of REC Opinion
29 Mar 2017
REC opinion
Favourable Opinion