Condition category
Not Applicable
Date applied
23/08/2016
Date assigned
24/08/2016
Last edited
24/08/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
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 interventions (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 two methods of providing information to potential trial participants: participant information sheet alone or participant information sheet plus MMI resource.

Who can participate?
Children and young people aged 6-17 with long-term health conditions

What does the study involve?
The study has two phases. In the first phase two MMIs are developed, one for parents and young people, and another (less complex) for younger children. 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. Group discussions are conducted with children and young people, 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, young people 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 young people. When being asked to take part in the trials, potential trial participants are randomly allocated to see the standard written trial information or the standard written information plus the MMIs. 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.

What are the possible benefits and risks of participating?
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 as a result of receiving additional information about the trial available.

Where is the study run from?
University of York (UK)

When is the study starting and how long is it expected to run for?
March 2016 to December 2018

Who is funding the study?
University of York (UK)

Who is the main contact?
Dr Jackie Martin-Kerry
jackie.martin-kerry@york.ac.uk

Trial website

http://www.york.ac.uk/healthsciences/research/health-policy/research/decision-making-projects/trials-engagement-in-children/#tab-1

Contact information

Type

Public

Primary contact

Dr Jackie Martin-Kerry

ORCID ID

http://orcid.org/0000-0002-9299-1360

Contact details

Area 2
Room A/TB/130
Seebohm Rowntree Building
Heslington
YO10 5DD
United Kingdom
+44 (0)1904 321826
jackie.martin-kerry@york.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HS&DR 14/21/21

Study information

Scientific title

TRials Engagement in Children and Adolescents (TRECA): a randomised controlled trial

Acronym

TRECA

Study hypothesis

The study is designed to develop and evaluate multimedia information resources (MMI) to improve the quality of decision making about recruitment to clinical trials involving children and adolescents with long-term health conditions. Participant information sheets are often criticised for being long and difficult to read and TRECA is investigating whether participant information provided in a multimedia format will increase recruitment of children and adolescents into healthcare trials and to also look at the effect on decision making and retention in trials.

This study will compare two methods of providing information to potential trial participants: either participant information sheet alone or participant information sheet plus MMI resource, to determine effects on recruitment, retention rates and quality of decision making.

Ethics approval

1. Phase 1 qualitative study: Yorkshire and The Humber Research Ethics Committee, 13/04/2016, ref: 16/YH/0158; IRAS ID 195396
2. Ethics approval for further components of TRECA will be obtained later in 2016 - pending

Study design

Multi-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Long-term health conditions

Intervention

1. Intervention group (receives information about the trial by MMI plus standard participant information sheet)
2. Control group (standard participant information sheet only): receives trial information only through standard participant information sheet

Intervention type

Other

Phase

Drug names

Primary outcome measures

Trial recruitment rates: the proportion of patients who agree to participate in the host trial, from the total number of patients approached, for each arm of the embedded trial at baseline.

Secondary outcome measures

1. Rates of retention of children and adolescents in the six host trials, measured by obtaining data on the number and timing of drop outs from each host trial at end/completion date of each of the six trials.
2. Quality of decision-making by respondents. The quality of decision-making by participants is a subjective outcome measure and will be measured at baseline through the completion of a quality of decision making scale by children, adolescents and parents (as relevant).

Overall trial start date

01/03/2016

Overall trial end date

31/12/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Paediatric patients who are aged between 6-17 years who have a long-term health condition and are eligible to be recruited into a host clinical trial
2. Both female and male

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

432

Participant exclusion criteria

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

Recruitment start date

01/03/2017

Recruitment end date

31/12/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of York
YO10 5DD
United Kingdom

Sponsor information

Organisation

University of York

Sponsor details

Heslington
York
YO10 5DD
United Kingdom
+44 (0)1904 435154
michael.barber@york.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University of York

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Results and Publications

Publication and dissemination plan

A protocol paper will be published in 2016. The results of the study will be published in a range of peer-reviewed journals including open access ones. Key findings will also be presented at conferences.

Intention to publish date

01/12/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes