Developing and evaluating multimedia information resources to improve engagement of children, adolescents and their parents with trials
| ISRCTN | ISRCTN73136092 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73136092 |
| Secondary identifying numbers | HS&DR 14/21/21 |
- Submission date
- 23/08/2016
- Registration date
- 24/08/2016
- Last edited
- 27/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
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 information resources (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 three methods of providing information to potential trial participants: participant information sheet alone, participant information sheet plus an MMI, or the MMI alone.
Who can participate?
Children and adolescents 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 adolescents, and another (less complex) for younger children and their parents. 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. This content reflects the content found in a traditional participant information sheet. Group discussions are conducted with children and adolescents, 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, adolescents 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 adolescents. When being asked to take part in the trials, potential trial participants are randomly allocated to see the standard written trial information, the standard written information plus an MMI, or the MMI alone. 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 for those participants who receive the MMI and participant information sheet 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 November 2021 (updated 20/04/2021, previously: April 2021 (updated 08/07/2020, previously: December 2018))
Who is funding the study?
Health Services and Delivery Research Programme (UK)
Who is the main contact?
Dr Jackie Martin-Kerry
jackie.martin-kerry@york.ac.uk
Contact information
Public
Department of Health Sciences & the Hull York Medical School
ATB 224 (Area 4)
University of York
York
YO10 5DD
United Kingdom
| Phone | +44 (0)1904 321675 |
|---|---|
| peter.knapp@york.ac.uk |
Study information
| Study design | Multi-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Trials Engagement in Children and Adolescents (TRECA): a randomised controlled trial |
| Study 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. Updated 04/05/2017: This study will compare three methods of providing information to potential trial participants: the participant information sheet alone, the participant information sheet plus an MMI or the MMI alone, to determine effects on recruitment, retention rates and quality of decision making. |
| Ethics approval(s) | 1. Phase 1 qualitative study: Yorkshire and The Humber Research Ethics Committee, 13/04/2016, ref: 16/YH/0158; IRAS ID 195396 2. Phase 1 user testing study: Yorkshire & The Humber – Bradford Leeds Research Ethics Committee, 02/09/2016, ref: 16/YH/0387; IRAS ID 213557 3. Phase 2: Yorkshire & The Humber – Bradford Leeds Research Ethics Committee, 29/03/2017, ref: 17/YH/0082; IRAS ID 212761 |
| Condition | Long-term health conditions |
| Intervention | Current interventions as of 04/05/2017: 1. Intervention group 1 (receives information about the trial by MMI plus standard participant information sheet) 2. Intervention group 2 (receives information about the trial by MMI alone) 3. Control group (standard participant information sheet only): receives trial information only through standard participant information sheet Previous interventions: 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 |
| Primary outcome measure | 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 study start date | 01/03/2016 |
| Overall study end date | 30/11/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 17 Years |
| Sex | Both |
| Target number of participants | 783 |
| Total final enrolment | 1906 |
| 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 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 | 31/03/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
United Kingdom
Sponsor information
University/education
Heslington
York
YO10 5DD
England
United Kingdom
| Phone | +44 (0)1904 435154 |
|---|---|
| michael.barber@york.ac.uk | |
"ROR" |
https://ror.org/04m01e293 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Health Services and Delivery Research (HS&DR) Programme, NIHR Health Services and Delivery Research (HS&DR) Programme, NIHR Health Services and Delivery Research Programme, HS&DR Programme, HS&DR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | A protocol paper will be published in 2017. The results of the study will be published in a range of peer-reviewed journals including open access journals. Key findings will also be presented at conferences. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from the TRECA research team. All data requests will be managed according to the Department of Health Sciences, University of York processes and procedures. The TRECA research team may be contacted at: treca@york.ac.uk. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 08/06/2017 | Yes | No | |
| Interim results article | Qualitative results | 09/01/2019 | 12/02/2020 | Yes | No |
| Other publications | Challenges encountered in embedding MMIs | 01/12/2019 | 16/03/2021 | Yes | No |
| Other publications | PPI work | 01/02/2020 | 16/03/2021 | Yes | No |
| Other publications | User testing | 01/09/2019 | 16/03/2021 | Yes | No |
| Other publications | User testing | 01/11/2018 | 16/03/2021 | Yes | No |
| Interim results article | Results from BAMP host trial | 06/07/2021 | 14/11/2022 | Yes | No |
| Interim results article | Results from FORCE host trial | 13/07/2022 | 14/11/2022 | Yes | No |
| Interim results article | Results from Thermic-3 host trial | 21/03/2022 | 14/11/2022 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| HRA research summary | 28/06/2023 | No | No | ||
| HRA research summary | 26/07/2023 | No | No | ||
| Results article | 01/11/2023 | 27/12/2023 | Yes | No |
Editorial Notes
27/12/2023: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
14/11/2022: Publication references added.
20/04/2021: The following changes were made to the trial record:
1. The overall end date was changed from 30/04/2021 to 30/11/2021.
2. The intention to publish date was changed from 30/09/2021 to 31/12/2021.
3. The plain English summary was updated to reflect these changes.
16/03/2021: The following changes were made to the trial record:
1. The intention to publish date was changed from 30/06/2021 to 30/09/2021.
2. Publication references added.
08/07/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/06/2020 to 31/03/2021.
2. The overall end date was changed from 31/07/2020 to 30/04/2021.
3. The plain English summary was updated to reflect these changes.
05/05/2020: The public contact has been changed.
12/02/2020: Publication reference added.
18/01/2019: The recruitment end date has been changed from 31/12/2018 to 30/06/2020
17/01/2019: The following changes have been made to the trial record:
1. The overall trial end date has been changed from 31/12/2018 to 31/07/2020.
2. The intention to publish date has been changed from 01/12/2018 to 30/06/2021.
12/06/2017: Publication reference added.
04/05/2017: The following changes were made to the trial record:
1. The target number of participants was changed from 432 to 783.
2. The funder was changed from University of York to Health Services and Delivery Research Programme.
