Developing and evaluating multimedia information resources to improve engagement of children, adolescents and their parents with trials

Not Applicable

Completed

• Conditions: ong-term health conditions; Not Applicable

• Registration Number: ISRCTN73136092
• Lead Sponsor: niversity of York

Brief Summary

2017 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/28595613 protocol 2019 Interim results article in https://www.ncbi.nlm.nih.gov/pubmed/30782720 Qualitative results (added 12/02/2020) 2019 Other publications in https://doi.org/10.1186/s13063-019-3236-4 Challenges encountered in embedding MMIs (added 16/03/2021) 2020 Other publications in https://www.scienceopen.com/document?vid=5f61efb7-11e2-4556-831b-587a0e89b359 PPI work (added 16/03/2021) 2019 Other publications in https://pubmed.ncbi.nlm.nih.gov/30384772/ User testing (added 16/03/2021) 2018 Other publications in https://doi.org/10.1177/1367493518807325 User testing (added 16/03/2021) 2021 Interim results article in https://pubmed.ncbi.nlm.nih.gov/34227411/ Results from BAMP host trial (added 14/11/2022) 2022 Interim results article in https://pubmed.ncbi.nlm.nih.gov/35831055/ Results from FORCE host trial (added 14/11/2022) 2022 Interim results article in https://doi.org/10.12688/f1000research.110083.1 Results from Thermic-3 host trial (added 14/11/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/38140894/ (added 27/12/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-24
• Study Completion: 2021-11-30
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1906

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.<br>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).