Case Study

The SCIPI Trial


SCIPI is a randomised controlled trial to compare the effectiveness of continuous subcutaneous insulin infusion and multiple daily injection regimens in children and young people newly diagnosed with type I diabetes mellitus.

The SCIPI Trial: Summary

The study is designed to find out whether insulin treatment using insulin pumps is more effective than insulin treatment using insulin injections in babies, children and young people who have just been diagnosed with type I diabetes.

The trial was sponsored by Alder Hey Children’s NHS Foundation Trust, funded by National Institute for Health Research Health Technology Assessment Programme and coordinated by The University of Liverpool Clinical Trials Research Centre.

What we did

The SCIPI trial at Alder Hey Children’s Hospital was used during Phase 1 of the TRECA project to develop the multi media materials MMI’s.

The aim of using the SCIPI trial was to test the materials and the process of developing them in a live situation. The following is a summary of the intention set out for Phase 1 of the project:

Phase 1 – Development

  • The research team will develop two MMIs (one for adolescents and their parents; and another for younger children and their parents) for use when children and adolescents are asked to consider taking part in a healthcare trial. Both MMIs will contain generic trial information (e.g. on randomisation, study withdrawal) and information specific to an individual trial (e.g. its purpose, length, any additional hospital appointments for participants).  The content of the MMIs will reflect the content found in a traditional participant information sheet.
  • The MMI development will be influenced by the views of relevant stakeholders (i.e. children and adolescents with long-term conditions, parents, clinicians, etc). The MMIs will also be ‘user tested’ for their ability to inform patients/parents. This process will identify any parts of the MMI which are not understood by users and can be improved by the research team.

The websites also included the set of generic Clinical Trial animations featured below.

SCIPI Participant Information Animation

SCIPI Participant Information Animation

This is the Participant Information Animation that we made for the home page of the SCIPI Trial Patient Information Website.

SCIPI Talking Head Video

SCIPI Talking Head Video

This is an example of one of the Talking Heads videos that we produced for the SCIPI MMI’s. The filming was actually logistically really complicated and important lessons were learned about filming in a hospital environment. As well as the Principal Investigator we included talking heads from patients and parents.

Clinical Trial Animations

As part of the TRECA Study we produced a range of clinical trial animations to explain key concepts.

What is a trial?
Who is in a research team?
Why do we do trials?
Consent and assent