PINPOINT-Fatigue is a research study looking at tiredness (fatigue) in children and young people. The study focuses on children and young people with inflammatory bowel disease (IBD) and also includes healthy children and young people. The aim is to better understand fatigue and how it affects everyday life and how best to manage it.

Many children and young people with IBD feel very tired, even when their condition is well controlled. We do not yet fully understand why this happens or how best to help. This study aims to:

• Understand how common fatigue is in children and young people with IBD

• Learn how fatigue affects school, mood, concentration, and daily activities

• Find out what helps children and families manage fatigue better

• Compare fatigue in children with IBD to children without a long-term illness

• The findings will help improve care and support for children and young people with IBD in the future.

Your child has been invited because they fall into one of the study groups:

• Children and young people diagnosed with IBD, or

• Children and young people with no long-term illness (healthy volunteers)

• Including both groups help researchers understand whether fatigue is more common or different in children with IBD.

No. Taking part is completely optional. You and your child can decide together. Choosing not to take part, or deciding to stop later, will not affect your child’s medical care in any way.

Yes. You and your child can leave the study at any time, without giving a reason. If you withdraw, no new information will be collected. Information already provided may still be used, but only in an anonymised way.

The study lasts 12 months and all activities can be done from home.

Your child will be asked to complete questionnaires, and you may also be invited to take part in optional interviews or group discussions.

The questionnaires ask about:

• Fatigue and energy levels

• Physical and mental wellbeing

• Daily activities, school, and social life

• If your child has IBD, there will also be some IBD-specific questions.

The questionnaires take about 40 minutes to complete. Your child can take breaks and complete them:

• Online using a secure link sent by email, or

• On paper, sent and returned by post

• Your child will be asked to complete questionnaires twice over the 12 months.

You and your child may be invited to take part in optional activities, such as:

• A one-to-one interview where your child talks about how fatigue affects daily life

• An interview giving feedback on a new fatigue questionnaire being developed for children and young people with IBD

• A small group discussion (focus group) with other young people or parents/guardians

• Online webinars and question-and-answer sessions with IBD experts

You can choose to take part in all, some, or none of these. Saying no will not affect participating in the rest of the study.

No. All activities can be done remotely. Some group discussions may be offered in person close to where you live, but this is entirely optional.

Yes, but only with your permission. Interviews and group discussions are audio-recorded so researchers can accurately remember and understand what participants say. Recordings are:

• Stored securely

• Transcribed into written notes

• Deleted once checked for accuracy

• All names and identifying details are removed.

How will my child’s information be kept confidential?

·         Your child is given a study ID number

·         Names and contact details are kept only by the research study team in order to contact you. These are kept separate from research data

• Only the research team can link information back to your child

• Data are stored securely on password-protected systems

• Paper documents are kept in locked filing cabinets

• All data are handled according to UK data protection laws.

Some anonymised information may be shared with trusted research partners to help answer specific research questions. No names or direct identifying details are shared, and strict data protection agreements are always in place.

No. Your child will continue to receive their usual NHS care, whether or not they take part in the study.

There may not be a direct benefit for your child, but families often value:

• Helping researchers better understand fatigue in children and young people with IBD

• Contributing to the development of a new fatigue questionnaire

• Sharing experiences with researchers and others living with IBD

• Learning more through webinars and Q&A sessions

• As a thank you, participants who complete the study will receive a small gift voucher.

The main disadvantage is the time involved in completing questionnaires or interviews. The research team will be flexible and work around your family’s schedule.

The results will be published in medical journals and shared with patient groups. Everything will be anonymous. Easy-to-read summaries will be shared with all participants, families and IBD charities.

The study is organised by the Department of Child Life and Health at the University of Edinburgh and NHS Lothian. It is funded by Crohn’s and Colitis UK.

An independent NHS Research Ethics Committee has reviewed and approved the study to make sure it is safe, ethical, and respectful of participants.

If you have questions or concerns, you can contact the PINPOINT-Fatigue research team:

Email: pinpoint@ed.ac.uk

Phone/Text: 07551 915 674