CompletedInterventional

A supported online self-management for symptoms of fatigue, pain and urgency/incontinence in people with inflammatory bowel disease: the IBD-BOOST trial

Many people living with inflammatory bowel disease (IBD) still experience gut pain, severe tiredness (fatigue), and bowel urgency, even when their gut inflammation is under control. The IBD-BOOST trial is testing whether an online self-management programme can help people manage these difficult, ongoing symptoms in their day-to-day lives. Participants are placed into one of two groups by chance. One group receives immediate access to an 11-session online programme, supported by a trained facilitator through phone calls and messaging over three months. The other group continues with their usual NHS care and is given access to the self-guided programme after 12 months. Both groups fill in questionnaires about their health at the start, at six months, and at 12 months. The study aims to provide practical coping tools to improve wellbeing without changing regular medical treatment.

At a glance

Status

Completed

Sponsor

London North West University Healthcare NHS Trust

Enrolment target

740

Start

18 Dec 2019

Estimated completion

31 Jul 2022

Inflammatory Bowel Disease (IBD)

What is this study about?

Inflammatory bowel disease (IBD), which includes Crohn's disease and ulcerative colitis, causes painful swelling in the digestive system. Even when medical treatments successfully calm down this inflammation, many people continue to live with exhausting fatigue, ongoing stomach pain, and sudden urges to use the toilet. These lasting symptoms can make it hard to work, travel, and enjoy everyday social life.

Many patients feel these ongoing issues are not given enough time or support during standard clinic appointments. The IBD-BOOST project was created by researchers, doctors, and patients working together to address this gap. They developed a dedicated online programme that uses practical approaches, including cognitive behavioural techniques, to help people regain confidence and better manage their daily symptoms.

This trial compares the online programme with usual NHS care to see if digital self-management really makes a noticeable difference to quality of life. If the results are positive, this kind of online support could eventually be offered across the NHS, giving people with IBD a convenient and reliable way to get help from home.

Key takeaways

Tests an 11-session online programme to help manage IBD fatigue, pain, and bowel urgency.
Completely home-based, using a computer or mobile device with no hospital travel required.
Open to adults with IBD in England, Scotland, or Wales who completed the earlier IBD-BOOST survey.
Participants are randomly split between immediate access with facilitator support and usual care (with access after 12 months).
Does not replace your regular medical care, prescriptions, or NHS clinic visits.

Who may be eligible?

To join this study, you must be 18 years or older and have a confirmed medical diagnosis of IBD. This includes people who have an ileo-anal pouch or a stoma. You must live in England, Scotland, or Wales, and you will need a smartphone, tablet, or computer with internet access.

Because this is the final phase of a wider research project, you must have already taken part in the earlier IBD-BOOST Stage 2 survey. You also need to have rated your fatigue, tummy pain, or bowel urgency as having a moderate-to-high impact on your life (a score of 5 or higher on a scale of 0 to 10).

You cannot take part if you have certain new or unexplained symptoms, known as 'red flags'. These include sudden unexplained weight loss, persistent vomiting, or new rectal bleeding that your doctor has not checked yet. If a doctor checks these symptoms and confirms it is safe, you may be able to be re-assessed for the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 18 or older.
I have a medical diagnosis of IBD (including with a stoma or pouch).
I live in England, Scotland, or Wales.
I completed the earlier IBD-BOOST Stage 2 survey.
I experience tiredness, gut pain, or bowel urgency that scores 5 or more out of 10 for impact on my life.
I do not have new, uninvestigated symptoms like sudden weight loss, frequent vomiting, or new bleeding.

Answer every question to see your result.

What does participation involve?

Taking part is done entirely from home, so you will not need to travel to extra hospital visits. After signing up online, you will complete a set of health questionnaires. If you did not do so in an earlier stage of the project, you may also be asked to post a small stool sample to check for active gut inflammation.

A computer system will then place you into one of two groups by chance. If you are placed in the programme group, you will get access to 11 online sessions that you can complete at your own pace over several months (around 1 to 2 hours per week). A trained facilitator will support you with a phone call and website messages during your first three months. If you are in the usual care group, you continue your standard NHS treatment as normal, and you will receive access to the online programme after 12 months.

Both groups will be asked to fill in follow-up questionnaires at 6 months and 12 months. As a thank you for your time, you will receive a £5 gift voucher after completing each follow-up questionnaire.

Potential risks and benefits

Taking part may help you learn useful techniques to manage pain, tiredness, and bowel urgency, which could improve your daily wellbeing. The stool test may also offer reassurance by checking whether your bowel has active inflammation. The main risk is that answering detailed questionnaires about your health may feel tiring or bring up difficult emotions. To support you, the study provides links to trusted support helplines, such as Crohn's & Colitis UK. Your participation is completely voluntary, and you can withdraw at any time without your regular NHS care being affected.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

London North West University Healthcare NHS Trust
City only
Middlesex, England
Nottingham University Hospitals NHS Trust
City only
Nottingham, England
St Helens and Knowsley Teaching Hospitals NHS Trust
City only
Prescot, England

Common questions

Do I have to change or stop my usual IBD medications?

No. You will continue taking all your prescribed medications and attend your usual NHS appointments just as you normally would.

Will I have to travel to any hospital appointments for the study?

No. The entire study takes place remotely. You complete all sessions and questionnaires online, and any stool samples are sent by post.

What happens if I am put into the usual care group?

You will carry on with your normal NHS treatments. After 12 months, you will be given free access to the online self-management programme, although without facilitator support.

How much time does the online programme take?

The programme has 11 sessions. Most people spend about one to two hours per week working through the materials and exercises over a few weeks or up to six months.

What should I do if my symptoms suddenly get worse during the study?

If you experience new or worsening symptoms, such as new bleeding or severe pain, you should contact your usual IBD clinical team or GP straight away.

How to find out more

Laura Miller

l.miller@qmul.ac.uk +44 (0)207 848 3318 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.