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RecruitingNot SpecifiedInterventional

Redesigning a faster pathway to inflammatory bowel disease (IBD) diagnosis

This study, called RAPID-1, wants to improve how quickly people are diagnosed with Inflammatory Bowel Disease (IBD), a long-term gut condition. Many people with IBD experience symptoms for over a year before receiving a diagnosis, often due to worries about seeing a doctor or having invasive tests. The study has two parts. The first part explores why diagnosis takes so long. The second part tests if offering a simple, free home stool test directly to people with ongoing gut symptoms can help identify IBD earlier. This could mean getting help and treatment sooner, potentially improving health outcomes for those with the condition.

At a glance

Status
Recruiting
Phase
Not Specified
Sponsor
Royal Devon University Healthcare NHS Foundation Trust
Enrolment target
5,000
Start
12 Jun 2024
Estimated completion
01 Sep 2026

What is this study about?

Inflammatory Bowel Disease (IBD) is a condition that affects your gut, causing symptoms like tummy pain, diarrhoea, and bleeding. Many people wait a long time, often over a year, before they find out they have IBD. This can happen for different reasons, such as feeling embarrassed about their symptoms or being worried about medical tests. This study wants to make this journey faster and easier.

The study has two main parts. The first part, called RAPID-1, talks to people who have recently been diagnosed with IBD. It aims to understand their experiences and figure out what made their diagnosis take so long, and what might have stopped them from seeking help earlier. This information is important for improving the diagnosis process for others in the future.

The second part of the study, RAPID-2, is looking at a new way to diagnose IBD. It's testing whether sending a simple stool (poo) test directly to people who have ongoing gut symptoms could help identify IBD earlier. If the test suggests IBD, those people would then be offered further checks and support. The hope is that this direct approach could cut down the waiting time for a diagnosis.

Key takeaways

  • Aims to speed up IBD diagnosis.
  • Investigates why diagnosis is currently slow.
  • Tests directly-sent home stool kits.
  • Could lead to earlier care for IBD.
  • Involves questionnaires or a home test kit.
  • Risks are minimal, mostly discomfort.

Who may be eligible?

This study has different groups depending on what part you might take part in.

For the first part (RAPID-1), you can join if you're aged 16 or over and have been diagnosed with IBD within the last 30 days. You'll need to be able to understand the study and agree to take part.

For the second part (RAPID-2), you can take part if you're aged 16 to 49, live in the Royal Devon area (which is where the study is based), and have had tummy symptoms for more than two weeks. These symptoms could include lower tummy pain, diarrhoea, or bleeding. You also shouldn't have had specific camera tests for your gut (a flexible sigmoidoscopy or colonoscopy) in the last two years.

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.

  1. Are you 16 years old or over?
  2. Have you been diagnosed with IBD in the last 30 days (for RAPID-1)?
  3. Do you live in the Royal Devon area and have tummy symptoms for more than 2 weeks (for RAPID-2)?
  4. Have you NOT had a camera test (flexible sigmoidoscopy or colonoscopy) in the last two years (for RAPID-2)?
  5. Are you willing for researchers to access your health records for one year for follow-up?
Answer every question to see your result.

What does participation involve?

If you join the first part (RAPID-1) of the study, you'll be asked to fill in some questionnaires about your health, how you're feeling, and how your symptoms affect your daily life. Some people might also be invited for an interview to talk about their experience of getting diagnosed. These would be one-off activities.

If you join the second part (RAPID-2), you'll receive a kit in the post for a stool (poo) test. You'll collect a small sample at home and send it back to a lab. If your test results show signs of inflammation or blood, you'll get a phone call and be offered further tests to investigate. Everyone in this part of the study will be followed up for a year to see how their health progresses. The total time for follow-up would be one year.

Potential risks and benefits

Taking part in this study could help improve how IBD is diagnosed for everyone in the future. For those in the second part of the study, an earlier test result showing signs of IBD could lead to getting further medical care sooner. The risks involved are generally low. Some people might feel a bit uncomfortable collecting a stool sample at home or discussing personal health details, but the study team will provide support. Remember, you have the right to withdraw from the study at any time without giving a reason.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Royal Devon University Healthcare NHS Foundation Trust
    City only
    Exeter, United Kingdom

Common questions

What is Inflammatory Bowel Disease (IBD)?

IBD is a long-term condition that causes inflammation in your gut, leading to symptoms like tummy pain, diarrhoea, and bleeding.

Why is this study important?

This study aims to help people get diagnosed with IBD more quickly, which could mean they get the right treatment and support sooner.

What is a stool test?

A stool test involves collecting a small sample of your poo at home and sending it to a lab to look for signs of inflammation or other issues.

Do I need to see my doctor to get a test kit?

For the second part of the study (RAPID-2), you can request a free stool test kit directly online without needing to see a doctor first.

Who is funding this research?

The study is being funded by the National Institute for Health and Care Research (NIHR), a major health research funder in the UK.

How to find out more

Claire Bewshea

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

Discussion

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