Faecal Incontinence iNtervention Study

Summary

Inflammatory Bowel Disease (IBD) affects 250,000 adults in the United Kingdom (UK) and causes bouts of diarrhoea which are hard to control. Over a quarter of patients experience extremely distressing faecal incontinence (FI). Even when the disease is in remission, the majority of patients live in fear of not finding a toilet in time. This curtails their activities and quality of life. The National Institute for Clinical Excellence (NICE 2007) has issued national guidance on actively asking patients about FI and a step-wise care plan for managing FI. However, this has not been evaluated in people with IBD, the vast majority of whom do not ask for help, even when they have frequent FI.

Across six expert centres in the UK, the investigators will perform 3 linked studies: \[1\] The investigators will screen people with IBD, offering the opportunity to obtain help with bowel control. The investigators will compare uptake of a postal approach versus response to a proactive face-to-face asking approach at a physical or telephone clinical appointment. \[2\] The investigators will conduct a randomised controlled trial (RCT) comparing two different approaches (IBD nurse specialist plus self-help booklet versus self-help booklet alone) to see which one produces the best results in terms of reductions in FI, other symptoms, costs and quality of life at 6 months after intervention. Booklet group participants may access the nurse intervention at 6 months if they wish, when the RCT is finished. \[3\] Interviews will be performed at the end of the intervention, gathering patient views and preferences and staff perspectives via Qualitative interviews and free text questionnaire comments, to enable a rich understanding and interpretation of our results.

The investigators will disseminate the results widely to people with IBD and health professionals and take active steps to embed successful interventions in NHS services, having gained sound evidence on how many people want help, whether intervention is effective in improving FI, and patient and staff views on interventions.

Conditions

• Fecal Incontinence
• Inflammatory Bowel Disease (IBD)

Interventions

OTHER

IBD nurse intervention

Two IBD nurse specialists at each centre (8 in total) will deliver the IBD nurse intervention

Sponsors & Collaborators

• Queen Mary University of London

  collaborator OTHER

• King's College London

  collaborator OTHER

• London North West Healthcare NHS Trust

  lead OTHER

Principal Investigators

• Christine Norton, PhD · King's College London

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-05-31

Primary Completion

2017-08-31

Completion

2017-08-31

Countries

• United Kingdom

Study Locations