FI intervention study (FINS)

  • Research type

    Research Study

  • Full title

    Improving continence in people with inflammatory bowel disease: active case finding and a randomised controlled trial

  • IRAS ID

    154290

  • Contact name

    Christine Norton

  • Contact email

    christine.norton@kcl.ac.uk

  • Sponsor organisation

    London North West Healthcare NHS Trust

  • Duration of Study in the UK

    2 years, 5 months, 30 days

  • Research summary

    Inflammatory Bowel Disease (IBD) affects 250,000 adults in the UK. More than 62,000 people with IBD experience extremely distressing faecal incontinence (FI). Even in remission, many worry about not finding a toilet in time which limits their activities and negatively affects quality of life. The NHS (NICE 2007) guidance recommends that doctors and nurses actively ask all patients likely to experience FI about the symptom, and then follow a step-wise care plan for managing it. Our clinical and research experience suggests that IBD specialist doctors and nurses do not actively ask patients about FI. Most patients avoid asking for help even when they have frequent FI, so care plans for managing the symptom are not set up.

    To address this, we will work with four expert centres to deliver three linked studies:
    [1] Actively asking people with IBD, either directly during a clinic appointment or via a postal survey, if they have FI and if they would like help for it. We will show which method of being asked about FI is preferred, and which results in more people requesting help for FI.
    [2] A randomised trial comparing two different treatments. Participants will either have an IBD nurse-specialist-led intervention OR a self-help booklet, for 3 months. We will see which one produces the best results by reducing FI, other symptoms, and costs, and improving quality of life 6 months after the start of the trial. Booklet group participants will be offered the nurse intervention after 6 months if they wish.
    [3] Interviews with patients and staff on their experiences, opinions and preferences of receiving or delivering the intervention.

    Having gained sound evidence on demand for help, effectiveness of interventions, and patient and staff views on treatments, we will take active steps to ensure successful treatments are offered through the NHS.

  • REC name

    London - Hampstead Research Ethics Committee

  • REC reference

    15/LO/0051

  • Date of REC Opinion

    16 Jan 2015

  • REC opinion

    Favourable Opinion