Clinical trial NCT02355834: Faecal Incontinence iNtervention Study
Official title: Improving Continence in People With Inflammatory Bowel Disease: Active Case Finding and a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fecal Incontinence
Inflammatory Bowel Disease (IBD)
Keywords: Fecal Incontinence (FI)
Inflammatory bowel disease (IBD)
bowel control
Chronic diarrhoea
rectal inflammation
Lead sponsor: London North West Healthcare NHS Trust
Sponsor class: OTHER
Collaborators: name: Queen Mary University of London
name: King's College London
First posted: 2015-02-04
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: Inflammatory bowel disease (IBD) affects approximately 250,000 UK adults. It causes symptoms including diarrhoea and extreme faecal urgency and has an unpredictable relapsing-remitting course. A quarter of people with IBD report faecal incontinence (FI) and two-thirds have urgency, even when IBD is in remission. Although this limits peoples' lives, most do not seek professional help. No study has determined whether nationally recommended approaches to FI would help people with IBD.

Research question Does implementation of the nationally (NICE)-recommended approach to active case-finding and step-wise management of FI improve bowel control and quality of life in people with IBD.

The investigators will address 3 objectives:

1. To implement 'active case finding' for FI and life-restricting faecal urgency in people with IBD, monitoring uptake of the offer of help and investigating barriers to accessing care.
2. To determine the effectiveness of implementing the algorithm of care proposed by NICE for people with FI in a randomised controlled trial compared to provision of the same information in a self-management booklet. The trial will measure the effects of each intervention at 6 months after completion of the intervention.
3. To obtain detailed qualitative feedback from patients and staff on the best way of enabling health-seeking, the experience of the intervention and suggestions for future service developments.

Plan of investigation We will conduct research in 6 UK specialist IBD services, in two phases with an integral qualitative element.

Phase 1: active case finding: will (a) Compare active case finding rates of disclosure for FI as recommended by NICE by using a postal, telephone or face to face approach; and (b) Determine currently unmet need for intervention for FI. All hospitals will conduct postal case-finding (1000 people) and all will conduct face to face or telephone questioning (1000 people) to compare numbers reporting FI and uptake of offer of intervention.

Phase 2: randomised controlled trial 186 patients with IBD and FI will be recruited (from people wanting help in Phase 1) to a parallel multicentre RCT comparing 2 interventions: (a) CONSULT + BOOKLET: 3-4 face to face or telephone consultations with an IBD specialist nurse who has received extra training on FI plus provision of a booklet developed with IBD patients on self-help for FI; (b) BOOKLET: intervention is booklet alone.

Eligibility criteria: For active case-finding: diagnosis of IBD,between 18 and 80 years of age; diagnosis of IBD confirmed with endoscopy / colonoscopy; no stoma.

For RCT and patient interviews: Patients with IBD who experience FI, are interested in interventions, and meet the following:

Inclusion criteria:

* Endoscopically confirmed IBD diagnosis
* Between 18 and 80 years of age
* No current flare-up of disease (self-report of usual symptoms when not in active flare)
* Reporting FI at least once in the past year
* With or without ileo-anal pouch plus:

Exclusion criteria:

* Under 18 or over 80
* Current disease flare-up (self-report of usual symptoms indicative of active flare)
* Course of specialist FI treatment in past year
* Previous major anal fistula surgery (surgical lay-open) or current perianal fistula
* Current stoma
* Current participation in another trial
* Inability to give informed consent (for example, due to reduced mental capacity)
* Inability to read or speak sufficient English to understand study documents, procedures and requirements

Primary outcomes:
measure: The St Mark's faecal incontinence score (0-24 scale)
timeFrame: At 6 months from recruitment
Secondary outcomes:
measure: International Consultation on Incontinence - Inflammatory Bowel Disease (ICIQ-IBD)
timeFrame: At 6 months from recruitment
measure: Inflammatory Bowel Disease - Quality of Life (IBD-Q)
timeFrame: At 6 months from recruitment
measure: Harvey Bradshaw Index (HBI)
timeFrame: At 6 months from recruitment
measure: Simple Clinical Colitis Activity Index (SCCAI)
timeFrame: At 6 months from recruitment
measure: Measure Yourself Medical Outcome Profile (MYMOP 2)
timeFrame: At 6 months from recruitment
measure: European Quality of Life - 5 Dimensions (EQ-5D)
timeFrame: At 6 months from recruitment
measure: The Brief Illness Perception Questionnaire (BIPQ)
timeFrame: At 6 months from recruitment
measure: Study specific tool: Health economics
timeFrame: At 6 months from recruitment
measure: Study-specific tool: Global perception of change
timeFrame: At 6 months from recruitment
measure: Medical record of escalation of treatment
timeFrame: Up to 6 months from recruitment
Other outcomes:
Locations:
city: Harrow
country: United Kingdom
facility: St. Marks Hospital (London North West Healthcare NHS Trust)
state: London
city: King's Lynn
country: United Kingdom
facility: Queen Elizabeth II Hospital
state: Norfolk
city: London
country: United Kingdom
facility: Bart's Health NHS Trust
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: Guy's & St Thomas' NHS Foundation Trust
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital (Oxford University Hospitals NHS Trust)
Study officials:
affiliation: King's College London
name: Christine Norton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Norton C, Dibley LB, Hart A, Duncan J, Emmanuel A, Knowles CH, Stevens N, Terry H, Verjee A, Kerry S, Hounsome N. Faecal incontinence intervention study (FINS): self-management booklet information with or without nurse support to improve continence in people with inflammatory bowel disease: study protocol for a randomized controlled trial. Trials. 2015 Oct 6;16:444. doi: 10.1186/s13063-015-0962-0.