Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-02 @ 8:40 PM
Study NCT ID:
NCT02355834
Status:
COMPLETED
Last Update Posted:
2018-08-28
First Post:
2014-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Faecal Incontinence iNtervention Study
Sponsor:
London North West Healthcare NHS Trust
Organization:
Study Overview
Official Title:
Improving Continence in People With Inflammatory Bowel Disease: Active Case Finding and a Randomised Controlled Trial
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FINS
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: