Fecal IncontinenceFINSNCT02355834
Faecal Incontinence iNtervention Study
A study testing IBD nurse intervention in people with Fecal Incontinence and Inflammatory Bowel Disease (IBD), run by London North West Healthcare NHS Trust at 6 sites in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fecal Incontinence, Inflammatory Bowel Disease (IBD)
- What is being tested?
- IBD nurse intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- May 2015to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Kingdom6 sites
St. Marks Hospital (London North West Healthcare NHS Trust)
Harrow, London, HA1 3UJ
Queen Elizabeth II Hospital
Kings Lynn, Norfolk, PE30 4ET
Bart's Health NHS Trust
London, E1 1BB
Royal Free Hospital
London, NW3 2QG
Guy's & St Thomas' NHS Foundation Trust
London, SE1 7EH
John Radcliffe Hospital (Oxford University Hospitals NHS Trust)
Oxford, OX3 9DU
About this study
Official title: Improving Continence in People With Inflammatory Bowel Disease: Active Case Finding and a Randomised Controlled Trial
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.
Read the 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:
- 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.
- 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.
- 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.
- Being tested
- IBD nurse intervention
- Keywords
- Fecal Incontinence (FI), Inflammatory bowel disease (IBD), bowel control, Chronic diarrhoea, rectal inflammation
- Medical subject headings
- Fecal Incontinence, Inflammatory Bowel Diseases, Proctitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBD nurse interventionOther
Two IBD nurse specialists at each centre (8 in total) will deliver the IBD nurse intervention
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (IBD Nurse CONSULT + BOOKLET) | Experimental | IBD nurse intervention-Will have 3-4 x 30 minute face-to-face sessions over 3 months with an IBD specialist nurse specifically focusing on bowel control. Participants completing at least 3 sessions will be considered to have completed the intervention. They will also be given a booklet and access to all usual care, including nurse-led IBD helpline Receives: Other: IBD nurse intervention |
| Group 2 (BOOKLET alone) | No intervention | Will receive the same booklet and access to usual care as Group 1. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The St Mark's faecal incontinence score (0-24 scale)
Self-reported incontinence and protection (medications, use of incontinence pads) score. Four items are scored 0 - 4 (0 = never, 4 = daily) and three items are scored as 0 (No), or 2 or 4 (Yes). This yields an overall score of 0 - 24, a higher score indicating greater incontinence problems
Measured: At 6 months from recruitment
Secondary outcomes (10)
International Consultation on Incontinence - Inflammatory Bowel Disease (ICIQ-IBD)
Self-reported questionnaire. Participants provide an 'in remission' and / or an 'in relapse' score of 0 - 4 across 35 items in 3 domains: Domain A (IBD-FI symptoms) - 11 questions yield an overall score of 0 - 46; Domain B (IBD-FI Quality of Life) - the 14 questions yield an overall score of 0 - 56; Domain C (Other concerns) - the 10 questions yield an overall score of 0 - 42. In all domains, a higher score indicates worse symptoms, quality of life (QoL), or concerns. In each domain, subtracting the remission score from the relapse score reveals variation in symptoms, QoL and concerns between these two disease states. A higher variation score indicates greater fluctuation of these issues for the patient. This outcome measure has been developed by two of the study team and is being further tested / validated here.
Measured: At 6 months from recruitment
Inflammatory Bowel Disease - Quality of Life (IBD-Q)
Self-reported IBD quality of life questionnaire. Respondents select one option from seven available, scored from 1 to 7 across 32 questions. This yields an overall score of 32 (high impact on quality of life) to 224 (low impact on quality of life. A higher overall score equals better quality of life. Responses can also be calculated across four different domains of: Bowel systems, emotional health, systemic systems, and social function, following instructions provided by the copyright holder.
Measured: At 6 months from recruitment
Harvey Bradshaw Index (HBI)
Modified screening questionnaire to enable patient self-completion. Collects information about classic disease symptoms of Crohn's disease and extra-intestinal features. Scores of up to 4 indicate clinical remission, scores of 5 and over indicate relapse.
Measured: At 6 months from recruitment
Simple Clinical Colitis Activity Index (SCCAI)
Modified screening questionnaire to enable patient self-completion. Collects information about classic disease symptoms of Ulcerative colitis and extra-intestinal features. Scores of up to 4 indicate clinical remission, scores of 5 and over indicate relapse.
Measured: At 6 months from recruitment
Measure Yourself Medical Outcome Profile (MYMOP 2)
Participants set 2 goals for intervention, grading goals at baseline and then re-scoring after intervention, giving an individualised profile of the most bothersome symptom
Measured: At 6 months from recruitment
European Quality of Life - 5 Dimensions (EQ-5D)
Self-reported quality of life [QoL] scale; participants indicate their current capabilities by selecting one of five options, across 5 domains: Mobility, Self-care, usual activities, pain or discomfort, and anxiety or depression. Option 1 is scored as '1' , option 5 is scored as '5'. This yields a total score of 5 - 25, a higher score indicating greater health problems. Respondents also indicate, on a 0-100 scale, how good or bad their health is on the day of completion. '0' = the worst health imaginable, whilst 100 = the best health imaginable.
Measured: At 6 months from recruitment
The Brief Illness Perception Questionnaire (BIPQ)
The participant responds to eight questions about their condition, and the impact this has on them. Questions 1,2,5, 6 \& 8 are scored 0 (no impact / effect) to 10 (Great impact / effect), yielding a total score of 0 - 50, a higher score indicates greater impact. Questions 3, 4 \& 7 are scored 0 (no control, help from treatment or understanding) to 10 (great amount of control, help from treatment, and understanding) yielding a total score of 0 - 30, a lower score indicates worse control, help from treatment, and understanding. Finally, the participant identifies three factors which they believe to have contributed towards their health problem.
Measured: At 6 months from recruitment
Study specific tool: Health economics
The participant reports interactions with health care professionals and investigative procedures (in addition to any required for the study), hospital visits / stays; any equipment, medication, travel or work-absence costs endured during the study period
Measured: At 6 months from recruitment
Study-specific tool: Global perception of change
Participants report whether they feel their incontinence has got worse, stayed the same or improved. The also indicate which of the interventions offered to them via the study's self-management booklet were taken up, and how easy or difficult these were to comply with, or use. There is also an opportunity to provide free text responses about their experience of the intervention. Response options are not scored, and there is no overall score for this tool. It is used to assess the impact, usefulness and acceptability of the offered interventions, in order to inform future service delivery.
Measured: At 6 months from recruitment
Medical record of escalation of treatment
Records changes (increases) in medical or surgical treatment during the course of the intervention as this may confound outcomes for the participant, or lead to withdrawal from the study.
Measured: Up to 6 months from recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2015 (estimated)
- Study startMay 2015
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- London North West Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary University of London, King's College London
- Responsible party
- Sponsor
- Investigators
- Christine Norton, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02355834
- Sponsor's protocol ID
- RD14/042
- Acronym
- FINS
- Status last verified
- Aug 2018
- First submitted
- 12 Dec 2014
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26445224
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Continence in People With Inflammatory Bowel Disease: Active Case Finding and a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02355834
- Acronym / sponsor ID
- FINS / RD14/042
- Keywords
- Fecal Incontinence (FI), Inflammatory bowel disease (IBD), bowel control, Chronic diarrhoea, rectal inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- London North West Healthcare NHS TrustUniversity, hospital or other
- Collaborators
- Queen Mary University of London, King's College London
- Study start
- May 2015
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 4 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (IBD Nurse CONSULT + BOOKLET) | Experimental | Other: IBD nurse interventionIBD nurse intervention-Will have 3-4 x 30 minute face-to-face sessions over 3 months with an IBD specialist nurse specifically focusing on bowel control. Participants completing at least 3 sessions will be considered to have completed the intervention. They will also be given a booklet and access to all usual care, including nurse-led IBD helpline |
| Group 2 (BOOKLET alone) | No intervention | –Will receive the same booklet and access to usual care as Group 1. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IBD nurse interventionTwo IBD nurse specialists at each centre (8 in total) will deliver the IBD nurse intervention | Other | Group 1 (IBD Nurse CONSULT + BOOKLET) |
Primary outcome
The St Mark's faecal incontinence score (0-24 scale)
Time frame: At 6 months from recruitment
Self-reported incontinence and protection (medications, use of incontinence pads) score. Four items are scored 0 - 4 (0 = never, 4 = daily) and three items are scored as 0 (No), or 2 or 4 (Yes). This yields an overall score of 0 - 24, a higher score indicating greater incontinence problems
10 secondary outcomes
International Consultation on Incontinence - Inflammatory Bowel Disease (ICIQ-IBD)
Time frame: At 6 months from recruitment
Inflammatory Bowel Disease - Quality of Life (IBD-Q)
Time frame: At 6 months from recruitment
Harvey Bradshaw Index (HBI)
Time frame: At 6 months from recruitment
Simple Clinical Colitis Activity Index (SCCAI)
Time frame: At 6 months from recruitment
Measure Yourself Medical Outcome Profile (MYMOP 2)
Time frame: At 6 months from recruitment
European Quality of Life - 5 Dimensions (EQ-5D)
Time frame: At 6 months from recruitment
The Brief Illness Perception Questionnaire (BIPQ)
Time frame: At 6 months from recruitment
Study specific tool: Health economics
Time frame: At 6 months from recruitment
Study-specific tool: Global perception of change
Time frame: At 6 months from recruitment
Medical record of escalation of treatment
Time frame: Up to 6 months from recruitment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Derived from this study: PubMed 26445224Norton 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Norton, PhD principal investigator
King's College London
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IBD nurse intervention in people with Fecal Incontinence and Inflammatory Bowel Disease (IBD), run by London North West Healthcare NHS Trust at 6 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The St Mark's faecal incontinence score (0-24 scale) (time frame: At 6 months from recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02355834, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2018.