Faecal Incontinence iNtervention Study (FINS)

ClinicalTrials.gov

uk clinical trials, clinical research london

ClinicalTrials.gov Identifier:
NCT02355834

Purpose

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 four 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 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.

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Eligibility

Ages Eligible for Study:
18 Years to 80 Years
Genders Eligible for Study:
Both
Accepts Healthy Volunteers:
No
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 (scoring ≤ 4 on the relevant disease activity index)
Reporting FI at least once in the past year
With or without ileo-anal pouch plus:
Exclusion criteria:

Under 18
Current disease flare-up scoring >5 on the relevant disease activity index)
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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02355834

Contacts
Contact: Christine Norton, PhD +44 2033121795 christine.norton@kcl.ac.uk
Contact: Lesley Dibley, MPhil 020 7848 3526 lesley.b.dibley@kcl.ac.uk

Locations
United Kingdom
St. Marks Hospital (London North West Healthcare NHS Trust) Recruiting
Harrow, London, United Kingdom, HA1 3UJ
Contact: Simon Lewis 0208 869 5173 simon.lewis4@nhs.net
Contact: Fatima Zaman 0208 869 2078 fatima.zaman@nhs.net
Principal Investigator: Ailsa Hart, MD
Bart’s Health NHS Trust Recruiting
London, United Kingdom, E1 1BB
Contact: Charles Knowles, MBBChir, FRCS, PhD +44 (0) 207 882 ext 8757 c.h.knowles@qmul.ac.uk
Principal Investigator: James Lindsay, MD
Guy’s & St Thomas’ NHS Foundation Trust Recruiting
London, United Kingdom, SE1 7EH
Contact: Julie Duncan, MSc +44 (0) 20 7188 ext 2493 julie.duncan@gstt.nhs.uk
Principal Investigator: Julie Duncan, MSc
John Radcliffe Hospital (Oxford University Hospitals NHS Trust) Not yet recruiting
Oxford, United Kingdom, OX3 9DU
Contact: Lydia White, MSc +44 (0) 1865 22 ext 8772 lydia.white@ouh.nhs.uk
Principal Investigator: Lydia White, MSc

 

To apply for this job please visit the following URL: https://www.clinicaltrials.gov/ct2/show/study/NCT02355834 →