Improving Continence in People With Inflammatory Bowel Disease: Active Case Finding and a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 6
- 主要终点
- The St Mark's faecal incontinence score (0-24 scale)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
排除标准
- •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
研究组 & 干预措施
Group 1 (IBD Nurse CONSULT + BOOKLET)
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
干预措施: IBD nurse intervention (Other)
Group 2 (BOOKLET alone)
Will receive the same booklet and access to usual care as Group 1.
结局指标
主要结局
The St Mark's faecal incontinence score (0-24 scale)
时间窗: 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
次要结局
- Inflammatory Bowel Disease - Quality of Life (IBD-Q)(At 6 months from recruitment)
- Simple Clinical Colitis Activity Index (SCCAI)(At 6 months from recruitment)
- Measure Yourself Medical Outcome Profile (MYMOP 2)(At 6 months from recruitment)
- The Brief Illness Perception Questionnaire (BIPQ)(At 6 months from recruitment)
- International Consultation on Incontinence - Inflammatory Bowel Disease (ICIQ-IBD)(At 6 months from recruitment)
- Study specific tool: Health economics(At 6 months from recruitment)
- Medical record of escalation of treatment(Up to 6 months from recruitment)
- Harvey Bradshaw Index (HBI)(At 6 months from recruitment)
- European Quality of Life - 5 Dimensions (EQ-5D)(At 6 months from recruitment)
- Study-specific tool: Global perception of change(At 6 months from recruitment)