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临床试验/NCT02709434
NCT02709434Unknown不适用

The Efficacy of a Structured Psychoeducational Inflammatory Bowel Disease Group on the Control of Fatigue in an Adult Outpatient Setting for Patients With Objectively Quiescent Disease.

The Leeds Teaching Hospitals NHS Trust0 个研究点目标入组 40 人开始时间: 2016年12月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
主要终点
Fatigue score

研究概览

简要总结

Fatigue is a very frequently reported symptom in patients with inflammatory bowel disease (IBD), whether it is Crohn's disease (CD) or ulcerative colitis (UC). Sometimes the fatigue may be easily explained by other symptoms or tests which show that the disease is active. For example patients may be anaemic (have a low blood count) which can in itself lead to a feeling of being tired all the time. Treatment of the disease can make some of these patients feel less fatigued.

However, 4 or 5 out of every 10 patients with IBD which is felt to be in remission (ie not active disease) report fatigue. This can have far-reaching implications for patients in their everyday lives, with issues around work or school, close relationships, travel and leisure being profoundly affected. The CCUK funded research on fatigue and IBD, led by Professor Christine Norton and Wladzia Czuber-Dochan at King's College London, has identified fatigue as being a significant issue facing patients and has also highlighted that few doctors offer help and support beyond treating the disease itself when active. This is partly because fatigue itself has been difficult to measure and so any study designed to treat fatigue would be limited by being unable to quantify any improvement in a meaningful way.

Fortunately the King's College group have developed a 'fatigue score' which is a simple questionnaire that is able to quantify the severity of fatigue. The aim of our study is to assess the effect of a structured support and educational programme on the levels of fatigue in patients with inactive IBD who report moderate or severe levels of fatigue. A secondary component of our study is to see if there are any associations between fatigue levels and disease activity or other parameters such as quality of life, anxiety or symptoms of overlapping irritable bowel syndrome.

Patients will be approached in the out-patient or telephone clinics and the study will be explained with written information and any questions will be answered. If they agree to being involved they will be asked to complete the fatigue and a number of other questionnaires in addition to having the standard assessment of symptoms, blood tests and a stool specimen. Patients with active disease will be excluded from the subsequent group interventions but the data they have provided to this point will still be helpful in our understanding of fatigue in IBD. Patients identified as being in remission following the initial assessments will be offered the opportunity to be involved in the next stage of the study. The stool samples will also be analysed for the microbiome ie which bacteria are present as some studies suggest that patients with IBD may have a reduced diversity of bacteria in their intestines.

Half of this group will be randomised to active intervention and half will act as a control group for the rest of the study. The active intervention will involve completion of activity diaries over the following two weeks and then analysis of the diaries and agreement on behaviour changes designed to help fatigue. This will be supported by written information and three, monthly small group sessions to reinforce and support these changes.

At the end of the study all patients will again complete the fatigue and quality of life questionnaires and have their disease activity assessed by symptom scores, blood and stool tests. The baseline results and the final results will be analysed to see if there is any improvement in fatigue in the group undergoing the programme of support and behaviour change.

This is only a small pilot study but if it demonstrates that the intervention is feasible and may help with fatigue then a larger study will be performed to try and confirm our initial findings.

Our ultimate aim is to find a simple intervention to empower patients to deal with the difficult task of living with IBD and the fatigue that this can bring.

详细描述

Background

41%- 48% of patients with inflammatory bowel disease (IBD), which is in remission, experience fatigue (1). Fatigue is associated with significant physical, emotional, psychological and social consequences (2). This can have wide-reaching implications for patients in their everyday lives, with issues around work productivity, academic achievement, close relationships, travel and leisure being profoundly affected. Based on data from the CCUK national lottery-funded research on fatigue, although 68% of responding IBD treating professionals felt that fatigue was adequately treatable less than half offer anything over and above checking the haemoglobin level and treat if low, with only around one third offering lifestyle related advice on diet, exercise and sleep (3). The CCUK funded research on fatigue and IBD led by Professor Christine Norton and Wladzia Czuber-Dochan has not only identified fatigue as a significant issue facing patients but has also developed an objective fatigue score to quantify it. Leading on from this the King's College team has studied the role of diet and exercise in fatigue.

Aims of the proposed investigation

Our study aims to address two key questions:

  1. Do patients with active IBD have higher fatigue scores than patients with inactive disease? This question will be addressed as we will be screening a selection of patients coming to the specialist IBD clinic. Some will have active disease when assessed and so will be excluded from further interventional study. Others with inactive disease will be recruited to the study, but we will be able to compare fatigue scores in both the active and inactive disease groups. In addition we will explore any association between fatigue scores and anxiety/depression, somatisation scores, quality of life, overlapping IBS symptoms and the faecal microbiome.
  2. Can the intervention of planned behavioural change improve the symptoms of fatigue in patients with inflammatory bowel disease in remission?

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patiets with IBD in clinical and biochemical remission with no other obvious identifiable explanation for their fatigue

排除标准

  • Patients with active inflammation based on symptoms, blood tests, or stool calprotectin level will be excluded from the subsequent psychological intervention aspect of the study. Patients unable to give informed consent or who are unable to understand and follow the intervention will be excluded

结局指标

主要结局

Fatigue score

时间窗: 20 weeks

次要结局

未报告次要终点

研究者

发起方
The Leeds Teaching Hospitals NHS Trust
申办方类型
Other
责任方
Sponsor

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