Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: 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.
Brief Summary: 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.


Options:
A: Arm Label: Adacolumn; Type: ACTIVE_COMPARATOR; Interventions: Device: Adacolumn | Arm Label: Sham; Type: SHAM_COMPARATOR; Interventions: Device: Sham | Intervention Type: DEVICE; Name: Adacolumn; Assigned to Arm(s): Adacolumn | Intervention Type: DEVICE; Name: Sham; Assigned to Arm(s): Sham
B: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: adalimumab | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: ciprofloxacin | Intervention Type: DRUG; Name: adalimumab; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: ciprofloxacin; Assigned to Arm(s): 2
C: Arm Label: Intervention group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Psychoeducational programme, Other: Standard care | Arm Label: Control group; Type: PLACEBO_COMPARATOR; Interventions: Other: Standard care | Intervention Type: BEHAVIORAL; Name: Psychoeducational programme; Assigned to Arm(s): Intervention group | Intervention Type: OTHER; Name: Standard care; Assigned to Arm(s): Control group, Intervention group
D: Arm Label: 003; Type: EXPERIMENTAL; Interventions: Other: infliximab (IFX) infusion; azathioprine (AZA) caps | Arm Label: 001; Type: EXPERIMENTAL; Interventions: Drug: infliximab (IFX) placebo infusion; azathioprine (AZA) caps | Arm Label: 002; Type: EXPERIMENTAL; Interventions: Biological: infliximab infusion; AZA placebo caps | Intervention Type: BIOLOGICAL; Name: infliximab infusion; AZA placebo caps; Assigned to Arm(s): 002 | Intervention Type: OTHER; Name: infliximab (IFX) infusion; azathioprine (AZA) caps; Assigned to Arm(s): 003 | Intervention Type: DRUG; Name: infliximab (IFX) placebo infusion; azathioprine (AZA) caps; Assigned to Arm(s): 001

Answer: C