You have been invited to take part in this research study. Before you decide, it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully. Ask us if there is anything that is not clear or if you would like further information.
What is the purpose of this study?
Stress is sometimes associated with the experience of Inflammatory bowel disease such as Crohn's or colitis. So far there has been little research investigating how various aspects of stress affect people and the way they cope. Initially this study will examine the way emotions, perceptions and behaviour affect the symptoms and quality of life for people with bowel problems.
Why have you been invited?
You have been invited because you are over 18 years of age and have been diagnosed with Crohn's disease or ulcerative colitis. We are asking 1000 people to take part.
Do I have to take part?
No. It is entirely up to you whether or not to take part. A decision not to take part will not affect the standard of care you receive now or in the future. If you decide to take part you are still free to withdraw at any time by asking us to remove your answers from the study and without giving a reason. Again, this will not, in any way, affect the standard of care you receive.
What will the study involve?
This study is in two parts, A & B. Part A involves you answering all of the questions below, this will take approximately 25 minutes. Then in 12 weeks time we would like you to answer some more questions, this is part B of the study. It contains some of the same questions as before but a lot less of them, this will take about 15 minutes to complete. We will write to you to remind you to do this nearer the time. These questions will ask you about how you feel, think, cope and function with your bowel problems.
We would also like to know if you would be willing to potentially talk to one of the researchers about this. If you choose to take part in this stage of the study a member of the research team will interview you over the phone and will ask a variety of questions about your bowel problems. This will be a conversation between you and the researcher only, no one else will be present. You will be asked to indicate your choice further down this page.
What happens if I take part?
Part A : You will be asked to complete the questionnaires below. In 12 weeks time we will write to you again and ask you to complete a smaller selection of these questionnaires.
You will also be asked to indicate your consent to taking part in this study and to possibly being interviewed. If you are selected for the interview stage of this study we will write to you and arrange a convenient time to carry this out over the phone. It will take a maximum of one hour.
The responses from your questionnaires and/or interview will be put onto a database. Your name and any other features that could identify you will not be included on the questionnaires or database. We will use a code instead that will link your name on a list held separately from all research information.
What are the possible disadvantages of taking part?
As you are being asked about stress and other feelings you might have about your bowel problems, it is possible that you might feel upset when completing the questionnaires. If you should feel this way then you can contact Cheryl Jordan (Cheryl.firstname.lastname@example.org 02078483285) to discuss this and the possibility of accessing longer term support.
What are the benefits of taking part?
Apart from possibly identifying that you have a need for further healthcare, this research will have no direct benefit to you. Nevertheless, once we have completed our study with a sufficient number of patients, we will combine as much information as possible, and publish our results. In this way, research results will be made available to the medical and scientific community and will enhance our understanding of how the mind may interact with the physical symptoms of IBD and hence inform development of appropriate psychosocial treatment in the near future.
What if something goes wrong?
In the unlikely event you are harmed by taking part in this research project, there are no special compensation arrangements. If you are harmed due to someone's negligence, then you may have grounds for legal action but you may have to pay for it. Regardless of this, if you wish to complain, or have any concerns about any aspect of the way you have been approached or treated during the course of this study, the normal National Health Service complaints mechanisms should be available to you.
Will my taking part in this study be kept confidential?
All information which is collected about you during the course of this research programme will be kept strictly confidential.
What will happen to the results of this study?
We will publish the results so that as many of our findings as possible will be made available to the medical and scientific community. You will not be personally identified in any publication (i.e. your name and identity will not be mentioned in any report of the findings). Any data, information or quotes used in any publications which arise from this study will be anonymised. The timing of any publication will depend mostly on the speed with which we collect data and cannot be predicted with certainty.
Who is organising and funding the research?
The study is being organised by Cheryl Jordan lecturer at King's College London in conjunction with Dr Bu'Hayee, Consultant Gastroenterologist at King's College Hospital NHS Foundation Trust. We are not paid for including you in this study.
Who has reviewed this study?
This study has been reviewed by the National Research Ethics Service, NRES Committee London - Bloomsbury.
Contact for further information
Cheryl Jordan Florence Nightingale School of Nursing and MidwiferyKing's College LondonJames Clerk Maxwell Building57 Waterloo RoadLONDON, SE1 8WA