Project: Prospective multicentre cohort study to develop and validate a new mobile phone application to assess quality of life in patients with perianal and fistulating Crohn’s disease.
Year: 2016 – IN PROGRESS
Researcher: Dr Laith Alrubaiy MBChB, PhD, MRCP, MRCS, Clinical lecturer and specialty registrar in Gastroenterology and Medicine, Swansea University Medical School
The medical profession now recognises that as well as measuring survival or being disease free, it is important to measure patient reported outcome measures (PROMs) such as health-related quality of life (HRQL). HRQL is a multidimensional concept which examines the effect a disease state has on a patient’s emotional, physical, social, functional and family well-being. Crohn’s disease (CD) is a debilitating condition, with variable responses to treatment, periods of acute relapse and a high proportion of surgery. There are an increasing number of patients living with the consequences of CD and its treatment. It is therefore becoming increasingly important to measure health related quality of life to evaluate how CD affects the patient, their family and the community. CD can present as or cause perianal complications or fistulating disease which are difficult to treat and has a great impact on patients HRQL.
We have recently validated the Crohn’s and Ulcerative Colitis quality of life Questionnaire (CUCQ) as part of CONTRSUT clinical trial. CUCQ is also currently used in recording patients’ quality of life and response to treatment as part of the nationwide IBD registry. However, CUCQ was not validated in patients with Crohn’s disease who have perianal disease or fistulating disease. Therefore we propose this study to develop the first validated measure to assess the HRQL in those groups of patients and apply it as a mobile phone application to be easily used.
As part of our preliminary work, we carried out extensive literature search and focus group interviews to identify the questions that are needed to be added to the CUCQ to cover patients with perianal and fistulating disease. We defined 10 questions that cover mainly symptoms related to the perianal disease itself and/or body image. We called this new version of CUCQ as CUCQ-p ( p stands for perianal CD).
We plan to expand on our previous work to develop a smart phone application to record CUCQ-p. The application, will be called “ My IBD”, will include patients’ information leaflets about IBD and management, links to external resources like forCrohn’s and Crohn’s and Colitis UK and NHS patient information directory, and the CUCQ-p to be answered by patients. The application will have the function of emailing or printing the filled questionnaire to the IBD specialist nurse. The application will have the function to trigger annual follow-up reminder for patients who have not been in contact. We will follow the Medicines & Healthcare products Regulatory Agency (MHRA) protocol for developing new smart phone applications.
The overall aim of our study is to develop a new health related quality of life tool that can be used to assess patients with perianal and/fistulating Crohn’s disease. This new measure will be easily recorded at the point of care to support the use of a registry of patients with IBD. Specific objectives of the study are:
1. To develop and validate a short health related quality of life questionnaire to assess patients with perianal and/fistulating Crohn’s disease
2. Develop a mobile application that will enable patients with IBD to record their symptoms and monitor their disease severity.
3. Applying these measures in routine clinical practice when assessing patients with IBD e.g. in outpatient clinics, wards, telephone clinics and endoscopy.
1. Validating the CUCQ questionnaire that includes questions specific for patients with perianal and fistulating CD.
2. A mobile application that will enable patients with IBD to record their symptoms and monitor their disease severity.
We intend to disseminate our findings as widely as possible to the academic, clinical and patient community. We will work with forCrohns in order to publicise our findings through websites, newsletters and public forums such as Facebook and Twitter. We will publish study findings in high impact peer-reviewed journals. We will also present our findings at appropriate National and International Conferences such as the British Society for Gastroenterology.
To apply for a research grant please contact us at [email protected].