Feasibility of SSM website and FC in IBD
Research type
Research Study
Full title
Feasibility and acceptability of an inflammatory bowel disease self-management website and home faecal calprotectin monitoring
IRAS ID
214907
Contact name
Nicola Taylor
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
Crohn’s and ulcerative colitis (known as inflammatory bowel disease (IBD)) affect 620,000 people in the UK. IBD causes distressing symptoms like diarrhoea and pain. Treatments for IBD are costly and can have serious side effects. It can be difficult to decide when to stop treatment due to the risk of serious disease 'flares' (or relapses, occurring in half of patients per year). Patients often know their disease best and one way to potentially help is to support patients in monitoring their disease themselves, whilst reducing demands on overstretched outpatient services.
We aim to assess the feasibility and acceptability of two linked self-management interventions to help patients to monitor their IBD - a self-management website called My Medical Record (MyMR)combined with at-home faecal calprotectin (FC) monitoring. MyMR provides access to test results, monitoring diaries, IBD education and a secure messaging service. FC is a stool test usually performed in laboratories, which can detect inflammation in the bowel before symptoms appear. It will instead be performed by patients using a home-testing kit and mobile phone application. We are particularly interested in providing these tools to patients who have stopped medications for any reason, as around half of these patients will experience a disease flare within one year.
We plan to conduct an exploratory feasibility study which will inform a full feasibility trial for a subsequent randomised controlled trial. Instead of attending routine outpatient clinic appointments, 30 patients will be recruited over a 6 month period and will use MyMR to monitor their symptoms, blood tests and monthly home FC levels for 6 months, all supported by their IBD team. We will then conduct questionnaires, interviews in a sample of patients, and a focus group amongst IBD nurses to evaluate the acceptability of using the website and home FC-testing.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
17/SC/0002
Date of REC Opinion
7 Feb 2017
REC opinion
Further Information Favourable Opinion