Pilot Study of Patient Directed Monitoring of Crohn's Disease
Research type
Research Study
Full title
Pilot Study of Patient Directed Monitoring of Crohn's Disease
IRAS ID
214487
Contact name
James Turvill
Contact email
Sponsor organisation
York Teaching Hospital
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
This pilot study aims examine the feasibility and acceptability of patients self-monitoring their Crohn’s Disease in addition to their usual care.
The presence of Faecal Calprotectin (FC) in stool is a sensitive indicator of intestinal inflammation. The measurement of FC now forms part of a validated guideline widely used to support clinical decision-making and the nurse-led care of many patients diagnosed with Crohn’s disease. Whilst effective this monitoring remains rigid and focussed on optimising care resource rather than being responsive to the individual needs of patients.
The aim of this study is to investigate whether a more flexible, patient centred approach to monitoring is needed and whether such an approach can be safely implemented, so allowing patients to take control of their own care pathway. This will be examined through the introduction of an additional layer of care to the existing care pathway utilising a ‘point of care test’, which has the potential to support patient directed care
Patients who have already been diagnosed with Crohn’s Disease and are being managed within the existing pathway will be eligible for the study. Following consent participants will be provided with training on how to use the additional self-monitoring package. If participants experience any cause of concern in relation to their Crohn’s disease they will be able to provide a stool sample, which will be tested for FC. The participant will be provided with the result of the test as well as advice on how to deal with their concerns. Patients will be asked to document both their concerns, whether they decide to use an additional test, the results, advice and their resulting action within a “Patient Passport”. This process can be repeated as many times as required. Participants will continue to be seen at their usual outpatient appointments. At the end of the study participants will be asked to complete an electronic survey about their experience. 10 participants selected at random will be invited to conduct a face-to-face interview to further discuss their opinions of the study.
The study will run for approximately 12 months, funded by ForCrohns Charitable funds with participants recruited from York Teaching Hospital who are registered at a Priory Medical Group GP Practice.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
17/NE/0120
Date of REC Opinion
26 May 2017
REC opinion
Further Information Favourable Opinion