Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02542917 |
| Other study ID # |
15/WA/0518 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 2015 |
| Est. completion date |
August 2016 |
Study information
| Verified date |
April 2023 |
| Source |
King's College Hospital NHS Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This trial will test, in a representative group of IBD patients, the acceptability of - and
adherence to - the IBDoc test (a new home test for faecal calprotectin in the monitoring of
inflammatory bowel disease (IBD)).
Description:
Crohn's disease (CD) and ulcerative colitis (UC) are forms of inflammatory bowel disease
(IBD) that require long-term monitoring. People with these conditions require regular and
repeat testing, sometimes with endoscopy, to assess the state of the disease. Many centres
worldwide now use a stool test called faecal calprotectin (FCALP) as an accurate reflection
of endoscopic disease activity - meaning that people with IBD do not need 'routine' endoscopy
to assess their disease. FCALP can also be used to give a prediction of what will happen to a
person's IBD in the near future.
As such, FCALP is an excellent and highly cost-effective test in IBD. However, uptake is
often low (as with all stool tests) particularly because the sample needs to be taken at home
and delivered in to the laboratory or hospital to be tested. People still therefore need to
make an effort to submit samples and find this inconvenient. Furthermore, treatments for IBD
are increasingly being given at home (usually self-administered injections). While beneficial
for people with IBD, it is more difficult to keep track of such patients in the hospital
service as they attend less regularly. A test that can be done at home, while making results
available to the hospital team, is therefore desirable.
New technology allows reliable testing of FCALP at home, using a smartphone app (IBDoc-TM,
Buhlmann Laboratories) within a few minutes. The test kit is packaged with everything
required (including gloves, sample 'capture' paper, disposal bag, etc). An instructional
video is available within the app itself.
Apart from testing whether patients adhere to the testing schedule, the investigators will
also compare their experiences of the IBDoc test, health anxieties, locus of control, and
satisfaction vs postal and traditional 'drop-off' test. Validated questionnaires will
include: GAD7, PHQ9, IBDC, CBRQ and MHLC as well as a proprietary satisfaction questionnaire
at the end of the study.
