Home Versus Postal Testing for Faecal Calprotectin: a Feasibility Study

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)).

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases; Crohn's Disease; Ulcerative Colitis
• Intervention / Treatment: Device: IBDoc home test for faecal calprotectin

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 54

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Unselected patients with any form of inflammatory bowel disease on any treatment and at any stage of disease activity (diagnosed more than 6 months prior to study entry)

Description

Inclusion Criteria:

• Patients with inflammatory bowel disease diagnosed at least 6 months prior to study entry
• Willing to participate in home testing and have smartphone
• Able to understand English or explanation via interpreter, and provide written consent

Exclusion Criteria:

• Participants without smartphone (Android or iOS)
• Unable to understand English (excl. via interpreter)
• No previous experience of submitting stool samples for faecal calprotectin measurement

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All patients; IBDoc home test for faecal calprotectin	Device: IBDoc home test for faecal calprotectin; IBDoc home test for faecal calprotectin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to testing schedule (overall >75%)	As this is a feasibility study there is no 'outcome' measure as such; We are testing the adherence to the study protocol as the main outcome of this study	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Any change in health locus of control score	Any change in MHLC score from study start to end	6 months
Any change in cognitive behavioural response score	Any change in CBRQ-32 score from study start to end	6 months

Collaborators and Investigators

• Sponsor: King's College Hospital NHS Trust
• Investigators: Principal Investigator: Bu'Hussain Hayee, King's College Hospital NHS Trust

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: May 29, 2015
• First Submitted That Met QC Criteria: September 4, 2015
• First Posted (Estimate): September 7, 2015

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: 15/WA/0518