Home Versus Postal Testing for Faecal Calprotectin: a Feasibility Study

NCT ID: NCT02542917

Last Updated: 2023-04-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 54 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-08-31

Brief 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)).

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.

Conditions

Inflammatory Bowel Diseases; Crohn's Disease; Ulcerative Colitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

All patients

IBDoc home test for faecal calprotectin

IBDoc home test for faecal calprotectin

Intervention Type: DEVICE

IBDoc home test for faecal calprotectin

Interventions

IBDoc home test for faecal calprotectin

IBDoc home test for faecal calprotectin

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King's College Hospital NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bu'Hussain Hayee

Role: PRINCIPAL_INVESTIGATOR

King's College Hospital NHS Trust

Other Identifiers

15/WA/0518

Identifier Type: -

Identifier Source: org_study_id