IBD Self-management Website and Home Faecal Calprotectin Monitoring

Ulcerative Colitis Clinical Trial

Official title: Feasibility and Acceptability of an Inflammatory Bowel Disease Self-management Website and Home Faecal Calprotectin Monitoring After Treatment De-escalation

Status Completed

Clinical Trial Summary

6 month exploratory feasibility study to assess if a combination of MyMedicalRecord supported self-management website and a home faecal calprotectin smartphone testing kit is a feasible and acceptable means for patients to monitor for signs of relapse after treatment de-escalation.

Clinical Trial Description

IBD can be challenging to manage as disease flares are often unpredictable and rarely coincide with scheduled outpatient appointments. Websites are a novel way of assisting patients to take more control over monitoring and managing symptoms and have been shown to improve outcomes in some chronic diseases. The My Medical Record (MyMR) webiste was developed to help patients learn about IBD, access test results, monitor symptoms, and manage their medications, with email support from the IBD team.

The use of home faecal calprotectin monitoring will also be explored. This marker of IBD activity is normally performed in hospital laboratories and becomes elevated before the onset of clinical symptoms of an IBD flare. New technologies enable patients to perform the test at home with the aid of a smartphone application.

A 6 month exploratory feasibility study will be conducted to assess if a combination of MyMR and a home faecal testing kit is a feasible and acceptable means for patients to monitor their illness. Their use will be targeted to patients who have recently stopped (or reduced) a treatment for IBD, as up to 50% of these patients may have a disease flare within a year.

Interventions

• Clinic appointments Study participants will not be required to attend any routine outpatient follow up appointments for the 6 month study period, after which they will be reviewed by a member of the IBD team.

• Questionnaires and interviews Partcipants will receive questionnaires and a sample will also undergo interviews to explore their views regarding the website and stool test.

• Website

Participants will be encouraged to use all functions of the website at least monthly:

1. Secure email messaging service

2. IBD educational material

3. Stool, nutritional and flare journals

4. Blood and test results

5. Faecal calprotectin monitoring - monthly testing (or sooner if symptoms of a flare-up) using QuantonCal home faecal calprotectin smartphone application. Participants will test and monitor their FC levels monthly. The results will be overseen by the IBD team who will make contact within a week in the event of abnormal results if the participant has not already done so.

• Blood tests All participants will have a routine blood test at 0 and 6 months. Those taking azathioprine, mercaptopurine and methotrexate should continue regular blood monitoring (minimum of 3 monthly FBC, U&E, LFT and CRP) as usual practice. Participants will be provided with blood test results and explanations of their significance via MyMR. The results will be overseen by the IBD team who will make contact within a week in the event of abnormal results if the patient has not already done so.

• Safety Patients can contact the IBD team the email messaging service at any time for advice and support. ;

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Crohn Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Self-care
• Ulcerative Colitis

• NCT number: NCT03671980
• Study type: Interventional
• Source: University Hospital Southampton NHS Foundation Trust
• Status: Completed
• Phase: N/A
• Start date: April 4, 2017
• Completion date: June 30, 2018