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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03671980
• Other study ID #: RHM MED1269
• Status: Completed
• Phase: N/A
• Start date: April 4, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: September 2018
• Source: University Hospital Southampton NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: June 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults aged = 18 years currently under secondary care outpatient follow up for IBD

• Diagnosed with IBD at least one year prior to study enrolment (to ensure patients are familiar with their disease and treatments)

• Stopped or reduced the dose of one or more treatments for IBD (for any reason) within the last 8 weeks

• Able to understand English and provide written consent.

• Own, or have regular (at least weekly) access to a smartphone +/- personal computer with internet

Exclusion Criteria:

• Inability to read, understand informed consent

• Inability to use a smartphone

• Likely requirement of IBD surgery within the study period

• Ileostomy

• Pregnancy or planned pregnancy within next 6 months

• Terminal illness with limited (< 1year) life expectancy

• Current participation in another IBD research study

• Any reason, in the opinion of the investigators, which is likely to make the patient unsuitable for the study

Related Conditions & MeSH terms

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

Intervention

Other:
• My Medical record website
Website comprising patient records, blood and other test results, useful information on IBD, and messaging service to communicate with IBD team, plus home smartphone faecal calprotectin monitoring.

Locations

Country	Name	City	State
United Kingdom	Univesity Hospital Southampton NHS Foundation Trust	Southampton	Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Southampton NHS Foundation Trust	University of Southampton

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Faecal calprotectin testing completion rates	Number of patients completing monthly faecal calprotectin testing	6 months
Primary	MyMR website usage	Number of patients logging in to MyMR website at least monthly	6 months
Secondary	Recruitment	Number of patients recruited per month	6 months
Secondary	IBD email contact	Number of email messaging contacts per patient to IBD specialist nursing team	6 months
Secondary	IBD flareline calls	Number of IBD flareline telephone calls per patient to IBD specialist nursing team	6 months
Secondary	IT support contact	Number of IT support email contacts per patient	6 months
Secondary	Questionnaire response rates	Response rates to pre-and post-study questionnaires	6 months
Secondary	Retention rate	Study retention rate (target 80%). Study retention will be defined as successful completion of at least 5 out of 7 home faecal calprotectin tests, with no periods without login to website of greater than 3 consecutive months.	6 months
Secondary	Calprotectin levels	Mean faecal calprotectin levels at 0, 4, 8, 12, 16, 20, and 24 weeks.	6 months
Secondary	IBD-Control	Mean IBD-Control scores at 0, 4, 8, 12, 16, 20, and 24 weeks	6 months
Secondary	SIBDQ	Mean quality of life (SIBDQ) scores at 0 and 26 weeks	6 months
Secondary	IBD knowledge	Mean IBD knowledge scores (CC-KNOW) at 0 and 26 weeks.	6 months