IBD Self-management Website and Home Faecal Calprotectin Monitoring

NCT ID: NCT03671980

Last Updated: 2018-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-04
• Study Completion Date: 2018-06-30

Brief 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.

Detailed 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.

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis; Self-care

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Web-intervention

30 participants using a self-management website and home faecal calprotectin smartphone monitoring instead of usual outpatient follow up as a means of managing their inflammatory bowel disease for 6 months after stopping an IBD medication.

Group Type: EXPERIMENTAL

My Medical record website

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

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

Sponsors

University of Southampton

OTHER

Sponsor Role: collaborator

University Hospital Southampton NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Univesity Hospital Southampton NHS Foundation Trust

Southampton, Hampshire, United Kingdom

Countries

United Kingdom

Other Identifiers

RHM MED1269

Identifier Type: -

Identifier Source: org_study_id