IBD Self-management Website and Home Faecal Calprotectin Monitoring

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

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis; Self-care
• Intervention / Treatment: Other: My Medical record website

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Hampshire
    • Southampton, Hampshire, United Kingdom, SO16 6YD
      • Univesity Hospital Southampton NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Faecal calprotectin testing completion rates	Number of patients completing monthly faecal calprotectin testing	6 months
MyMR website usage	Number of patients logging in to MyMR website at least monthly	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment	Number of patients recruited per month	6 months
IBD email contact	Number of email messaging contacts per patient to IBD specialist nursing team	6 months
IBD flareline calls	Number of IBD flareline telephone calls per patient to IBD specialist nursing team	6 months
IT support contact	Number of IT support email contacts per patient	6 months
Questionnaire response rates	Response rates to pre-and post-study questionnaires	6 months
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
Calprotectin levels	Mean faecal calprotectin levels at 0, 4, 8, 12, 16, 20, and 24 weeks.	6 months
IBD-Control	Mean IBD-Control scores at 0, 4, 8, 12, 16, 20, and 24 weeks	6 months
SIBDQ	Mean quality of life (SIBDQ) scores at 0 and 26 weeks	6 months
IBD knowledge	Mean IBD knowledge scores (CC-KNOW) at 0 and 26 weeks.	6 months

Collaborators and Investigators

• Sponsor: University Hospital Southampton NHS Foundation Trust
• Collaborators: University of Southampton

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2017
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: June 13, 2017
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (Actual): September 14, 2018

Study Record Updates

• Last Update Posted (Actual): September 14, 2018
• Last Update Submitted That Met QC Criteria: September 13, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Calprotectin
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases
• Other Study ID Numbers: RHM MED1269

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No