Clinical trial NCT03671980: IBD Self-management Website and Home Faecal Calprotectin Monitoring
Official title: Feasibility and Acceptability of an Inflammatory Bowel Disease Self-management Website and Home Faecal Calprotectin Monitoring After Treatment De-escalation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Crohn Disease
Ulcerative Colitis
Self-care
Keywords: Calprotectin
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Southampton
First posted: 2018-09-14
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility study
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Faecal calprotectin testing completion rates
timeFrame: 6 months
measure: MyMR website usage
timeFrame: 6 months
Secondary outcomes:
measure: Recruitment
timeFrame: 6 months
measure: IBD email contact
timeFrame: 6 months
measure: IBD flareline calls
timeFrame: 6 months
measure: IT support contact
timeFrame: 6 months
measure: Questionnaire response rates
timeFrame: 6 months
measure: Retention rate
timeFrame: 6 months
measure: Calprotectin levels
timeFrame: 6 months
measure: IBD-Control
timeFrame: 6 months
measure: SIBDQ
timeFrame: 6 months
measure: IBD knowledge
timeFrame: 6 months
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: Univesity Hospital Southampton NHS Foundation Trust
state: Hampshire
Study officials:
References: