CClinicalTrials.gg
CompletedNCT03671980Updated Sep 14, 2018

IBD Self-management Website and Home Faecal Calprotectin Monitoring

An interventional study of My Medical record website in Inflammatory Bowel Diseases, Crohn Disease and Ulcerative Colitis, sponsored by University Hospital Southampton NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-14.

Sponsored by University Hospital Southampton NHS Foundation Trust · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
11
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

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

Keywords

  • Calprotectin
03

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's enrollment of 11 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

University Hospital Southampton NHS Foundation Trust is the lead sponsor of 147 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • 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

Interventions

  • OtherMy 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.

06

What researchers measure

Primary outcomes

  1. Faecal calprotectin testing completion rates

    Number of patients completing monthly faecal calprotectin testing

    Time frame: 6 months

  2. MyMR website usage

    Number of patients logging in to MyMR website at least monthly

    Time frame: 6 months

Secondary outcomes

  1. Recruitment

    Number of patients recruited per month

    Time frame: 6 months

  2. IBD email contact

    Number of email messaging contacts per patient to IBD specialist nursing team

    Time frame: 6 months

  3. IBD flareline calls

    Number of IBD flareline telephone calls per patient to IBD specialist nursing team

    Time frame: 6 months

  4. IT support contact

    Number of IT support email contacts per patient

    Time frame: 6 months

  5. Questionnaire response rates

    Response rates to pre-and post-study questionnaires

    Time frame: 6 months

  6. 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.

    Time frame: 6 months

  7. Calprotectin levels

    Mean faecal calprotectin levels at 0, 4, 8, 12, 16, 20, and 24 weeks.

    Time frame: 6 months

  8. IBD-Control

    Mean IBD-Control scores at 0, 4, 8, 12, 16, 20, and 24 weeks

    Time frame: 6 months

  9. SIBDQ

    Mean quality of life (SIBDQ) scores at 0 and 26 weeks

    Time frame: 6 months

  10. IBD knowledge

    Mean IBD knowledge scores (CC-KNOW) at 0 and 26 weeks.

    Time frame: 6 months

07

Study locations

1 site
  • Univesity Hospital Southampton NHS Foundation Trust
    Southampton, Hampshire SO16 6YD, United Kingdom
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03671980
Lead sponsor
University Hospital Southampton NHS Foundation Trust
Collaborators
University of Southampton
Responsible party
Sponsor
First posted
Sep 14, 2018
Start date
Apr 4, 2017
Primary completion
Apr 30, 2018
Completion
Jun 30, 2018
Last update
Sep 14, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion