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
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.
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
Participants will be encouraged to use all functions of the website at least monthly:
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.
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 →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.
Exclusion Criteria:
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.
Faecal calprotectin testing completion rates
Number of patients completing monthly faecal calprotectin testing
Time frame: 6 months
MyMR website usage
Number of patients logging in to MyMR website at least monthly
Time frame: 6 months
Recruitment
Number of patients recruited per month
Time frame: 6 months
IBD email contact
Number of email messaging contacts per patient to IBD specialist nursing team
Time frame: 6 months
IBD flareline calls
Number of IBD flareline telephone calls per patient to IBD specialist nursing team
Time frame: 6 months
IT support contact
Number of IT support email contacts per patient
Time frame: 6 months
Questionnaire response rates
Response rates to pre-and post-study questionnaires
Time frame: 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.
Time frame: 6 months
Calprotectin levels
Mean faecal calprotectin levels at 0, 4, 8, 12, 16, 20, and 24 weeks.
Time frame: 6 months
IBD-Control
Mean IBD-Control scores at 0, 4, 8, 12, 16, 20, and 24 weeks
Time frame: 6 months
SIBDQ
Mean quality of life (SIBDQ) scores at 0 and 26 weeks
Time frame: 6 months
IBD knowledge
Mean IBD knowledge scores (CC-KNOW) at 0 and 26 weeks.
Time frame: 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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University Hospital Southampton NHS Foundation Trust