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| Name | Class |
|---|---|
| University of Southampton | OTHER |
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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:
Secure email messaging service
IBD educational material
Stool, nutritional and flare journals
Blood and test results
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Web-intervention | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| My Medical record website | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univesity Hospital Southampton NHS Foundation Trust | Southampton | Hampshire | SO16 6YD | United Kingdom |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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Feasibility study
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| 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 |
| D003092 | Colitis |
| D003108 | Colonic Diseases |