Loading clinical trials...
Loading clinical trials...
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Univesity Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom
Start Date
April 4, 2017
Primary Completion Date
April 30, 2018
Completion Date
June 30, 2018
Last Updated
September 14, 2018
11
ACTUAL participants
My Medical record website
OTHER
Lead Sponsor
University Hospital Southampton NHS Foundation Trust
Collaborators
NCT06226883
NCT07271069
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06975722