Ulcerative Colitis Clinical Trial
Official title:
Reduction in Length of Hospitalization in Patients With Acute Severe Ulcerative Colitis Treated With Rescue Therapy With Infliximab by the Use of Web-app Constant-Care. One Year Follow-up, Inclusive Colectomy Rate.
The primary aim is to evaluate if introduction of eHealth in its form of the web application
Constant-Care (https://ibd.constant-care.com) could reduce the length of hospitalization in
patients with acute severe Ulcerative Colitis treated with infliximab. This is relative to
historical controls extracted from medical records.
Patients will self-measure on the web-application while hospitalized as well as after
discharge. At the web-application different questionnaires are filled out and a fecal
calprotectin (FC) analysis is performed on a smartphone. The final follow up is one year
after admission.
Status | Recruiting |
Enrollment | 28 |
Est. completion date | December 31, 2021 |
Est. primary completion date | June 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients with the diagnosis acute severe UC/IBDU, ECCO guidelines; Bloody diarrhea = 6/day plus minimum one of following: Pulse > 90/min, Temperature > 37.8 °C, Hemoglobin < 105 g/l, ESR > 30 mm/h, CRP > 30 - Hospitalized at NOH, Hillerød - UC patients receiving IV glucocorticoids - UC patients who can read, speak and understand Danish - Have a smartphone - UC patients who can manage going on Internet - Above 18 years of age Exclusion Criteria: - Any present enteric infection - Receiving per oral glucocorticoids - Contraindications for IFX therapy, including; 1. Former inadequate response to IFX 2. Disease relapse in spite of current treatment with IFX 3. Intolerance or unacceptable side-effects to IFX 4. Active or latent TB 5. Cardiac failure (NYHA III or IV) 6. Demyelinating disorders - Former gastrointestinal surgery - UC patients with any severe mental disturbance and/or alcohol/other drug abuse - UC patients with language barrier - Below 18 years of age |
Country | Name | City | State |
---|---|---|---|
Denmark | North Zealand University Hospital | Frederikssund |
Lead Sponsor | Collaborator |
---|---|
Nordsjaellands Hospital | Calpro AS |
Denmark,
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* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in length of hospitalization due to the use of Constant-Care | The primary aim is to evaluate if introduction of eHealth in its form of the web application Constant-Care could change the length of hospitalization in patients with acute severe Ulcerative Colitis treated with infliximab. This is relative to historical controls extracted from medical records. | One year after inclusion | |
Secondary | Quality of Life (S-IBDQ) | S-IBDQ is a clinical tool, which measure the subjective health related quality of life (HRQoL) in patients with an IBD diagnosis. The questionnaire compromises 10 questions derived from the full version IBDQ. Questions cover patients physical health, psychological health, social relationships and environment. The total score ranges from 10 to 70, where 70 indicates best health (classified as "green" in CC when S-IBDQ > 50). Evidence has shown that the tool is able to discriminate between patients with active and inactive disease. Furthermore, evidence indicates that S-IBDQ correlates with other clinical tools such as the SCCAI. Interesting questions concerning the S-IBDQ are: How will the S-IBDQ change over time (responder and non-responder)? What are the differences between responders and non-responders? What is the impact of S-IBDQ in relation to clinical decision-making? |
One year after inclusion | |
Secondary | Disability index (WEB-DI), The IBD Disk | The IBD Disk was developed from selected elements from the IBD disability index (IBD-DI), which are most likely to be important in assessing a patient's disease burden and at the same time had relevance to both the patient and physician. The IBD-DI consists of 28 questions and is a physician- administrated tool, which evaluates the IBD patients' functional status. The IBD Disk consists of 10 elements, which are ranked from 0 to 10; Abdominal pain, regulating defecation, interpersonal interactions, education/work, sleep, energy, emotions, body image, sexual functions and joint pain. The result is visually illustrated in a disc. Interesting questions concerning the WEB-DI are: How will the WEB-DI change over time (responder and non-responder)? What are the differences between responders and non-responders? What is the impact of WEB-DI in relation to clinical decision-making? |
One year after inclusion | |
Secondary | Fecal calprotectin level | FC release is related to cell stress/damage and is a very sensitive marker for inflammation in the gastrointestinal tract. It is available as a non-invasive tool for monitoring and adjustment of treatment in UC as it relates to relapse in the disease. Furthermore, there is a high correlation between FC level measured in stool and the histological and endoscopic findings. In the study FC would be analyzed with conventional FC Elisa and by the use of Calpro Smart Interesting questions concerning the fecal calprotectin level are: How will the calprotectin level change over time (responder and non-responder)? What are the differences between responders and non-responders? What is the lead time between fecal calprotectin determination via CalproSmart and conventional Elisa? What is the impact of the immediate calprotectin analysis via CalproSmart to clinical decision-making? |
One year after inclusion | |
Secondary | Time to clinical decision-making (days) | The conventional treatment of patients with acute severe UC is IV glucocorticoids. No response to glucocorticoids is associated with colectomy in 85% of cases during the actual admission if rescue therapy is not initiated. Infliximab, which is one of the therapeutic alternatives, has been found safe and effective as rescue therapy (reduction in colectomy rate) in patients with acute moderate to severe UC. The response to the treatment with glucocorticoids is evaluated at Day 3-5. If no or only partial response is observed, it is considered if the patient is a candidate for the rescue therapy with IFX between Day 3 and 5. However, Day 3-5 is rarely being withhold in everyday life in hospital. Interesting questions concerning the time to clinical decision-making: Will time to clinical decision-making change relative to historical controls? This would be an estimate relative to the length of hospitalization. What are factors that determine whether to start infliximab or not? |
One year after inclusion | |
Secondary | Colectomy rate (at week 52) | Will the colectomy rate change (decrease/increase/unaffected) compared with the historical controls? | One year after inclusion | |
Secondary | Disease course types | The disease course of UC patients is varying. Overall, they are considered in four subgroups characterized based on relations between periods of active disease and remission. The groups are as follows: High disease activity in the beginning, followed by decreasing disease activity Low disease activity in the beginning, followed by increasing disease activity Chronic disease course with constant disease activity Chronic disease course with fluctuations in disease activity Interesting questions concerning disease course types: Are the patients disease course changed over time? Will there be any differences between responders and non-responders? Does the initial disease course have an impact on the outcome of the admission? |
One year after inclusion |
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