Clinical trial NCT04165265: The Use of Web-app Constant-Care in Patients With Acute Severe Ulcerative Colitis Treated With Rescue Therapy
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ulcerative Colitis
Telemedicine
Keywords: Hospitalization
Reduction in stay
Ulcerative Colitis
Inflammatory Bowel Disease
eHealth
Colectomy
Rescue therapy
Infliximab
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
Collaborators: name: Calpro AS
First posted: 2019-11-15
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Case-control trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Consecutive inclusion of patients hospitalized at North Zealand University Hospital (NOH) in Denmark between December 2019 and June 2020 with the diagnosis acute severe Ulcerative Colitis (UC) (expected 14-28 patients). The included patients will be matched with historical controls 1:3 (matched on age and sex). Controls will be extracted from medical records (2015-2019). Only historical controls who meet the inclusion criteria as well as receive Infliximab rescue therapy, when admitted to hospital due to the diagnosis acute severe UC, are included. This means that patients, who are responders to high dose glucocorticoids are excluded as historical controls.

At Day 0 all the included UC patients will receive an introduction and their own personal login to the Constant-Care (CC) web-application (Two Factor Authentication) as well as receive standard treatment with IV glucocorticoids. When the patients have received an introduction to CC, they will register their disease activity; Simple Clinical Colitis Activity index (SCCAI). This tool captures the patient's illness experience (Patient-Reported Outcomes, PROs). Furthermore, the patients are introduced and assisted with Fecal Calprotectin (FC) testing kit (CalproSmart). For this analysis, patients will receive a personal login to CalproSmart.

Beside the CC monitoring initiated at Day 0, the patient will be followed through standard monitoring (DSGH guidelines) such as vital parameters daily (minimum three times a day), conventional FC Elisa (send to Hvidovre), blood samples and the frequency of bowel movements. In addition, fecal samples will be collected from all patients to microbiome analysis for future use (I Suite nr: 03719, ID no: NOH-2015-017). A separate written informed consent is collected when patient want to participate in future research with microbiome analysis. Furthermore, the patients' medical history, disease course and Montreal classification will be examined. At follow-up (week 52) it is considered if the patient had a colectomy.

While hospitalized patients register in CC everyday as well as perform the FC test with CalproSmart. This is continued until discharge or whenever the patient is categorized as "green". A patient is classified as "green" when either SCCAI or FC are in the green zone (cut-off values: SCCAI; ≤ 2 (green), \> 2 - 5 (yellow) and \> 5 (red), FC; ≤ 200 mg/kg (green), 201-600 mg/kg (yellow), \> 600 (red)).

On or around Day 3 it is considered if patient is a responder to the initial treatment with glucocorticoids. In case only partial or no response is observed the patient is considered rescue therapy (Infliximab, IFX) if no contraindications are present. This divides the patients in two arms; responders and partial/non-responders.

Both groups will continue daily registration in CC and perform FC test while admitted to hospital or until classified as "green". After discharge the responder group will register in CC and perform FC on demand in case of relapse in disease. At follow up (week 52) responders will register in CC and perform the FC test.

Partial/non-responders will, after discharge, register in CC and perform FC test once every week in the following 7 weeks. Afterwards registration is done on demand in case of relapse in disease. A final registration in CC and FC test is done at follow up.

In CC, patients will register: SCCAI, S-IBDQ, WEB-DI and FC via CalproSmart.

Eligibility criteria: 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

Primary outcomes:
measure: Change in length of hospitalization due to the use of Constant-Care
timeFrame: One year after inclusion
Secondary outcomes:
measure: Quality of Life (S-IBDQ)
timeFrame: One year after inclusion
measure: Disability index (WEB-DI), The IBD Disk
timeFrame: One year after inclusion
measure: Fecal calprotectin level
timeFrame: One year after inclusion
measure: Time to clinical decision-making (days)
timeFrame: One year after inclusion
measure: Colectomy rate (at week 52)
timeFrame: One year after inclusion
measure: Disease course types
timeFrame: One year after inclusion
Other outcomes:
Locations:
city: Frederikssund
country: Denmark
facility: North Zealand University Hospital
Study officials:
affiliation: North Zealands University Hospital
name: Pia Munkholm, Professor
role: STUDY_DIRECTOR
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