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The Use of Web-app Constant-Care in Patients With Acute Severe Ulcerative Colitis Treated With Rescue Therapy

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ClinicalTrials.gov Identifier: NCT04165265
Recruitment Status : Recruiting
First Posted : November 15, 2019
Last Update Posted : December 5, 2019
Sponsor:
Collaborator:
Calpro AS
Information provided by (Responsible Party):
Nordsjaellands Hospital

Tracking Information
First Submitted Date  ICMJE November 8, 2019
First Posted Date  ICMJE November 15, 2019
Last Update Posted Date December 5, 2019
Actual Study Start Date  ICMJE December 3, 2019
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2019)
Change in length of hospitalization due to the use of Constant-Care [ Time Frame: One year after inclusion ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04165265 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2019)
  • Quality of Life (S-IBDQ) [ Time Frame: One year after inclusion ]
    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?
  • Disability index (WEB-DI), The IBD Disk [ Time Frame: One year after inclusion ]
    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?
  • Fecal calprotectin level [ Time Frame: One year after inclusion ]
    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?
  • Time to clinical decision-making (days) [ Time Frame: One year after inclusion ]
    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?
  • Colectomy rate (at week 52) [ Time Frame: One year after inclusion ]
    Will the colectomy rate change (decrease/increase/unaffected) compared with the historical controls?
  • Disease course types [ Time Frame: One year after inclusion ]
    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:
    1. High disease activity in the beginning, followed by decreasing disease activity
    2. Low disease activity in the beginning, followed by increasing disease activity
    3. Chronic disease course with constant disease activity
    4. 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?
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Use of Web-app Constant-Care in Patients With Acute Severe Ulcerative Colitis Treated With Rescue Therapy
Official Title  ICMJE 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Case-control trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Ulcerative Colitis
  • Telemedicine
Intervention  ICMJE Device: Constant-Care
Constant-Care (CC) (https://ibd.constant-care.com) is a web-application and contains an education and a disease monitoring package. An algorithm is established in the disease monitoring package, which consist of two variables; fecal calprotectin (FC) and a disease activity questionnaire (validated), Simple Clinical Colitis Activity index (SCCAI) for UC. The FC is obtained through CalproSmart app (it only takes 18 min) and the questionnaire is filled out in CC. Afterwards, the data are analyzed by CC and presented in a Total Inflammatory Burden Score (TIBS) as well as a visual "traffic light" of disease for the patients
Study Arms  ICMJE Experimental: Responders and Partial/non-responders

The definition of responders to glucocorticoids is: "Bowel movements ≤ 3/day without blood and normalization of CRP". In the study, this is supported by CC.

The definition of non-responders is: "Bowel movements > 8/day or 3-8/day and CRP > 45 mg/l." The decision if the patient is a non-responder is supported by CC.

Questionnaires in CC and FC analysis with CalproSmart are performed every day until discharge or when classified as "green" in CC. After discharge questionnaires in CC and FC analysis are performed once every week in the following 7 weeks and a final registration at week 52. In case of disease relapse between week 7 and 52 registration in CC and FC analysis are performed on demand. Fecal samples for future use (biobank) and FC Elisa as well as blood samples are done before administration of IFX (week 2 and 6). At follow-up (week 52) it is considered whether the patient underwent colectomy or not.

Intervention: Device: Constant-Care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 14, 2019)
28
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Malte Rosager Hansen, Research assistant +45 4829 6765 luca.malte.rosager.hansen@regionh.dk
Contact: Pia Munkholm, Professor +45 4829 2078 pia.munkholm@regionh.dk
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04165265
Other Study ID Numbers  ICMJE H-19047104
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nordsjaellands Hospital
Study Sponsor  ICMJE Nordsjaellands Hospital
Collaborators  ICMJE Calpro AS
Investigators  ICMJE
Study Director: Pia Munkholm, Professor North Zealands University Hospital
PRS Account Nordsjaellands Hospital
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP