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

NCT04165265 | Unknown DMC

• 1 other identifier: H-19047104
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis; Telemedicine

Keywords

Hospitalization; Reduction in stay; Ulcerative Colitis; Inflammatory Bowel Disease; eHealth; Colectomy; Rescue therapy; Infliximab

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Quality of Life (S-IBDQ)

  One year after inclusion

• Disability index (WEB-DI), The IBD Disk

  One year after inclusion

• Fecal calprotectin level

  One year after inclusion

• Time to clinical decision-making (days)

  One year after inclusion

• Colectomy rate (at week 52)

  One year after inclusion

Study Arms (1)

Responders and Partial/non-responders

EXPERIMENTAL

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.

Device: Constant-Care

Interventions

Constant-Care DEVICE

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

Responders and Partial/non-responders

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Any present enteric infection
• Receiving per oral glucocorticoids
• Contraindications for IFX therapy, including;
• Former inadequate response to IFX
• Disease relapse in spite of current treatment with IFX
• Intolerance or unacceptable side-effects to IFX
• Active or latent TB
• Cardiac failure (NYHA III or IV)
• 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

Sponsors & Collaborators

• Nordsjaellands Hospital: lead
• Calpro AS: collaborator

Study Sites (1)

North Zealand University Hospital

Frederikssund, 3600, Denmark

RECRUITING

Related Publications (25)

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MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Pia Munkholm, Professor

  North Zealands University Hospital

  STUDY DIRECTOR

Central Study Contacts

Malte Rosager Hansen, Research assistant

CONTACT

+45 4829 6765; luca.malte.rosager.hansen@regionh.dk

Pia Munkholm, Professor

CONTACT

+45 4829 2078; pia.munkholm@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Case-control trial

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: November 15, 2019
• Study Start: December 3, 2019
• Primary Completion: June 30, 2021
• Study Completion: December 31, 2021
• Last Updated: December 5, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)