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

NCT04165265 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2019-12-05

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Calpro AS

    collaborator OTHER

  • Nordsjaellands Hospital

    lead OTHER

Principal Investigators

  • Pia Munkholm, Professor · North Zealands University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-03
Primary Completion
2021-06-30
Completion
2021-12-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04165265 on ClinicalTrials.gov