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Are Rates of Colectomies, Resections, Mortalities and Cancer Reduced by Home Monitoring of IBD Patients ?

NCT03038984 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-04-15

No results posted yet for this study

Summary

This study is a side protocol/extension of 10 years of ClinicalTrials.gov ID: NCT02492555. The purpose of this study is to determine if the IBD patients doing home monitoring (screening themselves on demand (OD) or every 3 months) have relative reduced rates of colectomies, resections, mortalities and cancer after 11 years of web monitoring. The IBD patients are self-monitoring by web apps consisting of a short disease activity questionnaire (DA) and fecal calprotectin (FC) on any smart phone.

Conditions

  • Inflammatory Bowel Diseases

Interventions

BEHAVIORAL

At Home Screening procedure On demand

Home monitoring is a supportive treatment. Patients are randomized to screen themselves on demand

BEHAVIORAL

At Home Screening procedure every 3 months

Home monitoring is a supportive treatment. Patients are randomized to screen themselves every 3 months

Sponsors & Collaborators

  • Nordsjaellands Hospital

    lead OTHER

Principal Investigators

  • Pia Munkholm, Professor · North Zealand University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2026-08-31
Completion
2026-08-31

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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 NCT03038984 on ClinicalTrials.gov