NCT04151420

Real Life Remote Monitoring of Mild, Moderate and Severe Infectious Complications in IBD by Patient Reported Assessment

Completed Last updated 16 June 2022

What this trial tests

trial testing Remote monitoring tool (infections questionnaire) validation in Inflammatory Bowel Diseases in 584 participants. Completed in 1 February 2022.

Timeline

15 June 2020

Primary endpoint
21 September 2021

1 February 2022

Quick facts

Lead sponsor	Maastricht University Medical Center
Status	Completed
Study type	OBSERVATIONAL
Enrollment	584
Start date	15 June 2020
Primary completion	21 September 2021
Estimated completion	1 February 2022
Sites	2 locations across Netherlands

Drugs / interventions tested

• Remote monitoring tool (infections questionnaire) validation

Conditions studied

• Inflammatory Bowel Diseases — all drugs for Inflammatory Bowel Diseases →
• Crohn Disease — all drugs for Crohn Disease →
• Ulcerative Colitis — all drugs for Ulcerative Colitis →
• IBD — all drugs for IBD →

Sponsor

Maastricht University Medical Center

Who can join

Adults 18 to 70, any sex, with Inflammatory Bowel Diseases or Crohn Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Inflammatory bowel disease (IBD) is a chronic relapsing immune mediated inflammatory disease (IMID) of the gastrointestinal tract. Like all IMIDs (e.g. rheumatoid arthritis, psoriasis) a complex interaction between a genetically altered immune response, the gut microbiota and environmental factors is causing the disease. Systemic suppression of the immune response with corticosteroids, immunomodulatory, biologicals and combination therapies increases the risk of opportunistic infections in IBD patients.

Data on mild and moderate infections in medically treated IBD patients is scarce, mainly since infections treated by the general practitioner or in an outpatient setting are not systematically registered in real life. To help gastroenterologists with clinical decision making, real world data with long term follow-up concerning the risk for infectious complications, is warranted.

Several observations underline the importance of real world data on mild and moderate infections in medically treated IBD patients. Mild and moderate infections mostly have a benign course, but they take longer to clear and have a large impact on (work)disability and quality of life in IBD patients. Recurrent infections influences peoples willingness to use a drug and negatively effects adherence. Furthermore, recurring mild and moderate infections might prognosticate serious infections, and systematic assessment of all infections could be used to timely adjust treatment regimens and prevent serious infections.

The investigators of this study previously developed a questionnaire on self-reported infections according to the FDA guideline for patient-reported outcome measures (PROM) by interviewing 36 patients with IBD and through input of expert meetings with gastroenterologists, IBD specialists, rheumatologists, immunologists and IBD-nurses. This questionnaire has already been implemented in myIBDcoach, a validated telemedicine system implemented in routine care for over 4000 patients with IBD in the Netherlands. Assesment of reliability and validity are the last steps in validation of this remote monitoring tool.

In the current study the investigators aim to:

1. Assess the reliability, construct validity and criterion validity of a remote monitoring tool (questionnaire) for infections as last step in the validation
2. Assess the relative risk of all infections (mild, moderate and severe) in a real-life population for IBD patients on different maintenance treatments
3. Identify the predictors and risk factors of mild and moderate infections.
4. Assess the relation between patient reported infections and the risk for serious infectious complications

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Remote care through telehealth for people with inflammatory bowel disease.
   Gordon M, Sinopoulou V, Lakunina S, Gjuladin-Hellon T, et al · · 2023 · cited 16× · PMID 37140025 · DOI 10.1002/14651858.cd014821.pub2
2. Development and Validation of a Remote Monitoring Tool for Assessment of Mild, Moderate, and Severe Infections in Inflammatory Bowel Disease.
   Rezazadeh Ardabili A, van Esser D, Wintjens D, Cilissen M, et al · · 2023 · cited 1× · PMID 36795060 · DOI 10.1093/ecco-jcc/jjad023
3. P488 The COVID19 pandemic impact on Inflammatory Bowel Disease Patients Management in a Romanian Tertiary Gastroenterology Centre
   Costache R, Iacob R, Vadan R, Stroie T, et al · · 2021