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

Completed

• Conditions: IBD; Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis; Digestive System Disease; Patient Reported Outcome Measures
• Interventions: Other: Remote monitoring tool (infections questionnaire) validation

• Registration Number: NCT04151420
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-31
• Study First Submitted QC: 2019-11-04
• Study First Posted: 2019-11-05
• Study Start: 2020-06-15
• Primary Completion: 2021-09-21
• Study Completion: 2022-02-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-15
• Last Update Posted: 2022-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 584

Inclusion Criteria

• Age ≥ 18 years and diagnosed with IBD
• Included in eHealth clinical care-pathway using myIBDcoach

Exclusion Criteria

• Patients with insufficient knowledge of the Dutch language
• Patients not able to provide written informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult IBD patients	Remote monitoring tool (infections questionnaire) validation	-

Primary Outcome Measures

Name	Time	Method
Remote monitoring tool validation	24 months	Assess the reliability, construct validity and criterion validity of a PRO for infections in IBD patients as last step in the validation.

Secondary Outcome Measures

Name	Time	Method
Relation between mild/moderate and serious infectious complications	6-12 months	Assess the relation between patient reported infections and the risk for serious infectious complications
Relative risk of all infections	12 months	Assess the relative risk of all infections (mild, moderate and severe) in a real life population for IBD patients on different maintenance treatments

Trial Locations

Locations (2)

Maastricht University Medical Centrer; 🇳🇱 Maastricht, Netherlands

Zuyderland Medical Centre; 🇳🇱 Sittard, Netherlands