Clinical trial NCT04151420: Real Life Remote Monitoring of Mild, Moderate and Severe Infectious Complications in IBD by Patient Reported Assessment
Official title: Validation and Implementation of a Digital Patient Reported Remote Monitoring Tool to Systematically Monitor Mild, Moderate and Severe Infectious Complications in IBD Patients in Routine Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Crohn Disease
Ulcerative Colitis
IBD
Digestive System Disease
Patient Reported Outcome Measures
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Takeda
First posted: 2019-11-05
Enrollment: 584
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with medically treated inflammatory bowel disease (IBD) (ulcerative colitis and Crohn's disease) included in the eHealth clinical care-pathway using myIBDcoach and followed on the outpatient clinic of Maastricht University Medical Centre or Zuyderland Medical Centre.

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


Eligibility criteria: 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

Primary outcomes:
measure: Remote monitoring tool validation
timeFrame: 24 months
Secondary outcomes:
measure: Relative risk of all infections
timeFrame: 12 months
measure: Relation between mild/moderate and serious infectious complications
timeFrame: 6-12 months
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centrer
city: Sittard
country: Netherlands
facility: Zuyderland Medical Centre
Study officials:
affiliation: Maastricht University
name: M J Pierik, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: