- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04151420
Real Life Remote Monitoring of Mild, Moderate and Severe Infectious Complications in IBD by Patient Reported Assessment
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
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:
- Assess the reliability, construct validity and criterion validity of a remote monitoring tool (questionnaire) for infections as last step in the validation
- Assess the relative risk of all infections (mild, moderate and severe) in a real-life population for IBD patients on different maintenance treatments
- Identify the predictors and risk factors of mild and moderate infections.
- Assess the relation between patient reported infections and the risk for serious infectious complications
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Maastricht, Netherlands
- Maastricht University Medical Centrer
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Sittard, Netherlands
- Zuyderland Medical Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Adult IBD patients
|
There will be no treatment intervention in the current study (no drugs will be used). Instead, patients are enrolled in a routine care eHealth care-pathway with myIBDcoach. MyIBDcoach (MijnIBDcoach, Dutch, Sananet Care B.V., Sittard, The Netherlands, https://www.mijnibdcoach.nl) is a web-based platform for home-monitoring and patient- provider communication in patients with IBD. Patients already using the myIBDcoach will be informed on this study. Patients will be asked to continue routine care including monitoring of PROs through the myIBDcoach. When a patient completes the infections disease questionnaire for the first time, this will be regarded as the starting point (T=0) for this patient. Patients will complete the questionnaire every three months after the starting point as part of their routine follow-up. Results from these questionnaires will be stored electronically and will be analyzed alongside medical records of GP's and drug delivery data from pharmacies. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Remote monitoring tool validation
Time Frame: 24 months
|
Assess the reliability, construct validity and criterion validity of a PRO for infections in IBD patients as last step in the validation.
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relative risk of all infections
Time Frame: 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
|
12 months
|
Relation between mild/moderate and serious infectious complications
Time Frame: 6-12 months
|
Assess the relation between patient reported infections and the risk for serious infectious complications
|
6-12 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: M J Pierik, MD, PhD, Maastricht University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MEC 2019-1115
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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