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

June 15, 2022 updated by: Maastricht University Medical Center

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:

  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

Study Overview

Study Type

Observational

Enrollment (Actual)

584

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Maastricht, Netherlands
        • Maastricht University Medical Centrer
      • Sittard, Netherlands
        • Zuyderland Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: M J Pierik, MD, PhD, Maastricht University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2020

Primary Completion (Actual)

September 21, 2021

Study Completion (Actual)

February 1, 2022

Study Registration Dates

First Submitted

October 31, 2019

First Submitted That Met QC Criteria

November 4, 2019

First Posted (Actual)

November 5, 2019

Study Record Updates

Last Update Posted (Actual)

June 16, 2022

Last Update Submitted That Met QC Criteria

June 15, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data will be made available to other researchers on demand. Patients will be asked to give informed consent to share the collected data with third parties for future research.

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

No

Studies a U.S. FDA-regulated device product

No

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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