Cohort Multiple Randomized Controlled Trial in Pediatric Asthma (CIRCUS)

February 19, 2024 updated by: Mattienne van der Kamp

Cohort Multiple Randomized Controlled Trial in Pediatric Asthma: Infrastructure to Assess the Long- and Short-term Effects of (eHealth) Interventions.

The overarching goal of this study is to optimize pediatric asthma care and to continuously evaluate variations/innovations of the care (including transformation to remote eHealth care).

Primary Objectives within cmRCT cohort:

  • Provide a framework for multiple randomized (eHealth) interventions for asthmatic children
  • Generate short- and long-term data on Quality of life (QoL), asthma outcomes (asthma control, lung function), quality of care, self-management capacity, healthcare use, and therapy compliance in a representative secondary care pediatric asthma cohort.

Secondary Objectives within cmRCT cohort:

  • Evaluate current pediatric asthma care at the Pediatric department of Medisch Spectrum Twente, in order to explore possible improvements for the pediatric asthma care.
  • Compare the short and long-term asthma outcomes between the eHealth care path and the outpatient care path.
  • Compose patient risk profiles that include both personal, clinical and exposome markers and clinical asthma endpoints (for example clinical admission/exacerbations).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Rationale: Testing of eHealth interventions seems crucial since eHealth provides possibilities to obtain a real-time and objective view of asthma symptoms. Traditional randomized controlled trials(RCTs) face challenges in evaluating the effect of multiple eHealth components separately and in the long process of translating intervention ideas into funded research protocols, which may risk the eHealth intervention becoming outdated.

Objective: This study aims to provide a framework to assess the effect of (eHealth) interventions and generate short- and long-term data on clinical and patient-reported outcomes of asthmatic children using a cohort multiple Randomized Controlled Trial (cmRCT) design.

Study design: The CIRCUS study is a cmRCT designed to test multiple eHealth interventions in eligible asthmatic children (4-18 years old, treated in MST) within a cohort. Observational clinical data is collected of these children and both the children and their parents regularly complete questionnaires. In addition, a random selection of eligible children is approached for participation in interventions while the non-selected children remain in the control group.

Study population: Included children are 4-18 years old, diagnosed with asthma following the Global Initiative for Asthma (GINA) criteria and treated in Medisch Spectrum Twente at Enschede.

Main study parameters/endpoints: Primary outcome measures are Quality of life(QoL), asthma outcomes(asthma control, lung function), quality of care, self-management capacity, healthcare use, and therapy compliance.

Nature and extent of the burden and risks associated with participation, benefit, and group relatedness: Children and parents fill out questionnaires on a monthly and half-yearly basis. The questionnaires include: (C)-ACT, PAQLQ, CSQ-4, and PAM-13. In consultation with the patient panel we chose the shortest validated questionnaires to reduce the study burden. Other data (for example healthcare use) is collected by the researchers. No relevant risks were found in the risk analysis. We chose to use this group of children in this study as asthma management in children differs from that in adults.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Is 4 to 18 years old
  • Is patient at the children's department at Medisch Spectrum Twente at moment of inclusion

  • Is diagnosed with asthma by a pediatrician following the Global Initiative for Asthma(GINA) guidelines 2022 [8]:

    *Medical history fitting asthma diagnosis:

  • Based on (typical) symptoms: (nighttime) wheezing, dyspnea, coughing (triggered by either viral infections, exercise, allergens or weather changes)
  • (Possibly) supplemented with a family history/atopy

AND

*Spirometry variable expiratory airflow limitation by at least one of these criteria:

  • FEV1/FVC reduced compared to lower limit of normal(Z-score ≤ -1.64)
  • Positive bronchodilator responsiveness(increase FEV1>12%)
  • Positive Exercise Challenge Test (ECT)(decrease FEV1≥ 13%)
  • Excessive variation in lung function (LF) between tests from different dates (variation FEV1>12% pred)

Exclusion Criteria:

  • The child and/or parent(s) has/have insufficient command of the Dutch language resulting in the insufficient ability to understand and/or answer questions

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention arm
The cohort multiple Randomised Controlled Trial (also known as TwiCs 'trials within cohorts') is a prospective study design in which (eHealth) intervention arms will be established over time. The interventions will be evaluated on the primary outcome measures of the cohort.
Other: video directly observed therapy (vDOT)
The first intervention of within the CIRCUS study is video directly observed therapy (vDOT). The intervention consists of taking recording of daily inhalation use and receiving four feedback sessions of an asthma nurse based on these home recordings.
No Intervention: Cohort control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asthma control
Time Frame: monthly (until the patient turns 18 years old, has no astma diagnosis anymore or is no longer under treatment of the MST hospital, whichever came first, assessed up to 168months)
C-ACT/ACT: (Childhood) Asthma Control Test
monthly (until the patient turns 18 years old, has no astma diagnosis anymore or is no longer under treatment of the MST hospital, whichever came first, assessed up to 168months)
Pediatric Asthma Quality of Life
Time Frame: once per 6 months (until the patient turns 18 years old, has no astma diagnosis anymore or is no longer under treatment of the MST hospital, whichever came first, assessed up to 168months)
Pediatric Asthma Quality of Life Questionnaire (PAQLQ)
once per 6 months (until the patient turns 18 years old, has no astma diagnosis anymore or is no longer under treatment of the MST hospital, whichever came first, assessed up to 168months)
Quality of care
Time Frame: once per 6 months (until the patient turns 18 years old, has no astma diagnosis anymore or is no longer under treatment of the MST hospital, whichever came first, assessed up to 168months)
CSQ-4: Client Satisfaction Questionnaire.
once per 6 months (until the patient turns 18 years old, has no astma diagnosis anymore or is no longer under treatment of the MST hospital, whichever came first, assessed up to 168months)
Self-management capacity
Time Frame: once per 6 months (until the patient turns 18 years old, has no astma diagnosis anymore or is no longer under treatment of the MST hospital, whichever came first, assessed up to 168months)
PAM-13: patient activation measurement
once per 6 months (until the patient turns 18 years old, has no astma diagnosis anymore or is no longer under treatment of the MST hospital, whichever came first, assessed up to 168months)
Healthcare use
Time Frame: continuous (until the patient turns 18 years old, has no astma diagnosis anymore or is no longer under treatment of the MST hospital, whichever came first, assessed up to 168months)
hospital admissions, outpatient visits, telephonic consultations, diagnostics,
continuous (until the patient turns 18 years old, has no astma diagnosis anymore or is no longer under treatment of the MST hospital, whichever came first, assessed up to 168months)
Wheather data
Time Frame: daily (until the patient turns 18 years old, has no astma diagnosis anymore or is no longer under treatment of the MST hospital, whichever came first, assessed up to 168months)
Wheather data (hourly): Temperature, humidity, rainfall
daily (until the patient turns 18 years old, has no astma diagnosis anymore or is no longer under treatment of the MST hospital, whichever came first, assessed up to 168months)
Air quality
Time Frame: daily (until the patient turns 18 years old, has no astma diagnosis anymore or is no longer under treatment of the MST hospital, whichever came first, assessed up to 168months)
Hourly data on: Nitrogen dioxide(NO2), Nitric oxide(NO), Ozone(O3), Particulate matter(PM10), Particulate matter(PM2.5), Ultra Fine Particles(UFP) Carbon monoxide(CO2), Sulpher dioxide(SO2) Pollencount (daily): birch, grasses etc.
daily (until the patient turns 18 years old, has no astma diagnosis anymore or is no longer under treatment of the MST hospital, whichever came first, assessed up to 168months)
Pollen
Time Frame: daily (until the patient turns 18 years old, has no astma diagnosis anymore or is no longer under treatment of the MST hospital, whichever came first, assessed up to 168months)
Pollencount (daily): Treepolls (Birch, Hazel, Alder, etc...) & bushes/grasspolls (grass, worm-wood, ambrosia, goose grass etc....)
daily (until the patient turns 18 years old, has no astma diagnosis anymore or is no longer under treatment of the MST hospital, whichever came first, assessed up to 168months)
Medication delivery
Time Frame: continous (until the patient turns 18 years old, has no astma diagnosis anymore or is no longer under treatment of the MST hospital, whichever came first, assessed up to 168months)

LSP list via pharmacy of Medisch Spectrum Twente

  • Name medicine
  • Date of issue
  • Dose
  • Expected period of use
  • Quantity provided
continous (until the patient turns 18 years old, has no astma diagnosis anymore or is no longer under treatment of the MST hospital, whichever came first, assessed up to 168months)

Collaborators and Investigators

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

Sponsor

Mattienne van der Kamp

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 (Estimated)

April 1, 2024

Primary Completion (Estimated)

April 1, 2034

Study Completion (Estimated)

April 1, 2034

Study Registration Dates

First Submitted

February 12, 2024

First Submitted That Met QC Criteria

February 19, 2024

First Posted (Actual)

February 26, 2024

Study Record Updates

Last Update Posted (Actual)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIRCUS cmRCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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