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NCT Number: NCT06278662

Cohort Multiple Randomized Controlled Trial in Pediatric Asthma

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).

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Key information

Conditions

Pediatric Asthma Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medisch Spectrum Twente

Enschede, Overijssel, 7512KZ, Netherlands

Location status: Recruiting

Location contact

Job van der Palen, Full professor

CONTACT

[email protected]

0534872000

Mattienne Ricard van der Kamp, PhD

CONTACT

About this study

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of translating intervention ideas into funded research protocols, which may risk the eHealth intervention becoming outdated.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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

video directly observed therapy (vDOT)

Other

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.

Primary outcomes

  1. 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

  2. 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)

  3. 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.

  4. 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

  5. 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,

  6. 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

  7. 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.

  8. 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....)

  9. 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

Study contacts

Contact information is provided by the study sponsor or research team.

CIRCUSstudy

CONTACT

[email protected]

+31 53 487 23 10

Sponsors and collaborators

Lead sponsor

Mattienne van der Kamp

Other

Registry information

Official study title

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

Acronym: CIRCUS

Important dates

Study start
2024
Primary completion
2034
Study completion
2034
First posted
Feb 26, 2024
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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