Cohort Multiple Randomized Controlled Trial in Pediatric Asthma

NCT06278662 | Recruiting

• 1 other identifier: CIRCUS cmRCT
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Pediatric Asthma

Keywords

asthma; child; cohort studies; telemedicine

Outcome Measures

Primary Outcomes (9)

• Asthma control

  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

  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

  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

  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

  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

  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

  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

  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

  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)

Study Arms (2)

Intervention arm

EXPERIMENTAL

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)

Cohort control group

NO INTERVENTION

Interventions

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.

Intervention arm

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Is 4 to 18 years old
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mattienne van der Kamp: lead

Study Sites (1)

Medisch Spectrum Twente

Enschede, Overijssel, 7512KZ, Netherlands

RECRUITING

Related Publications (1)

• Ruuls T, Sprengers R, Hengeveld V, Thio B, Tabak M, Zagers D, van der Palen J, van der Kamp M. Cohort multiple randomized controlled trial in pediatric asthma to assess the long- and short-term effects of eHealth interventions: protocol of the CIRCUS study. Ther Adv Respir Dis. 2025 Jan-Dec;19:17534666251323192. doi: 10.1177/17534666251323192. Epub 2025 Mar 12.

  PMID: 40071339 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

CIRCUSstudy

CONTACT

+31 53 487 23 10; circusstudie@mst.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The masking is dependent of the future interventions.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: dr.

Model Details: The CIRCUS study has a cmRCT design to determine the effects of (eHealth) interventions in asthmatic children. Children are included in the prospective dynamic cohort during outpatient visits. Children and/or their parents are asked to sign consent for three parts of the cmRCT, of which at least consent for part 1 is needed to be eligible for participation: 1. Participating in the prospective dynamic cohort and data collection. 2. Willingness to participate in interventions. 3. Willingness to fill out additional questionnaires and/or do additional measurements if a child is randomly selected for the control group of an intervention, which uses additional outcomes.

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 26, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): April 1, 2034
• Study Completion (Estimated): April 1, 2034
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)