Cohort Multiple Randomized Controlled Trial in Pediatric Asthma

Pediatric Asthma Clinical Trial

— CIRCUS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06278662
• Other study ID #: CIRCUS cmRCT
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: April 1, 2034

Study information

• Verified date: February 2024
• Source: Medisch Spectrum Twente
• Contact: CIRCUSstudy
• Phone: +31 53 487 23 10
• Email: circusstudie[@]mst.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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of translating intervention ideas into funded research protocols, which may risk the eHealth intervention becoming outdated.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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: April 1, 2034
• Est. primary completion date: April 1, 2034
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Pediatric Asthma

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mattienne van der Kamp

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)