Pediatric AsthmaCIRCUSNCT06278662
Cohort Multiple Randomized Controlled Trial in Pediatric Asthma
A study testing video directly observed therapy (vDOT) in people with Pediatric Asthma, run by Mattienne van der Kamp at 1 site in Netherlands.
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). Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Pediatric Asthma
- What is being tested?
- video directly observed therapy (vDOT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Apr 2024to 1 Apr 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 12Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Medisch Spectrum Twente
Enschede, Overijssel, 7512KZ
Job van der Palen, Full professor, 0534872000, mst@mst.nl
Mattienne Ricard van der Kamp, PhD
About this study
Official title: 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:
Read more
- 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).
Read the 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.
- Conditions
- Pediatric Asthma
- Being tested
- video directly observed therapy (vDOT)
- Keywords
- asthma, child, cohort studies, telemedicine
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: video directly observed therapy (vDOT) |
| Cohort control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma control
C-ACT/ACT: (Childhood) Asthma Control Test
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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,
Measured: 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
Measured: 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.
Measured: 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....)
Measured: 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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start1 Apr 2024
- Primary completion1 Apr 2034 (estimated)
- Study completion1 Apr 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mattienne van der Kamp
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mattienne van der Kamp, Medisch Spectrum Twente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278662
- Sponsor's protocol ID
- CIRCUS cmRCT
- Acronym
- CIRCUS
- Status last verified
- Nov 2024
- First submitted
- 12 Feb 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40071339
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Multiple Randomized Controlled Trial in Pediatric Asthma: Infrastructure to Assess the Long- and Short-term Effects of (eHealth) Interventions.
- ClinicalTrials.gov ID
- NCT06278662
- Acronym / sponsor ID
- CIRCUS / CIRCUS cmRCT
- Conditions
- Pediatric Asthma
- Keywords
- asthma, child, cohort studies, telemedicine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Mattienne van der KampUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Apr 2034 (estimated)
- Study completion
- 1 Apr 2034 (estimated)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: video directly observed therapy (vDOT)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. |
| Cohort control group | No intervention | – |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- 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]:
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Intervention arm |
Primary outcome
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
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)
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.
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
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,
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
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.
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....)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Derived from this study: PubMed 40071339Ruuls 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.
- Individual participant dataSharing planned: No
Related trials for Pediatric Asthma
Active, not recruitingPhase 3
A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma
Asthma
RecruitingObservational study
Remote Monitoring of Asthma in Children and Young People
Asthma Childhood, Asthma Attack
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Active, not recruiting
Community Health Equity Accelerator (CHEA) Pediatric Asthma Intervention
Asthma in Children
Active, not recruiting
Technology-Enhanced Asthma Care in Children at Clinic and Home Study
Asthma in Children, Chronic Diseases in Children
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing video directly observed therapy (vDOT) in people with Pediatric Asthma, run by Mattienne van der Kamp at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CIRCUSstudy (+31 53 487 23 10, circusstudie@mst.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06278662, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.