NCT06278662: CIRCUS

Cohort Multiple Randomized Controlled Trial in Pediatric Asthma

Recruiting now NA Last updated 26 November 2024

What this trial tests

NA trial testing video directly observed therapy (vDOT) in Pediatric Asthma in 300 participants. Currently enrolling.

Timeline

1 April 2024

Primary endpoint
1 April 2034

1 April 2034

Quick facts

Lead sponsor	Mattienne van der Kamp
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	300
Start date	1 April 2024
Primary completion	1 April 2034
Estimated completion	1 April 2034
Sites	1 location across Netherlands

Drugs / interventions tested

• video directly observed therapy (vDOT)

Conditions studied

• Pediatric Asthma — all drugs for Pediatric Asthma →

Sponsor

Mattienne van der Kamp

Who can join

Adults 4 to 18, any sex, with Pediatric Asthma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cohort multiple randomized controlled trial in pediatric asthma to assess the long- and short-term effects of eHealth interventions: protocol of the CIRCUS study.
   Ruuls T, Sprengers R, Hengeveld V, Thio B, et al · · 2025 · cited 2× · PMID 40071339 · DOI 10.1177/17534666251323192
2. Cohort multiple Randomized Controlled trial in pediatric asthma to assess the long- and short-term effects of eHealth interventions: protocol of the CIRCUS study
   Ruuls T, Sprengers R, Hengeveld V, Thio B, et al · · 2024 · DOI 10.21203/rs.3.rs-4252066/v1